Advanced Cancer
Conditions
Keywords
Advanced metastatic cancer (solid tumors), PI3K, mTOR, MEK
Brief summary
After the fourth protocol amendment two study arms are evaluated in this clinical protocol: PD-0325901 (oral MEK inhibitor) plus PF-05212384 (intravenous PI3K/mTOR inhibitor) and PF-05212384 plus irinotecan. The study will assess safety, pharmacokinetics and pharmacodynamics of these combinations in patients with advanced cancer. Once the maximum tolerated doses are identified, further assessment of these combinations will be done in patients with previously treated metastatic colorectal or pancreatic cancer for the PF-05212384 plus irinotecan arm and in patients with ovarian cancer or KRAS mutated non small cell lung cancer for the combination of PF-05212384 plus PD-0325901.
Detailed description
The study was prematurely discontinued as a result of an internal portfolio review on April 1, 2015. The decision to terminate was not due to any safety or efficacy data.
Interventions
DRUGPF-05212384
PF-05212384 intravenous infusion weekly starting at 110 mg.
DRUGPD-0325901
PD-0325901 Oral twice daily (BID) dosing 2 mg BID 3 weeks on 1 week off
DRUGirinotecan
Irinotecan by intravenous infusion at 180 mg/m2 every two weeks (Q x 2 week)
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological diagnosis of advanced/metastatic solid tumor for which there is no currently clinically effective treatment. * All tumor types for patients enrolled in Stage 1 of Arm C. * For patients enrolled in Stage 2 of Arm C, advanced colorectal cancer (both KRAS mutated and KRAS wild type), which has progressed on irinotecan-based regimens, and pancreatic ductal adenocarcinoma after progression on first line treatment for metastatic/advanced disease. * For patients enrolled in Stage 1 of Arm D, tumors with KRAS or BRAF mutation (archived or fresh biopsy). Patients with tumors harboring other mutations that activate the MAPK pathway may be enrolled upon agreement with the Sponsor. * For patients enrolled in Stage 2 of Arm D, ovarian cancer which has progressed on prior platinum containing regimen or KRAS mutated non small cell lung cancer which has progressed on one prior regimen. * Patients with colorectal cancer enrolled to both Arms must: 1. have received at least 6 weeks of irinotecan-based therapy (either as single agent or in combination with cytotoxic drugs or in combination with targeted therapies) as the last prior treatment 2. have progressed on or within 1 month of completing this irinotecan-based regimen * All patients must provide an archived or fresh tumor sample. * For a subset of patients fresh tumor biopsies are mandatory: a. All patients with CRC enrolled to Stage 2 of Arm C must provide a fresh tumor biopsy at baseline. A subset of patients (10 or more) with at least 5 evaluable patients with CRC KRAS wild type must also provide tumor biopsy during treatment. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) must be 0 or 1 * Adequate Bone Marrow, Renal, Cardiac, and Liver Function
Exclusion criteria
* -Patients with known active brain metastases * -Chemotherapy, radiotherapy (other than palliative radiotherapy to lesions that will not be followed for tumor assessment on this study, ie, non target lesions), biological or investigational agents within 4 weeks of the start of the study treatment (6 weeks for mitomycin C or nitrosoureas). * -Any surgery (not including minor procedures such as lymph node biopsy, needle biopsy, and/or placement of port-a-cath) within 4 weeks of start of the study treatment; or not fully recovered from any side effects of previous procedures. * -In Arm D only: Patients with glaucoma, intraocular pressure \> 21 mmHg, history of retinal vein occlusions, ocular ischemia or any other clinically significant abnormality in the ophthalmologic exam which would make the patient inappropriate for entry into this study * -For patients enrolling in Stage 2 prior therapy with an agent that is known or proposed to be active by action on PI3K and/or mTOR. * -Prior high dose chemotherapy requiring hematopoietic stem cell transplantation within 12 months of study treatment start. * -Known impaired pulmonary function or demonstrated to be impaired by Pulmonary Function Test (PFT) for patients who present with clinical suggestion of impairment. * -Uncontrolled or significant cardiovascular disease * -Current use or anticipated need for food or drugs that are known potent CYP3A4 inhibitors * \- Current or anticipated need for food or drugs that are known potent CYP3A4 inducers
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | Baseline up to 28 days | DLT was defined as any of the following hematologic or non-hematologic events which were attributable to the combination study drug and occurring in the first 28-day cycle: 1) Grade 4 neutropenia lasting greater than (\>)7 days; 2) Febrile neutropenia (defined as neutropenia greater than or equal to \[≥\]Grade 3 and a body temperature ≥38.5°C); 3) Grade ≥3 neutropenic infection; 4) Grade 3 thrombocytopenia with bleeding; 5) Grade 4 thrombocytopenia; 6) Grade ≥3 toxicities; 7) Persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses during the first cycle; 8) Persistent, intolerable toxicities which resulted in delay of start of Cycle 2 by more than 2 weeks of scheduled day; 9) Persistent Grade 3 QTc prolongation (QTc \>500 msec) after correction of any reversible causes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded by the NCI CTCAE (Version 4.0). |
