Non-Small Cell Lung Cancer
Conditions
Keywords
EGFRm - Epidermal Growth Factor Receptor Mutation, Advanced EGFRm (del19 or L858R +/- T790M NSCLC
Brief summary
This is a Phase 1/2 study of PF-06747775 as a single agent and in combination with other cancer treatments in patients with advanced EGFRm NSCLC. The overall clinical study consists of a Phase 1 single agent dose-escalation and expansion part to determine the RP2D of PF-06747775 single agent in patients with previously-treated EGFRm NSCLC followed by sequential evaluations of PF-06747775 at the RP2D in 3 different clinical scenarios as detailed below: * Cohort 1: Phase 2 evaluation of PF-06747775 as a single agent in previously untreated patients with advanced EGFRm NSCLC, * Cohort 2: Phase 1b single arm evaluation of PF-06747775 in combination with palbociclib (Cohort 2A) followed by Phase 2 randomized evaluation of PF 06747775 in combination with palbociclib vs PF-06747775 single agent (Cohort 2B) in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M), and * Cohort 3: Phase 1b evaluation of PF-06747775 in combination with avelumab in previously-treated patients with EGFRm NSCLC with a secondary T790M mutation (del 19 and T790M or L858R and T790M).
Detailed description
There remains an unmet medical need to develop EGFR TKI agents that effectively target both the single activating mutations of del 19 and L858R, and the secondary resistance mutation T790M, while sparing WT EGFR. Drugs active against the resistance mutation will enable molecularly targeted therapy with a more favorable toxicity profile than the current standard of cytotoxic chemotherapy platinum based doublets. Furthermore, by having a wide margin of selectivity favoring the EGFR mutants versus WT EGFR, PF 06747775 is likely to be positioned to improve patient outcomes from an efficacy and safety perspective.
Interventions
DRUGPF-06747775
DRUGPalbociclib
DRUGAvelumab
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Partial Inclusion criteria: Evidence of histologically or cytologically confirmed diagnosis of locally advanced or metastatic EGFRm (del 19 or L858R) NSCLC: 1. As detected by local EGFR mutation test that includes QIAGEN therascreen EGFR RGQ PCR kit, Roche cobas® EGFR Mutation Test or a sponsor-approved laboratory developed test that is validated in a CLIA laboratory (with tissue submitted for central laboratory confirmation via FDA approved QIAGEN therascreen RCQ PCR kit). 2. T790M disease as follows: Phase 1 If a repeat biopsy was performed on the tumor following prior EGFR TKI therapy, then T790M positive disease must be present. Patients of unknown T790M status following EGFR TKI progression (ie, no post EGFR TKI progression biopsy was performed) are eligible. In the PK sub-studies involving food/antacid and CYP3A4 effects, patients with EGFRm (del 19 or L858R) with any T790M status are eligible to enroll. Studies at RP2D Cohort 1: Patients may have de novo T790M mutation, but it is not required. Cohort 2 and Cohort 3: Patients must have EGRFm (del 19 AND T790M or L858R AND T790M) NSCLC tumors as detected by local EGFR mutation test that includes QIAGEN Therascreen EGFR RGQ PCR kit, Roche cobas® EGFR Mutation Test or a sponsor-approved laboratory developed test that is validated in a CLIA laboratory, which will then be retrospectively confirmed by the central validated Thermo Fisher Scientific Oncomine Next Generation Sequencing (NGS) cancer panel test. Patients will also be enrolled if they solely test positive for EGFR (del 19 AND T790M or L858R AND T790M) NSCLC in plasma detected by local EGFR mutation test that includes QIAGEN Therascreen EGFR Plasma RGQ kit, Roche cobas® EGFR mutation test v2 (US-IVD) or Sysmex Inostic's OncoBEAMTM EGFR test or a sponsor-approved laboratory developed test that is validated in a CLIA laboratory, which will then be retrospectively confirmed by a validated cfDNA test as determined by the Sponsor. 3. Prior treatment for EGFRm NSCLC as follows: Phase 1 Has progressed after at least 1 prior line of therapy including and EGFR TKI. Patients may have also received other lines of therapy before or after the EGFR TKI. Studies at RP2D Cohort 1: no prior treatment for locally advanced or metastatic EGFRm NSCLC. Cohorts 2 and 3: must have had disease progression on treatment with an approved 1st or 2nd generation EGFR TKI. Patients who have been treated with a 3rd generation EGFR TKI are ineligible for this study. Patients may have had multiple lines of therapy; however, the last therapy prior to study treatment must have been an approved EGFR TKI and received within 6 weeks prior to study registration. Patients must have at least one measurable lesion as defined by RECIST version 1.1 that has not been previously irradiated. Tumor tissue available. Requesting formalin fixed paraffin embedded (FFPE) block or 15 unstained sections (5 micron). If a lesser amount of tissue is available, contact the sponsor. An archival specimen is acceptable for Phase 1; a de novo specimen is required for Cohorts 2, and 3 if the T790M status was confirmed by tissue biopsy. Partial
Exclusion criteria
For All Phases/Cohorts Previously diagnosed brain metastases, unless the patient has completed the treatment that is clinically indicated, if any, and has recovered from the acute effects of any treatment that was delivered prior to study registration, have discontinued corticosteroid treatment for these metastases prior to registration, and are neurologically stable. Major surgery within 2 weeks prior to registration. Radiation therapy, excluding stereotactic radiosurgery (SRS), within 1 week prior to registration. Systemic anti cancer therapy within 2 weeks or 5 half-lives (whichever is longer) of registration excluding EGFR TKIs. Patients on EGFR TKIs must discontinue the agent for a minimum of: * 2 days prior to registration for erlotinib or afatinib, or 3 days for gefitinib if they will be part of the lead-in single dose PF-06747775 PK study (Phase 1 Dose Escalation Single and Multiple dose PK and ECG Assessments; Phase 1 Sildenafil at MTD; and Phase 1b/2 First-Line Single Agent). Please contact the Sponsor for direction for any other EGFR TKI. * 5 half-lives or 5 days (whichever is longer) prior to registration if they will be starting on continuous PF-06747775 dosing directly (Phase 1 PK sub-studies at RP2D; Phase 1b/2 Combination with Palbociclib; Phase 1b Combination with Avelumab). Partial Exclusions for Cohort 2A and 2B (Palbociclib combo): Prior treatment with a CDK 4/6 inhibitor. Partial Exclusions for Cohort 3 (Avelumab combo): Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab, tremelimumab or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways). Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible Use of immunosuppressive medication at time of randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 21 days for Phase 1 dose-escalation cohorts and Japan LIC; 42 days for Phase 1b Cohort 2A; 28 days for Phase 1b Cohort 3 | DLT was defined as any of the following adverse events (AEs) occurring during the first cycle for Phase 1 dose-escalation cohorts, Japan LIC and Phase 1b Cohort 3, or the first 2 cycles for Phase 1b Cohort 2A of treatment, and considered attributable to study intervention: Grade 4 neutropenia \>7 days; febrile neutropenia; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade \>=3 non-hematologic toxicities; Grade 4 rash, mucositis, or diarrhea; failure to receive at least 70% of planned doses; Grade 3 QTcF prolongation in asymptomatic participants; treatment-related AEs attributable to PF-06747775, palbociclib or both that caused palbociclib treatment delay \>= 10 days or omission of at least 12 doses of the combination. Grade of AE was defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. |
| Number of Participants With Confirmed Objective Response (OR) in PF-06747775 200 mg QD Group | Baseline up to end of treatment (maximum of 165 weeks) | Number of participants with confirmed OR according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. Complete response (CR) was defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. |
| Progression-free Survival (PFS) in Phase 2 Cohort 2B | Cycle 1 Day 1 up to the end of study (maximum of 5 years) | PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective progression (PD) or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Baseline up to the end of treatment (maximum of 195 weeks) | Laboratory values included hemoglobin, platelets, white blood cell count (WBC), absolute (abs) neutrophils, abs lymphocytes, abs monocytes, abs eosinophils, abs basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (Alk Phos), sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate, prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT), urinalysis and pregnancy test. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. |
| Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | Baseline up to Cycle 4 Day 1 (maximum of 10 weeks) | Number of participants meeting categorical criteria of QTcF values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcF within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcF were defined as: maximum values 450 - \<480 msec, 480 - \<500 msec and \>=500 msec. |
| Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | Baseline up to Cycle 4 Day 1 (maximum of 10 weeks) | Number of participants meeting categorical criteria of QTcB values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcB within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcB were defined as: maximum values 450 - \<480 msec, 480 - \<500 msec and \>=500 msec. |
| Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Baseline up to end of treatment (maximum of 195 weeks) | Number of participants in Phase 1 cohorts with confirmed and unconfirmed OR according to RECIST v1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. Indeterminate was defined as progression not documented. |
| Objective Response Rate (ORR) in Phase 1b/2 Cohorts 2A, 2B and 3 | Baseline up to end of treatment (maximum of 108 weeks) | ORR was defined as percentage of participants with OR based assessment of CR or PR according to RECIST v1.1 that must have been confirmed ≥4 weeks later. Participants who did not have an on treatment radiographic tumor assessment due to early progression, who received anti tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non responders in the assessment of ORR. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. |
| PFS in PF-06747775 200 mg QD Group, Phase 1b Cohorts 2A and 3 | Cycle 1 Day 1 up to the end of study (maximum of 5 years) | PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. |
| Duration of Objective Response (DOR) in Phase 1b/2 Cohorts | Baseline up to the end of study (maximum of 5 years) | DOR was the time from the date of first documentation of confirmed CR or PR to the date of first documentation of PD or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DOR (months) = \[progression/death date - first date of OR + 1\]/30.4. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. |
| Overall Survival (OS) Probability at 12 Months in Phase 1b/2 Cohorts | Baseline up to the end of study (maximum of 5 years) | OS probability was based on Kaplan-Meier method. OS was defined as the time from the start date to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. |
| Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1 | Plasma area under the curve from zero to infinite time (AUCinf) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1 | Cmax of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. Cmax was the maximum concentration after dose administration observed directly from the data. |
| Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1 | Half-life (t1/2) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. t1/2 was defined as the time measured for the plasma concentration to decrease by one half. |
| Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1 | Apparent clearance (CL/F) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1 | Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf \* kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | Pre-dose on Cycle 1 Day 11 | Pre-dose concentration at steady state (Ctrough) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data. |
| Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose on Cycle 1 Day 11 for Phase 2 Cohorts 1 and 2B | AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose for Phase 2 Cohorts 1 and 2B | CL/F of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11 for dose-escalation cohorts, Cohorts 1 and 2B | Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours. |
| Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1, 2, 4, 6, 8, 24, 48 and 72 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or Day -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11 | Steady state accumulation ratio (Rss) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| AUCinf of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Day -8 (+/- 3 days) in lead-in period | AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time. |
| Cmax of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in period | Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure. Cmax was the maximum concentration after dose administration observed directly from the data. |
| CL/F of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in period | CL/F of sildenafil dosed alone on Day -8 lead-in period in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| AUCinf of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days) | AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time. |
| Cmax of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days) | Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure. |
| CL/F of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days) | CL/F of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period and Cycle 1 Day 11 in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| AUCtau of PF-06747775 at RP2D Under Fed and Overnight Fasted Conditions in Phase 1 Food Effect and Rifampin DDI Sub-study | Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9 | AUCtau of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Cmax of PF-06747775 at RP2D Under Fed and Overnight Fasted Conditions in Phase 1 Food Effect and Rifampin DDI Sub-study | Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9 | Cmax of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data. |
| AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21 | AUCtau of PF-06747775 at the RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21 | Cmax of PF-06747775 at RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data. |
| AUCtau of PF-06747775 at RP2D Dosed Alone and After Rifampin Treatment in Phase 1 Food Effect and Rifampin DDI Sub-study | Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21 | AUCtau of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Cmax of PF-06747775 at RP2D Dosed Alone and After Rifampin Treatment in Phase 1 Food Effect and Rifampin DDI Sub-study | Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21 | Cmax of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data. |
| AUCtau of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15 | AUCtau of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Cmax of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15 | Cmax of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data. |
| CL/F of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15 | CL/F of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 | Ctrough of PF-06747775 following multiple doses when given in combination with palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data. |
| Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Avelumab on Cycle 1 Day 15 in Phase 1b Cohort 3 | Pre-dose on Cycle 1 Day 15 | Ctrough of PF-06747775 following multiple doses when given in combination with avelumab on Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data. |
| AUCtau of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15 | AUCtau of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Cmax of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15 | Cmax of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data. |
| Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 | Ctrough of palbociclib following multiple doses when given in combination with PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b/2 Cohorts 2A and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data. |
| Ctrough of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15 | Ctrough of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data. |
| Cmax of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | End of infusion of avelumab on Day 1 of Cycles 1-3 and Cycle 1 Day 15 | Cmax of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Cmax was the end of infusion peak concentration observed directly from data. |
| Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | Baseline | Number of participants with EGFR mutations in tumor tissue in all cohorts all phases. EGFR mutation assessments in tumor tissue included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R), G719X, L861Q, S768I, exon 20 insertions and T790M. |
| Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | Baseline | Number of participants with EGFR mutations in plasma in all cohorts all phases. EGFR mutation assessments in plasma included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R) and T790M. |
| Number of Participants With Positive Serum Anti-drug Antibody (ADA) of Avelumab in Phase 1b Cohort 3 | Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15 | Number of participants with positive serum ADA of avelumab at pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. |
| AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort | AUCinf of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time. |
| Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort | Cmax of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Cmax was the maximum concentration observed from data. |
| Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort | Vz/F of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf \* kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort | t1/2 of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. t1/2 was defined as the time measured for the plasma concentration to decrease by one half. |
| Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks) | AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. |
| Ctrough of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | Pre-dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort) | Ctrough of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data. |
| Rac of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohort | Rac of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours following single dose. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. |
| Rss of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohort | Rss of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan RP2D cohort and Cycle 1 Day 15 in Japan PK cohort. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Lead-in Day-7, Days 1 and 15 for Japan LIC PK cohort | CL/F of PF-06747775 following single dose on Lead-in Day -4 in Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK cohort, and following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and on Cycle 1 Day 15 in Japan LIC PK cohort. CL/F was calculated as: CL/F = dose/AUCinf for single dose or dose/AUCtau for multiple doses. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time. |
| AUCtau of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort) | AUCtau of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. |
| Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks) | Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Treatment-related AEs were determined by the investigator. |
| Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks) | An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related SAEs were determined by the investigator. |
Countries
Australia, Japan, South Korea, United States
Participant flow
Pre-assignment details
A total of 65 participants were enrolled, assigned to study treatment and treated in the study. The study was prematurely terminated by sponsor due to an internal strategic decision and changes in the external environment. No safety concerns were related to the study termination. No enrollments occurred in Phase 1 Food Effect and Rifampin Drug-Drug Interaction (DDI) sub-study, Phase 2 Cohort 2B or Phase 1b Cohort 3 prior to study termination.