| Number of Participants With Laboratory Test Abnormalities (Hematology) | Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration) | Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities. Hematological tests included platelet count, hemoglobin, and white blood cell (WBC) count with 5- part differential. |
| Number of Participants With Laboratory Test Abnormalities (Coagulation) | Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration) | Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 coagulation test abnormalities. Coagulation tests included partial thromboplastin time (PTT) and prothrombin time (PT) international normalized ratio (INR). |
| Number of Participants With Laboratory Test Abnormalities (Chemistry) | Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration) | Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry test abnormalities. Chemistry tests included aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]), serum creatinine, total bilirubin, direct/indirect bilirubin, alkaline phosphatase, chloride, uric acid, phosphorus, calcium, magnesium, potassium, sodium, blood urea nitrogen (BUN) or urea, total protein, albumin, glucose, and insulin. |
| Number of Participants With Laboratory Test Abnormalities (Urinalysis) | Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration) | Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 urinalysis test abnormalities for urine protein. |
| Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration) | Number of participants with vital signs values meeting prespecified criteria. Criteria defined as: 1) absolute systolic blood pressue (SBP) less than or equal to (\<=) 100 millimeter of mercury (mmHg); 2) absolute SBP greater than or equal to (\>=) 160 mmHg, 3) SBP maximum increase of \>=20 mmHg from baseline; 4) SBP maximum increase of \>=40 mmHg from baseline; 5) SBP maximum increase of \>=60 mmHg from baseline; 6) absolute diastolic blood pressure (DBP) \<=60 mmHg; 7) absolute DBP \>=100 mmHg; 8) DBP maximum increase of \>=10 mmHg from baseline; 9) DBP maximum increase of \>=20 mmHg from baseline; 10) DBP maximum increase of \>=30 mmHg from baseline; 11) absolute heart rate (HR) \<50 beats per minute (bpm); 12) absolute HR \>120 bpm. |
| Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose. | — |
| Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose. | — |
| Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose. | — |
| Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose. | — |
| Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose. | — |
| Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose. | — |
| Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A | Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. | — |
| Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A | Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose. | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A | Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B | Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours. | — |
| Number of Participants With Increase From Baseline in QT Interval | Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration) | Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF) . |
| Number of Participants With Maximum Post-dose QT Interval Corrected | Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration) | Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF). |
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) | Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented. | CR was defined as the disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. |
| Progression-Free Survival (PFS) (Stage 2) | Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented. | Progression-free survival (PFS) was the time from first dose to date of first documentation of progression or death due to any cause. |
| Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration) | — |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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. |
| Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A | Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration) | — |
| Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A | Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration) | — |
| Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | Baseline and Cycle 1 Day 23. | Number of participants with expression of genes relating to PI3K, MAPK and/or Wnt pathway signaling (kirsten rat sarcoma 2 viral oncogene homolog \[KRAS\] and PTEN protein). Biopsies were obtained at baseline and Cycle 1 Day 23. Biomarker evaluation was performed on these biopsies. |
| Duration of Response (Stage 2) | Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until until progression of disease was documented. | Duration of response was to be calculated for participants with an objective response. Duration of PR or CR was the time from start date (date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions. |
| Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration) | — |
Countries
Canada, Italy, Spain, United States
Participant flow
Pre-assignment details
In Arms A and B, 7 and 14 participants were screed and received study treatment, respectively. In Arm C, 45 participants were screened and 44 received study treatment. In Arm D, 39 participants were screened and 37 received study treatment. There was no Stage 2 for Arm D, the study was terminated before enrolling patients to Stage 2 for Arm D.