Participants by arm
| Arm | Count |
|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD Participants received a single oral dose of PF-06747775 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 25 mg once daily (QD) for 21-day cycles (up to a maximum of 95 weeks). | 4 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD Participants received a single oral dose of PF-06747775 50 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 50 mg QD for 21-day cycles (up to a maximum of 72 weeks). | 3 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD Participants received a single oral dose of PF-06747775 150 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 150 mg QD for 21-day cycles (up to a maximum of 54 weeks). | 4 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD Participants received a single oral dose of PF-06747775 275 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 275 mg QD for 21-day cycles (up to a maximum of 128 weeks). | 4 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD Participants received a single oral dose of PF-06747775 300 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 188 weeks). | 3 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD Participants received a single oral dose of PF-06747775 450 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 450 mg QD for 21-day cycles (up to a maximum of 195 weeks). | 4 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD Participants received a single oral dose of PF-06747775 600 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 600 mg QD for 21-day cycles (up to a maximum of 182 weeks). | 4 |
| PF-06747775 200 mg QD Group Participants received a single oral dose of PF-06747775 200 mg on Day -4 in lead-in period, followed by continuous oral dosing of PF-06747775 200 mg QD for 21-day cycles (up to a maximum of 165 weeks). PF-06747775 200 mg QD group was a combined group of PF-06747775 200 mg QD + sildenafil 25 mg SD (Phase 1 Sildenafil sub-study), PF-06747775 200 mg QD + esomeprazole/itraconazole (Phase 1 Esomeprazole/Itraconazole sub-study), Japan Lead-in cohort (LIC) and Phase 2 Cohort 1. | 29 |
| Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD Participants received a single oral dose of sildenafil 25 mg on Day -8 (+/- 3 days) in lead-in period, followed by continuous oral dosing of PF-06747775 300 mg QD for 21-day cycles (up to a maximum of 121 weeks) plus a single oral dose of sildenafil 25 mg on Cycle 1 Day 11. | 5 |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD Participants received continuous oral dosing of PF-06747775 200 mg QD plus palbociclib 100 mg QD for 21-day cycles (up to a maximum of 102 weeks). | 5 |
| Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin Participants were planned to receive continuous oral dosing of PF-06747775 at Recommended Phase 2 Dose (RP2D) QD for a 21-day cycles plus rifampin 600 mg QD through Day 10 to 21 of Cycle 1. No participants were enrolled or treated in this cohort prior to study termination. | 0 |
| Phase 2 Cohort 2B: PF-06747775 + Palbociclib Participants were planned to receive continuous oral dosing of PF-06747775 QD and palbociclib QD at RP2D for 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination. | 0 |
| Phase 2 Cohort 2B: PF-06747775 Single Agent Participants were planned to received continuous oral dosing of PF-06747775 QD at RP2D for a 21-day cycles. No participants were enrolled or treated in this cohort prior to study termination. | 0 |
| Phase 1b Cohort 3: PF-06747775 + Avelumab Participants were planned to receive continuous oral dosing of PF-06747775 at RP2D QD for 28-day cycles plus intravenous dosing of avelumab 10 mg/kg every 2 weeks (Q2W) on Days 1 and 15 of each cycle. No participants were enrolled or treated in this cohort prior to study termination. | 0 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Early termination of survival follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 4 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Termination by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 2 | 0 | 0 | 0 | 0 |
| Overall Study | Transition to compassionate use | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 3 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 2 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal of informed consent | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Phase 1 Dose-escalation: PF-06747775 50 mg QD | Phase 1 Dose-escalation: PF-06747775 25 mg QD | Phase 1 Dose-escalation: PF-06747775 150 mg QD | Phase 1 Dose-escalation: PF-06747775 275 mg QD | Phase 1 Dose-escalation: PF-06747775 300 mg QD | Phase 1 Dose-escalation: PF-06747775 450 mg QD | Phase 1 Dose-escalation: PF-06747775 600 mg QD | PF-06747775 200 mg QD Group | Phase 1 Sildenafil Sub-study: PF-06747775 300 mg QD + Sildenafil 25 mg SD | Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Total | Phase 1b Cohort 3: PF-06747775 + Avelumab | Phase 1 Food Effect and Rifampin DDI Sub-study: PF-06747775 + Rifampin | Phase 2 Cohort 2B: PF-06747775 + Palbociclib | Phase 2 Cohort 2B: PF-06747775 Single Agent |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 72.0 Years | 70.5 Years | 62.0 Years | 60.3 Years | 55.7 Years | 63.5 Years | 61.0 Years | 58.8 Years | 63.6 Years | 55.0 Years | 60.8 Years | — | — | — | — |
| Primary Diagnoses and Durations Adenocarcinoma | 0.0 Years | 0.0 Years | 5.8 Years | 3.2 Years | 0.0 Years | 0.0 Years | 1.5 Years | 0.2 Years | 0.0 Years | 0.0 Years | 1.5 Years | — | — | — | — |
| Primary Diagnoses and Durations Adenocarcinoma metastatic | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 2.1 Years | 2.1 Years | — | — | — | — |
| Primary Diagnoses and Durations Lung adenocarcinoma | 9.3 Years | 0.0 Years | 3.6 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 1.2 Years | 0.0 Years | 0.9 Years | 2.7 Years | — | — | — | — |
| Primary Diagnoses and Durations Lung adenocarcinoma stage IV | 3.4 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 3.4 Years | — | — | — | — |
| Primary Diagnoses and Durations Lung neoplasm malignant | 0.0 Years | 3.6 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.9 Years | 5.1 Years | 4.9 Years | 0.0 Years | 3.4 Years | — | — | — | — |
| Primary Diagnoses and Durations Non-small cell lung cancer | 0.0 Years | 0.7 Years | 0.0 Years | 2.0 Years | 1.0 Years | 2.3 Years | 3.4 Years | 1.7 Years | 2.9 Years | 2.6 Years | 1.8 Years | — | — | — | — |
| Primary Diagnoses and Durations Non-small cell lung cancer stage IV | 0.0 Years | 0.0 Years | 4.6 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 4.6 Years | — | — | — | — |
| Primary Diagnoses and Durations Squamous cell carcinoma | 0.8 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.0 Years | 0.8 Years | — | — | — | — |
| Race/Ethnicity, Customized Asian | 1 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 24 Participants | 4 Participants | 3 Participants | 47 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Unspecified | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 16 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 2 Participants | 3 Participants | 3 Participants | 4 Participants | 0 Participants | 0 Participants | 3 Participants | 19 Participants | 3 Participants | 3 Participants | 40 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 4 Participants | 1 Participants | 10 Participants | 2 Participants | 2 Participants | 25 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 1 / 3 | 0 / 4 | 0 / 4 | 0 / 3 | 1 / 4 | 1 / 4 | 0 / 29 | 0 / 5 | 0 / 5 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 4 / 4 | 3 / 3 | 4 / 4 | 4 / 4 | 3 / 3 | 4 / 4 | 4 / 4 | 29 / 29 | 5 / 5 | 5 / 5 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 2 / 4 | 1 / 3 | 3 / 4 | 3 / 4 | 0 / 3 | 3 / 4 | 2 / 4 | 3 / 29 | 0 / 5 | 1 / 5 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Number of Participants With Confirmed Objective Response (OR) in PF-06747775 200 mg QD Group
Number of participants with confirmed OR according to Response Evaluation Criteria in Solid Tumor (RECIST) v1.1. Complete response (CR) was defined as complete disappearance of all target lesions with the exception of nodal disease. Partial response (PR) was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Time frame: Baseline up to end of treatment (maximum of 165 weeks)
Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Confirmed Objective Response (OR) in PF-06747775 200 mg QD Group | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Confirmed Objective Response (OR) in PF-06747775 200 mg QD Group | PR | 11 Participants |
Primary
Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A
DLT was defined as any of the following adverse events (AEs) occurring during the first cycle for Phase 1 dose-escalation cohorts, Japan LIC and Phase 1b Cohort 3, or the first 2 cycles for Phase 1b Cohort 2A of treatment, and considered attributable to study intervention: Grade 4 neutropenia \>7 days; febrile neutropenia; Grade \>=3 thrombocytopenia with bleeding; Grade 4 thrombocytopenia; Grade \>=3 non-hematologic toxicities; Grade 4 rash, mucositis, or diarrhea; failure to receive at least 70% of planned doses; Grade 3 QTcF prolongation in asymptomatic participants; treatment-related AEs attributable to PF-06747775, palbociclib or both that caused palbociclib treatment delay \>= 10 days or omission of at least 12 doses of the combination. Grade of AE was defined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time frame: 21 days for Phase 1 dose-escalation cohorts and Japan LIC; 42 days for Phase 1b Cohort 2A; 28 days for Phase 1b Cohort 3
Population: The analysis population included participants in Phase 1 dose-escalation cohorts, Japan LIC, Phase 1b Cohorts 2A and 3 who were eligible, received study treatment and who either experienced a DLT during the first cycle of PF-06747775 or the first 2 cycles of PF 06747775 plus palbociclib, or completed the DLT observation period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Japan LIC | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Dose Limiting Toxicities (DLTs) During the First Cycle in Phase 1 Dose-escalation Cohorts, Japan LIC and Phase 1b Cohort 3, and First 2 Cycles in Phase 1b Cohort 2A | 2 Participants |
Primary
Progression-free Survival (PFS) in Phase 2 Cohort 2B
PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of objective progression (PD) or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time frame: Cycle 1 Day 1 up to the end of study (maximum of 5 years)
Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
Secondary
Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
Apparent clearance (CL/F) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 15.43 L/hr | Geometric Coefficient of Variation 32 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 15.64 L/hr | Geometric Coefficient of Variation 34 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 15.72 L/hr | Geometric Coefficient of Variation 45 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 11.41 L/hr | Geometric Coefficient of Variation 23 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 14.19 L/hr | Geometric Coefficient of Variation 28 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 9.756 L/hr | Geometric Coefficient of Variation 60 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 14.09 L/hr | Geometric Coefficient of Variation 25 |
| Japan LIC | Apparent Clearance (CL/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | NA L/hr | — |
Secondary
Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose on Cycle 1 Day 11 for Phase 2 Cohorts 1 and 2B
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 2067 ng*hr/mL | Geometric Coefficient of Variation 33 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 3605 ng*hr/mL | Geometric Coefficient of Variation 60 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 14830 ng*hr/mL | Geometric Coefficient of Variation 74 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 31490 ng*hr/mL | Geometric Coefficient of Variation 48 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 21500 ng*hr/mL | Geometric Coefficient of Variation 28 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 40770 ng*hr/mL | Geometric Coefficient of Variation 36 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 43060 ng*hr/mL | Geometric Coefficient of Variation 56 |
| Japan LIC | Area Under the Curve at Steady State (AUCtau) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 19990 ng*hr/mL | Geometric Coefficient of Variation 122 |
Secondary
AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
AUCinf of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 13610 ng*hr/mL | Geometric Coefficient of Variation 39 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 16060 ng*hr/mL | Geometric Coefficient of Variation 4 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | AUCinf of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 100 mg SD | 6880 ng*hr/mL | Geometric Coefficient of Variation 23 |
Secondary
AUCinf of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study
AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time.
Time frame: 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Day -8 (+/- 3 days) in lead-in period
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCinf of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 757.7 ng*hr/mL | Geometric Coefficient of Variation 61 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | AUCinf of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 459.1 ng*hr/mL | Geometric Coefficient of Variation 41 |
Secondary
AUCinf of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study
AUCinf of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period in Phase 1 Sildenafil sub-study. AUCinf was defined as area under the plasma concentration versus time curve from zero to extrapolated infinite time.
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCinf of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 429.1 ng*hr/mL | Geometric Coefficient of Variation 84 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | AUCinf of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 298.3 ng*hr/mL | Geometric Coefficient of Variation 39 |
Secondary
AUCtau of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
AUCtau of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCtau of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 1420 ng*hr/mL | Geometric Coefficient of Variation 42 |
Secondary
AUCtau of PF-06747775 at RP2D Dosed Alone and After Rifampin Treatment in Phase 1 Food Effect and Rifampin DDI Sub-study
AUCtau of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Secondary
AUCtau of PF-06747775 at RP2D Under Fed and Overnight Fasted Conditions in Phase 1 Food Effect and Rifampin DDI Sub-study
AUCtau of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Secondary
AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
AUCtau of PF-06747775 at the RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | Cycle 1 Day 8 | 17200 ng*hr/mL | Geometric Coefficient of Variation 45 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | Cycle 1 Day 13 | 14340 ng*hr/mL | Geometric Coefficient of Variation 35 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCtau of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | Cycle 1 Day 21 | 10010 ng*hr/mL | Geometric Coefficient of Variation 54 |
Secondary
AUCtau of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
AUCtau of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort)
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCtau of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 17680 ng*hr/mL | Geometric Coefficient of Variation 35 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | AUCtau of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 23300 ng*hr/mL | Geometric Coefficient of Variation 32 |
Secondary
AUCtau of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
AUCtau of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | AUCtau of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 17040 ng*hr/mL | Geometric Coefficient of Variation 91 |
Secondary
CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
CL/F of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8, 24 hours post-dose on Cycle 1 Day 11 for Phase 1 dose-escalation cohorts; 0 (pre-dose), 1, 2, 4, 6, 24 hours post-dose for Phase 2 Cohorts 1 and 2B
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 12.11 L/hr | Geometric Coefficient of Variation 33 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 13.85 L/hr | Geometric Coefficient of Variation 60 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 10.11 L/hr | Geometric Coefficient of Variation 74 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 8.737 L/hr | Geometric Coefficient of Variation 48 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 13.92 L/hr | Geometric Coefficient of Variation 28 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 11.03 L/hr | Geometric Coefficient of Variation 35 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 12.97 L/hr | Geometric Coefficient of Variation 42 |
| Japan LIC | CL/F of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 10.01 L/hr | Geometric Coefficient of Variation 123 |
Secondary
CL/F of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
CL/F of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. CL/F was calculated as: CL/F = dose / AUCtau. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method.