Participants by arm
| Arm | Count |
|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) Single oral dose of PF-04691502 4 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 5 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) Single oral dose of PF-04691502 6 mg tablet and PF 0325901 8 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily and PF 0325901 8 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 1 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) Single oral dose of PF-04691502 4 mg tablet and PF 0325901 5 mg capsule in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily and PF 0325901 5 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 1 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. | 7 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) Single oral dose of PF-04691502 6 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 6 mg tablet orally once daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. | 7 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) Participants received intravenous doses of PF-05212384 95 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. | 3 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. | 6 |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) Participants received intravenous doses of PF-05212384 130 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. | 4 |
| PF-05212384+Irinotecan: Arm C2 (Stage 2) Participants received intravenous doses of PF-05212384 110 mg weekly on Days 2, 9, 16 and 23 of each 28 day cycle. Irinotecan 180 mg/m\^2 dosed intravenously biweekly. During Stage 2, only participants with metastatic colorectal cancer (mCRC) and pancreatic ductal adenocarcinoma (PDAC) were enrolled. | 31 |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 7 |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 3 |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 2 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 2 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 4 |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 7 |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 7 |
| PF-05212384+ PD-0325901: Arm D1B (Stage 1)) Single intravenous dose of PF-05212384 154 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 154 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 4 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF 0325901 4 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 3 |
| PF-05212384+ PD-0325901: Arm D2 (Stage 1) Single intravenous dose of PF-05212384 110 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 110 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 4 |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) Single intravenous dose of PF-05212384 130 mg in lead-in period (Day 14 prior to Cycle 1 day 1) followed by intravenous doses of PF-05212384 130 mg on Days 1, 8, 15 and 22. Single oral dose of PF 0325901 6 mg capsule in lead-in period (Day 7 to Day 1 prior to Cycle 1 Day 1), followed by PF-0325901 6 mg capsule orally twice daily continuously on Days 2-12 and 16-26 of each cycle until participants experienced unacceptable toxicity, disease progression, withdrawal from the study, or death. | 2 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 1 | 2 | 2 | 1 | 0 | 4 | 1 | 3 | 1 | 2 | 0 | 0 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Other | 3 | 1 | 1 | 4 | 5 | 0 | 5 | 3 | 22 | 5 | 0 | 3 | 4 | 4 | 2 | 3 | 0 |
| Overall Study | Subject refused further follow-up | 2 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 4 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | PF-05212384+ PD-0325901: Arm D0B (Stage 1) | PF-05212384+Irinotecan: Arm C2 (Stage 1) | PF-04691502+PF 0325901: Arm A2 (Stage1) | PF-05212384+Irinotecan: Arm C3 (Stage 1) | PF-04691502+PF 0325901: Arm A4 (Stage1) | PF-05212384+ PD-0325901: Arm D0A (Stage 1) | PF-05212384+ PD-0325901: Arm D2A (Stage 1) | PF-05212384+ PD-0325901: Arm D0 (Stage 1) | PF-05212384+Irinotecan: Arm C2 (Stage 2) | PF-05212384+ PD-0325901: Arm D2 (Stage 1) | PF-04691502+Irinotecan: Arm B1 (Stage 1) | PF-04691502+PF-0325901: Arm A1 (Stage1) | PF-05212384+ PD-0325901: Arm D1B (Stage 1)) | PF-04691502+Irinotecan: Arm B2 (Stage 1) | PF-05212384+ PD-0325901: Arm D1A (Stage 1) | PF-05212384+ PD-0325901: Arm D1 (Stage 1) | PF-05212384+Irinotecan: Arm C1 (Stage 1) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 64.0 years STANDARD_DEVIATION 8.9 | 60.8 years STANDARD_DEVIATION 7.2 | 54.0 years STANDARD_DEVIATION 0 | 63.3 years STANDARD_DEVIATION 14.5 | 49.0 years STANDARD_DEVIATION 0 | 43.3 years STANDARD_DEVIATION 9.1 | 54.5 years STANDARD_DEVIATION 9.2 | 63.3 years STANDARD_DEVIATION 5.9 | 56.7 years STANDARD_DEVIATION 12.4 | 60.0 years STANDARD_DEVIATION 11.8 | 53.6 years STANDARD_DEVIATION 14.1 | 58.8 years STANDARD_DEVIATION 8.7 | 61.3 years STANDARD_DEVIATION 14.2 | 59.1 years STANDARD_DEVIATION 12.9 | 57.9 years STANDARD_DEVIATION 12.9 | 55.7 years STANDARD_DEVIATION 10 | 67.0 years STANDARD_DEVIATION 3.6 | 58.5 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 3 Participants | 13 Participants | 2 Participants | 5 Participants | 3 Participants | 0 Participants | 2 Participants | 2 Participants | 3 Participants | 2 Participants | 44 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 1 Participants | 2 Participants | 1 Participants | 2 Participants | 0 Participants | 4 Participants | 18 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 5 Participants | 5 Participants | 4 Participants | 1 Participants | 58 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 | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 5 | 1 / 1 | 1 / 1 | 7 / 7 | 7 / 7 | 3 / 3 | 6 / 6 | 4 / 4 | 31 / 31 | 7 / 7 | 3 / 3 | 4 / 4 | 7 / 7 | 7 / 7 | 3 / 3 | 4 / 4 | 2 / 2 |