Time frame: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | CL/F of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 11.74 L/hr | Geometric Coefficient of Variation 91 |
Secondary
CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts
CL/F of PF-06747775 following single dose on Lead-in Day -4 in Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK cohort, and following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and on Cycle 1 Day 15 in Japan LIC PK cohort. CL/F was calculated as: CL/F = dose/AUCinf for single dose or dose/AUCtau for multiple doses. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Lead-in Day-7, Days 1 and 15 for Japan LIC PK cohort
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts | PF-06747775 200 mg QD | 11.32 L/hr | Geometric Coefficient of Variation 35 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts | PF-06747775 200 mg SD | 14.64 L/hr | Geometric Coefficient of Variation 40 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts | PF-06747775 200 mg QD | 8.594 L/hr | Geometric Coefficient of Variation 32 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts | PF-06747775 200 mg SD | 12.46 L/hr | Geometric Coefficient of Variation 4 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | CL/F of PF-06747775 Following Single and Multiple Doses in Japan LIC RP2D and PK Cohorts | PF-06747775 100 mg SD | 14.57 L/hr | Geometric Coefficient of Variation 24 |
Secondary
CL/F of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study
CL/F of sildenafil dosed alone on Day -8 lead-in period in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in period
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | CL/F of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 33.03 L/hr | Geometric Coefficient of Variation 61 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | CL/F of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 54.39 L/hr | Geometric Coefficient of Variation 41 |
Secondary
CL/F of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study
CL/F of sildenafil dosed alone and in combination with PF-06747775 200 mg or 300 mg on Day -8 lead-in period and Cycle 1 Day 11 in Phase 1 Sildenafil sub-study. CL/F was calculated as: CL/F = dose / AUCinf. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | CL/F of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 58.20 L/hr | Geometric Coefficient of Variation 84 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | CL/F of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 83.88 L/hr | Geometric Coefficient of Variation 40 |
Secondary
Cmax of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3
Cmax of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Cmax was the end of infusion peak concentration observed directly from data.
Time frame: End of infusion of avelumab on Day 1 of Cycles 1-3 and Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Cmax of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 1 Day 1 | — |
| Unknown | Cmax of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 1 Day 15 | — |
| Unknown | Cmax of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 2 Day 1 | — |
| Unknown | Cmax of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 3 Day 1 | — |
Secondary
Cmax of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cmax of palbociclib following multiple doses when given in combination with PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 78.93 ng/mL | Geometric Coefficient of Variation 39 |
Secondary
Cmax of PF-06747775 at RP2D Dosed Alone and After Rifampin Treatment in Phase 1 Food Effect and Rifampin DDI Sub-study
Cmax of PF-06747775 at RP2D dosed alone and after rifampin treatment in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Day 21
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Secondary
Cmax of PF-06747775 at RP2D Under Fed and Overnight Fasted Conditions in Phase 1 Food Effect and Rifampin DDI Sub-study
Cmax of PF-06747775 at the RP2D under fed and overnight fasted conditions in Phase 1 Food Effect and Rifampin DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: Pre-dose, 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8 and 9
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Secondary
Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study
Cmax of PF-06747775 at RP2D when dosed alone and after esomeprazole/itraconazole treatment in Phase 1 Esomeprazole-Itraconazole DDI sub-study. Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose of PF-06747775 on Cycle 1 Days 8, 13 and 21
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | Cycle 1 Day 8 | 2597 ng/mL | Geometric Coefficient of Variation 46 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | Cycle 1 Day 13 | 2015 ng/mL | Geometric Coefficient of Variation 37 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of PF-06747775 at RP2D When Dosed Alone and After Esomeprazole/Itraconazole Treatment in Phase 1 Esomeprazole-Itraconazole DDI Sub-study | Cycle 1 Day 21 | 1592 ng/mL | Geometric Coefficient of Variation 68 |
Secondary
Cmax of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Cmax of PF-06747775 following multiple doses when given in combination with palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: 0 (pre-dose), 1, 2, 4, 6 and 24 hours post dose on Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Cycle 1 Day 15 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | 2757 ng/mL | Geometric Coefficient of Variation 87 |
Secondary
Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
Cmax of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Cmax was the maximum concentration observed from data.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 3128 ng/mL | Geometric Coefficient of Variation 22 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 2795 ng/mL | Geometric Coefficient of Variation 36 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Cmax of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 100 mg SD | 1407 ng/mL | Geometric Coefficient of Variation 26 |
Secondary
Cmax of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study
Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure. Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post dose on Day -8 (+/- 3 days) in lead-in period
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 182.5 ng/mL | Geometric Coefficient of Variation 80 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Cmax of Sildenafil Dosed Alone on Day -8 lead-in Period in Phase 1 Sildenafil Sub-study | 148.4 ng/mL | Geometric Coefficient of Variation 46 |
Secondary
Cmax of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study
Cmax values for sildenafil were analyzed using a mixed effects model with treatment as fixed effect and participant as random effect to estimate the effect of steady state PF-06747775 on sildenafil exposure.
Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8 and 24 hours post-dose on Cycle 1 Day 11 (+/- 4 days)
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Cmax of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 204.5 ng/mL | Geometric Coefficient of Variation 67 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Cmax of Sildenafil Dosed in Combination With PF-06747775 200 mg or 300 mg on Cycle 1 Day 11 in Phase 1 Sildenafil Sub-study | 87.57 ng/mL | Geometric Coefficient of Variation 29 |
Secondary
Ctrough of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3
Ctrough of avelumab when given in combination with PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Time frame: Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Ctrough of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 1 Day 1 | — |
| Unknown | Ctrough of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 1 Day 15 | — |
| Unknown | Ctrough of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 2 Day 1 | — |
| Unknown | Ctrough of Avelumab When Given in Combination With PF-06747775 on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3 | Cycle 3 Day 1 | — |
Secondary
Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Ctrough of palbociclib following multiple doses when given in combination with PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b/2 Cohorts 2A and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Time frame: Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 1 Day 15 | 40.46 ng/mL | Geometric Coefficient of Variation 59 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 2 Day 1 | 28.83 ng/mL | Geometric Coefficient of Variation 57 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 2 Day 15 | 32.80 ng/mL | Geometric Coefficient of Variation 42 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 3 Day 1 | 23.82 ng/mL | Geometric Coefficient of Variation 34 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of Palbociclib Following Multiple Doses When Given in Combination With PF-06747775 on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 4 Day 1 | 25.85 ng/mL | Geometric Coefficient of Variation 54 |
Secondary
Ctrough of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
Ctrough of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Time frame: Pre-dose on Cycle 1 Day 11 (Japan LIC RP2D cohort) and Day 15 (Japan LIC PK cohort)
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 48.91 ng/mL | Geometric Coefficient of Variation 14 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Ctrough of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 79.75 ng/mL | Geometric Coefficient of Variation 91 |
Secondary
Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Avelumab on Cycle 1 Day 15 in Phase 1b Cohort 3
Ctrough of PF-06747775 following multiple doses when given in combination with avelumab on Cycle 1 Day 15 in Phase 1b Cohort 3. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Time frame: Pre-dose on Cycle 1 Day 15
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
Secondary
Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B
Ctrough of PF-06747775 following multiple doses when given in combination with palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Time frame: Pre-dose on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 1 Day 15 | 57.73 ng/mL | Geometric Coefficient of Variation 91 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 2 Day 1 | 29.44 ng/mL | Geometric Coefficient of Variation 58 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 2 Day 15 | 48.39 ng/mL | Geometric Coefficient of Variation 30 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 3 Day 1 | 42.68 ng/mL | Geometric Coefficient of Variation 56 |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Ctrough of PF-06747775 Following Multiple Doses When Given in Combination With Palbociclib on Day 15 of Cycles 1-2 and Day 1 of Cycles 2-4 in Phase 1b Cohort 2A and Phase 2 Cohort 2B | Cycle 4 Day 1 | 35.12 ng/mL | Geometric Coefficient of Variation 38 |
Secondary
Duration of Objective Response (DOR) in Phase 1b/2 Cohorts
DOR was the time from the date of first documentation of confirmed CR or PR to the date of first documentation of PD or death due to any cause. If tumor progression data included more than 1 date, the first date was used. DOR (months) = \[progression/death date - first date of OR + 1\]/30.4. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time frame: Baseline up to the end of study (maximum of 5 years)
Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Duration of Objective Response (DOR) in Phase 1b/2 Cohorts | 8.322 Months |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Duration of Objective Response (DOR) in Phase 1b/2 Cohorts | 11.069 Months |
Secondary
Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
Half-life (t1/2) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. t1/2 was defined as the time measured for the plasma concentration to decrease by one half.
Time frame: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 13.12 hrs | Standard Deviation 9.615 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 12.97 hrs | Standard Deviation 7.921 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 6.870 hrs | Standard Deviation 1.972 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 9.907 hrs | Standard Deviation 10.304 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 4.113 hrs | Standard Deviation 0.611 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 9.453 hrs | Standard Deviation 9.654 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 6.213 hrs | Standard Deviation 3.466 |
| Japan LIC | Half-life (t1/2) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | NA hrs | — |
Secondary
Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
Cmax of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. Cmax was the maximum concentration after dose administration observed directly from the data.
Time frame: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 369.3 ng/mL | Geometric Coefficient of Variation 55 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 570.6 ng/mL | Geometric Coefficient of Variation 14 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 2242 ng/mL | Geometric Coefficient of Variation 29 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 3599 ng/mL | Geometric Coefficient of Variation 13 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 3205 ng/mL | Geometric Coefficient of Variation 19 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 5556 ng/mL | Geometric Coefficient of Variation 27 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 6517 ng/mL | Geometric Coefficient of Variation 12 |
| Japan LIC | Maximum Concentration Observed After Dose Administration (Cmax) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 2829 ng/mL | Geometric Coefficient of Variation 132 |
Secondary
Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
Number of participants meeting categorical criteria of QTcB values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcB within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcB were defined as: maximum values 450 - \<480 msec, 480 - \<500 msec and \>=500 msec.
Time frame: Baseline up to Cycle 4 Day 1 (maximum of 10 weeks)
Population: QTcB analysis population included all treated participants who had at least 1 ECG assessment undertaken pre dose and 1 post dose at steady state in triplicate.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 1 Participants |
| Japan LIC | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 1 Participants |
| Japan LIC | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Japan LIC | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants Meeting Categorical Criteria of QTcB Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 1 Participants |
Secondary
Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab.
Number of participants meeting categorical criteria of QTcF values when PF-06747775 was given as a single agent in Phase 1 dose-escalation cohorts, PF-06747775 200 mg QD group (only participants in Phase 2 Cohort 1 and Japan LIC were eligible for QTcF within this combined group), and in combination with palbociclib and avelumab in Phase 1b/2 Cohorts 2A, 2B and 3. Criteria for categorization of QTcF were defined as: maximum values 450 - \<480 msec, 480 - \<500 msec and \>=500 msec.
Time frame: Baseline up to Cycle 4 Day 1 (maximum of 10 weeks)
Population: QTcF analysis population included all treated participants who had at least 1 ECG assessment undertaken pre dose and 1 post dose at steady state in triplicate.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 1 Participants |
| Japan LIC | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 1 Participants |
| Japan LIC | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
| Japan LIC | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 480 msec - <500 msec | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | 450 msec - <480 msec | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants Meeting Categorical Criteria of QTcF Values When PF-06747775 Was Given as a Single Agent, and in Combination With Palbociclib and Avelumab. | >=500 msec | 0 Participants |
Secondary
Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts
Number of participants in Phase 1 cohorts with confirmed and unconfirmed OR according to RECIST v1.1. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Stable was defined as not qualifying for CR, PR or PD. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. Indeterminate was defined as progression not documented.
Time frame: Baseline up to end of treatment (maximum of 195 weeks)
Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 0 Participants |
| Japan LIC | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Stable / No response | 1 Participants |
| Japan LIC | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | CR | 0 Participants |
| Japan LIC | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PR | 3 Participants |
| Japan LIC | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | Indeterminate | 0 Participants |
| Japan LIC | Number of Participants With Confirmed and Unconfirmed OR in Phase 1 Cohorts | PD | 1 Participants |
Secondary
Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases
Number of participants with EGFR mutations in plasma in all cohorts all phases. EGFR mutation assessments in plasma included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R) and T790M.
Time frame: Baseline
Population: The biomarker analysis set is defined as all participants in the safety analysis set who had at least one screening and post treatment biomarker assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 29 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 8 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 2 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 19 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 3 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 28 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 27 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 26 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 2 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 26 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 10 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 22 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 6 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Japan LIC | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 21 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 5 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 5 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 5 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 1 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 5 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 5 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 4 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 4 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Positive | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Positive | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Negative | 4 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Negative | 5 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Negative | 5 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Positive | 3 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2235_49DEL15) | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Negative | 5 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Negative | 5 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2239_48DELINSC) | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | T790M | Negative | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_54DEL15) | Negative | 5 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2236_50DEL15) | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2237_55DELINST) | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | del 19 (2240_57DEL18) | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With EGFR Mutations in Plasma in All Cohorts All Phases | L858R | Negative | 3 Participants |
Secondary
Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases
Number of participants with EGFR mutations in tumor tissue in all cohorts all phases. EGFR mutation assessments in tumor tissue included the mutations statuses of exon 19 deletion (del 19), exon 21 (L858R), G719X, L861Q, S768I, exon 20 insertions and T790M.
Time frame: Baseline
Population: The biomarker analysis set is defined as all participants in the safety analysis set who had at least one screening and post treatment biomarker assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 2 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 10 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 17 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 16 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 2 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 9 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 2 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 26 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 2 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 26 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 26 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 2 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 26 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 1 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 2 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 19 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 7 Participants |
| Japan LIC | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 1 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 1 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Not done | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Negative | 4 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Negative | 3 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Not done | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Negative | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Positive | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Negative | 4 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Negative | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Negative | 4 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L861Q | Negative | 4 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Not done | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Not done | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | T790M | Positive | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Not done | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | exon 20 insertions | Not done | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | S768I | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Uninformative | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | G719X | Positive | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | del 19 | Positive | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Epidermal Growth Factor Receptor (EGFR) Mutations in Tumor Tissue in All Cohorts All Phases | L858R | Not done | 1 Participants |
Secondary
Number of Participants With Positive Serum Anti-drug Antibody (ADA) of Avelumab in Phase 1b Cohort 3
Number of participants with positive serum ADA of avelumab at pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15 in Phase 1b Cohort 3.