| serious Total, serious adverse events | 2 / 5 | 1 / 1 | 1 / 1 | 2 / 7 | 5 / 7 | 0 / 3 | 0 / 6 | 2 / 4 | 5 / 31 | 3 / 7 | 1 / 3 | 2 / 4 | 4 / 7 | 1 / 7 | 0 / 3 | 1 / 4 | 0 / 2 |
Outcome results
Primary
Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days)
DLT was defined as any of the following hematologic or non-hematologic events which were attributable to the combination study drug and occurring in the first 28-day cycle: 1) Grade 4 neutropenia lasting greater than (\>)7 days; 2) Febrile neutropenia (defined as neutropenia greater than or equal to \[≥\]Grade 3 and a body temperature ≥38.5°C); 3) Grade ≥3 neutropenic infection; 4) Grade 3 thrombocytopenia with bleeding; 5) Grade 4 thrombocytopenia; 6) Grade ≥3 toxicities; 7) Persistent, intolerable toxicities which resulted in failure to deliver at least 75% of doses during the first cycle; 8) Persistent, intolerable toxicities which resulted in delay of start of Cycle 2 by more than 2 weeks of scheduled day; 9) Persistent Grade 3 QTc prolongation (QTc \>500 msec) after correction of any reversible causes.
Time frame: Baseline up to 28 days
Population: All enrolled participants who started treatment and who did not have a major pre-specified treatment deviation in the first cycle of treatment in Stage 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 40.0 percentage of participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 100 percentage of participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 14.3 percentage of participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 40.0 percentage of participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 50.0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 14.3 percentage of participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 14.3 percentage of participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 14.3 percentage of participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Percentage of Participants With Dose-Limiting Toxicities (DLTs) in First Cycle (28 Days) | 0 percentage of participants |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A
Time frame: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A | 1599 ng*hr/mL | Geometric Coefficient of Variation 26 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A | 2140 ng*hr/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PD-0325901 on Cycle 0 Day -7 for Arm A | 1060 ng*hr/mL | — |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A | 523.9 ng*hr/mL | Geometric Coefficient of Variation 21 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A | 950 ng*hr/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm A | 697 ng*hr/mL | — |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B | 705.0 ng*hr/mL | Geometric Coefficient of Variation 41 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-04691502 on Cycle 0 Day -7 for Arm B | 1028 ng*hr/mL | Geometric Coefficient of Variation 36 |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Time frame: Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 6353 ng*hr/mL | Geometric Coefficient of Variation 40 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 10430 ng*hr/mL | Geometric Coefficient of Variation 33 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 10460 ng*hr/mL | Geometric Coefficient of Variation 20 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 12460 ng*hr/mL | Geometric Coefficient of Variation 2 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 14880 ng*hr/mL | Geometric Coefficient of Variation 39 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 20440 ng*hr/mL | Geometric Coefficient of Variation 26 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 12600 ng*hr/mL | Geometric Coefficient of Variation 29 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 13770 ng*hr/mL | Geometric Coefficient of Variation 20 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 14620 ng*hr/mL | Geometric Coefficient of Variation 23 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 23730 ng*hr/mL | Geometric Coefficient of Variation 39 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 14230 ng*hr/mL | Geometric Coefficient of Variation 46 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 15500 ng*hr/mL | — |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 13320 ng*hr/mL | Geometric Coefficient of Variation 27 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 9766 ng*hr/mL | Geometric Coefficient of Variation 22 |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | NA ng*hr/mL | — |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 21300 ng*hr/mL | — |
Secondary
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C
Time frame: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 7540 ng*hr/mL | — |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 5870 ng*hr/mL | — |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 8627 ng*hr/mL | Geometric Coefficient of Variation 26 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 7968 ng*hr/mL | Geometric Coefficient of Variation 41 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 9277 ng*hr/mL | Geometric Coefficient of Variation 48 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 9174 ng*hr/mL | Geometric Coefficient of Variation 17 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 10070 ng*hr/mL | Geometric Coefficient of Variation 42 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 10610 ng*hr/mL | Geometric Coefficient of Variation 37 |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A