Time frame: Pre-dose on Day 1 of Cycles 1-3 and Cycle 1 Day 15
Population: The immunogenicity analysis set included participants who had at least one ADA sample collected for avelumab.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Number of Participants With Positive Serum Anti-drug Antibody (ADA) of Avelumab in Phase 1b Cohort 3 | Cycle 1 Day 1 | — |
| Unknown | Number of Participants With Positive Serum Anti-drug Antibody (ADA) of Avelumab in Phase 1b Cohort 3 | Cycle 1 Day 15 | — |
| Unknown | Number of Participants With Positive Serum Anti-drug Antibody (ADA) of Avelumab in Phase 1b Cohort 3 | Cycle 2 Day 1 | — |
| Unknown | Number of Participants With Positive Serum Anti-drug Antibody (ADA) of Avelumab in Phase 1b Cohort 3 | Cycle 3 Day 1 | — |
Secondary
Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-related SAEs were determined by the investigator.
Time frame: Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)
Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 1 Participants |
| Japan LIC | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 1 Participants |
| Japan LIC | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 3 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | Treatment-related SAEs | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Serious Adverse Events (SAEs) in All Cohorts All Phases | All-causality SAEs | 1 Participants |
Secondary
Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases
Laboratory values included hemoglobin, platelets, white blood cell count (WBC), absolute (abs) neutrophils, abs lymphocytes, abs monocytes, abs eosinophils, abs basophils, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (Alk Phos), sodium, potassium, magnesium, chloride, total calcium, total bilirubin, blood urea nitrogen (BUN) or urea, creatinine, uric acid, glucose, albumin, phosphorous or phosphate, prothrombin time (PT) or international normalized ratio (INR), partial thromboplastin time (PTT), urinalysis and pregnancy test. Grades of laboratory results were defined by NCI CTCAE version 4.03. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death.
Time frame: Baseline up to the end of treatment (maximum of 195 weeks)
Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 3 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 1 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Japan LIC | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 1 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 1 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 3) | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Total bilirubin (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyponatremia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphocyte count increased (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 3) | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypercalcemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoglycemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 3) | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hemoglobin increased (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Platelets (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypernatremia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 3) | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 3) | 2 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypophosphatemia (Grade 3) | 1 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Creatinine (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Lymphopenia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypomagnesemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | ALT (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperkalemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Alk Phos (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | WBC (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hyperglycemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypoalbuminemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypermagnesemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Abs neutrophils (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | AST (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypocalcemia (Grade 4) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Hypokalemia (Grade 3) | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Shifts of Laboratory Results From Grade <=2 at Baseline to Grade 3 or 4 Post-baseline in All Cohorts All Phases | Anemia (Grade 3) | 1 Participants |
Secondary
Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related)
Treatment-related AE was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Treatment-related AEs were determined by the investigator.
Time frame: Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)
Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Japan LIC | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 29 Participants |
| Japan LIC | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 7 Participants |
| Japan LIC | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 4 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 5 treatment-related AEs | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Treatment-related AEs | 5 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With TEAEs in All Cohorts All Phases (Treatment-related) | Grade 3 or 4 treatment-related AEs | 4 Participants |
Secondary
Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality)
AE = any untoward medical occurrence in participant who received study treatment without regard to possibility of causal relationship. Grade 3 (Severe) events = unacceptable or intolerable events, significantly interrupting usual daily activity, require systemic drug therapy/other treatment. Grade 4 (Life-threatening) events caused participant to be in imminent danger of death. Grade 5 (Death) events = death related to an AE. Treatment-emergent events = between first dose of study treatment and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time frame: Baseline up to 28 days after last dose of study treatment (maximum of 199 weeks)
Population: The safety analysis population included all enrolled participants who received at least one dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 0 Participants |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 2 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 3 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 1 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 4 Participants |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 1 Participants |
| Japan LIC | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 29 Participants |
| Japan LIC | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 0 Participants |
| Japan LIC | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 12 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 5 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 2 Participants |
| Phase 1b Cohort 2A: PF-06747775 200 mg QD + Palbociclib 100 mg QD | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 5 AEs | 0 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | Grade 3 or 4 AEs | 5 Participants |
| Phase 1b Cohort 3: PF-06747775 + Avelumab | Number of Participants With Treatment-emergent AEs (TEAEs) in All Cohorts All Phases (All-causality) | All-causality AEs | 5 Participants |
Secondary
Objective Response Rate (ORR) in Phase 1b/2 Cohorts 2A, 2B and 3
ORR was defined as percentage of participants with OR based assessment of CR or PR according to RECIST v1.1 that must have been confirmed ≥4 weeks later. Participants who did not have an on treatment radiographic tumor assessment due to early progression, who received anti tumor treatment other than the study medication prior to reaching a CR or PR, or who died, progressed, or dropped out for any reason prior to reaching a CR or PR were counted as non responders in the assessment of ORR. CR was defined as complete disappearance of all target lesions with the exception of nodal disease. PR was defined as Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions.
Time frame: Baseline up to end of treatment (maximum of 108 weeks)
Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Objective Response Rate (ORR) in Phase 1b/2 Cohorts 2A, 2B and 3 | 40.0 Percentage of participants |
Secondary
Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours.
Time frame: 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11 for dose-escalation cohorts, Cohorts 1 and 2B
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.467 Ratio | Geometric Coefficient of Variation 27 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.202 Ratio | Geometric Coefficient of Variation 24 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.620 Ratio | Geometric Coefficient of Variation 40 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.538 Ratio | Geometric Coefficient of Variation 25 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.035 Ratio | Geometric Coefficient of Variation 19 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.108 Ratio | Geometric Coefficient of Variation 13 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.113 Ratio | Geometric Coefficient of Variation 16 |
| Japan LIC | Observed Accumulation Ratio (Rac) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.491 Ratio | Geometric Coefficient of Variation 27 |
Secondary
Overall Survival (OS) Probability at 12 Months in Phase 1b/2 Cohorts
OS probability was based on Kaplan-Meier method. OS was defined as the time from the start date to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive.
Time frame: Baseline up to the end of study (maximum of 5 years)
Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Overall Survival (OS) Probability at 12 Months in Phase 1b/2 Cohorts | 87.5 Percentage of participants |
Secondary
PFS in PF-06747775 200 mg QD Group, Phase 1b Cohorts 2A and 3
PFS was based on Kaplan-Meier estimates. PFS was defined as the time from Cycle 1 Day 1 to the date of the first documentation of PD or death due to any cause. PD was defined as 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm.
Time frame: Cycle 1 Day 1 up to the end of study (maximum of 5 years)
Population: The response analysis population included all participants who received at least one dose of study medication, had measurable disease and adequate baseline assessment, and at least 1 post baseline assessment during the study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | PFS in PF-06747775 200 mg QD Group, Phase 1b Cohorts 2A and 3 | 8.1 Months |
Secondary
Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
Plasma area under the curve from zero to infinite time (AUCinf) of PF-06747775 as a single agent after single dose on Day -8 lead-in period in Phase 1 dose-escalation cohorts and on Day -4 lead-in period in Phase 2 Cohort 1. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 1618 ng*hr/mL | Geometric Coefficient of Variation 32 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 3195 ng*hr/mL | Geometric Coefficient of Variation 34 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 9536 ng*hr/mL | Geometric Coefficient of Variation 45 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 24100 ng*hr/mL | Geometric Coefficient of Variation 23 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 21160 ng*hr/mL | Geometric Coefficient of Variation 28 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 46170 ng*hr/mL | Geometric Coefficient of Variation 60 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 42650 ng*hr/mL | Geometric Coefficient of Variation 26 |
| Japan LIC | Plasma Area Under the Curve From Zero to Infinite Time (AUCinf) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | NA ng*hr/mL | — |
Secondary
Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
Pre-dose concentration at steady state (Ctrough) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Ctrough was defined as pre-dose concentration during multiple dosing and observed directly from data.
Time frame: Pre-dose on Cycle 1 Day 11
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 5.951 ng/mL | Geometric Coefficient of Variation 83 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 15.38 ng/mL | Geometric Coefficient of Variation 142 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 52.66 ng/mL | Geometric Coefficient of Variation 127 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 194.55 ng/mL | Geometric Coefficient of Variation 55 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 80.08 ng/mL | Geometric Coefficient of Variation 64 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 283.1 ng/mL | Geometric Coefficient of Variation 169 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 63.23 ng/mL | Geometric Coefficient of Variation 1158 |
| Japan LIC | Pre-dose Concentration at Steady State (Ctrough) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 46.84 ng/mL | Geometric Coefficient of Variation 302 |
Secondary
Rac of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
Rac of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan LIC RP2D cohort and Cycle 1 Day 15 in Japan LIC PK cohort. Rac was calculated as: Rac = (steady state AUCtau) / (single dose AUC24). AUC24 was defined as area under the plasma concentration-time curve from time 0 to 24 hours following single dose. AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohort
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Rac of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 1.322 Ratio | Geometric Coefficient of Variation 50 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Rac of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 1.766 Ratio | Geometric Coefficient of Variation 22 |
Secondary
Rss of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts
Rss of PF-06747775 following multiple doses on Cycle 1 Day 11 in Japan RP2D cohort and Cycle 1 Day 15 in Japan PK cohort. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4, Cycle 1 Day 11 for Japan LIC RP2D cohort, Cycle 1 Days 1 and 15 for Japan LIC PK cohort
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Rss of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 1.298 Ratio | Geometric Coefficient of Variation 49 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Rss of PF-06747775 Following Multiple Doses in Japan LIC RP2D and PK Cohorts | 1.689 Ratio | Geometric Coefficient of Variation 25 |
Secondary
Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B
Steady state accumulation ratio (Rss) of PF-06747775 as a single agent after multiple doses on Cycle 1 Day 11 in Phase 1 dose-escalation cohorts, Phase 2 Cohorts 1 and 2B. Rss was calculated as: Rss = (steady state AUCtau) / (single dose AUCinf). AUCtau was defined as area under the plasma concentration-time profile from time zero to tau, the dosing interval, where tau = 24 hours. AUCtau was calculated using Linear/Log trapezoidal method. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 1, 2, 4, 6, 8, 24, 48 and 72 hours post dose on Lead-in Day -8 (dose-escalation cohorts) or Day -4 (Cohort 1); 0 (pre-dose), 1, 2, 4, 6, 8 (except for Cohort 1) and 24 hours post dose on Cycle 1 Day 11
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.378 Ratio | Geometric Coefficient of Variation 28 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.130 Ratio | Geometric Coefficient of Variation 24 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.554 Ratio | Geometric Coefficient of Variation 43 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.576 Ratio | Geometric Coefficient of Variation 29 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.016 Ratio | Geometric Coefficient of Variation 19 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.108 Ratio | Geometric Coefficient of Variation 14 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | 1.086 Ratio | Geometric Coefficient of Variation 15 |
| Japan LIC | Steady State Accumulation Ratio (Rss) of PF-06747775 as a Single Agent After Multiple Doses on Cycle 1 Day 11 in Phase 1 Dose-escalation Cohorts and Phase 2 Cohorts 1 and 2B | NA Ratio | — |
Secondary
t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
t1/2 of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. t1/2 was defined as the time measured for the plasma concentration to decrease by one half.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 4.527 hrs | Standard Deviation 1.662 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 5.563 hrs | Standard Deviation 1.981 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | t1/2 of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 100 mg SD | 5.317 hrs | Standard Deviation 1.596 |
Secondary
Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1
Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf \* kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 1, 2, 4, 6, 8, 24, 48 and 72 hours post-dose on Day -8 (+/- 3 days) in lead-in period for Phase 1 dose-escalation cohorts and on Day -4 in lead-in period for Phase 2 Cohort 1
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 248.1 L | Geometric Coefficient of Variation 106 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 260.3 L | Geometric Coefficient of Variation 94 |
| Phase 1 Dose-escalation: PF-06747775 150 mg QD | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 151.0 L | Geometric Coefficient of Variation 75 |
| Phase 1 Dose-escalation: PF-06747775 275 mg QD | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 114.8 L | Geometric Coefficient of Variation 103 |
| Phase 1 Dose-escalation: PF-06747775 300 mg QD | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 83.81 L | Geometric Coefficient of Variation 44 |
| Phase 1 Dose-escalation: PF-06747775 450 mg QD | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 97.50 L | Geometric Coefficient of Variation 57 |
| Phase 1 Dose-escalation: PF-06747775 600 mg QD | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | 114.8 L | Geometric Coefficient of Variation 67 |
| Japan LIC | Volume of Distribution (Vz/F) of PF-06747775 as a Single Agent After Single Dose on Day -8 lead-in Period in Phase 1 Dose-escalation Cohorts and on Day -4 lead-in Period in Phase 2 Cohort 1 | NA L | — |
Secondary
Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort
Vz/F of PF-06747775 following a 200 mg single dose on Lead-in Day -4 in Japan LIC RP2D cohort and Cycle 1 Day 1 in Japan LIC PK cohort, and following a 100 mg single dose on Lead-in Day -7 in Japan LIC PK cohort. Vz/F was defined as apparent volume of distribution. Vz/F was calculated as: Vz/F = dose / (AUCinf \* kel). kel was defined as terminal phase rate constant and calculated by a linear regression of the log-linear concentration-time curve. AUCinf was area under the plasma concentration versus time curve (AUC) from zero to extrapolated infinite time.
Time frame: 0 (pre-dose), 1, 2, 4, 6, 8 and 24 hours post dose on Lead-in Day -4 for Japan LIC RP2D cohort, Lead-in Day -7 and Cycle 1 Day 1 for Japan LIC PK cohort
Population: The PK parameter analysis population included all treated participants who had sufficient information to estimate at least 1 of the PK parameters of interest for a particular analyte.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Phase 1 Dose-escalation: PF-06747775 25 mg QD | Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 90.94 L | Geometric Coefficient of Variation 91 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 200 mg SD | 96.23 L | Geometric Coefficient of Variation 30 |
| Phase 1 Dose-escalation: PF-06747775 50 mg QD | Vz/F of PF-06747775 Following Single Dose on Lead-in Day -4 in Japan LIC RP2D Cohort, Lead-in Day -7 and Cycle 1 Day 1 in Japan LIC PK Cohort | PF-06747775 100 mg SD | 108.2 L | Geometric Coefficient of Variation 30 |