Time frame: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A | 1479 ng*hr/mL | Geometric Coefficient of Variation 23 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A | 2030 ng*hr/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PD-0325901 on Cycle 0 Day -7 for Arm A | 941 ng*hr/mL | — |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A | 474.5 ng*hr/mL | Geometric Coefficient of Variation 29 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A | 933 ng*hr/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm A | 688 ng*hr/mL | — |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B | 588.4 ng*hr/mL | Geometric Coefficient of Variation 49 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-04691502 on Cycle 0 Day -7 for Arm B | 1001 ng*hr/mL | Geometric Coefficient of Variation 35 |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Time frame: Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 7627 ng*hr/mL | Geometric Coefficient of Variation 46 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 12070 ng*hr/mL | Geometric Coefficient of Variation 36 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 10250 ng*hr/mL | Geometric Coefficient of Variation 21 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 12130 ng*hr/mL | Geometric Coefficient of Variation 1 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 14850 ng*hr/mL | Geometric Coefficient of Variation 31 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 19970 ng*hr/mL | Geometric Coefficient of Variation 25 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 12590 ng*hr/mL | Geometric Coefficient of Variation 27 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 13390 ng*hr/mL | Geometric Coefficient of Variation 21 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 14280 ng*hr/mL | Geometric Coefficient of Variation 24 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 21170 ng*hr/mL | Geometric Coefficient of Variation 36 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 13840 ng*hr/mL | Geometric Coefficient of Variation 47 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 15200 ng*hr/mL | — |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 12610 ng*hr/mL | Geometric Coefficient of Variation 25 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 9619 ng*hr/mL | Geometric Coefficient of Variation 22 |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | NA ng*hr/mL | — |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 20800 ng*hr/mL | — |
Secondary
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C
Time frame: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | NA ng*hr/mL | — |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 8819 ng*hr/mL | Geometric Coefficient of Variation 71 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 8243 ng*hr/mL | Geometric Coefficient of Variation 25 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 7487 ng*hr/mL | Geometric Coefficient of Variation 41 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 10530 ng*hr/mL | Geometric Coefficient of Variation 44 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 11170 ng*hr/mL | Geometric Coefficient of Variation 53 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 9485 ng*hr/mL | Geometric Coefficient of Variation 43 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for PF-05212384 on Cycle 1 Day 2 and Cycle 1 Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 10890 ng*hr/mL | Geometric Coefficient of Variation 38 |
Secondary
Duration of Response (Stage 2)
Duration of response was to be calculated for participants with an objective response. Duration of PR or CR was the time from start date (date of first documentation of PR or CR) to date of first documentation of objective progression or death. CR: disappearance of a target lesions. PR: at least 30% decrease in the sum of diameters of target lesions.
Time frame: Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until until progression of disease was documented.
Population: There was only 1 participant in Arm C1 and 1 in Arm C2 with a response, therefore summary statistics were not calculated for this endpoint.
Secondary
Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D
Time frame: Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 85.28 ng/mL | Geometric Coefficient of Variation 27 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 91.69 ng/mL | Geometric Coefficient of Variation 31 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 63.80 ng/mL | Geometric Coefficient of Variation 14 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 74.23 ng/mL | Geometric Coefficient of Variation 43 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 87.99 ng/mL | Geometric Coefficient of Variation 51 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 64.99 ng/mL | Geometric Coefficient of Variation 56 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 180.6 ng/mL | Geometric Coefficient of Variation 28 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 138.7 ng/mL | Geometric Coefficient of Variation 23 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 191.9 ng/mL | Geometric Coefficient of Variation 44 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 183.6 ng/mL | Geometric Coefficient of Variation 29 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 115.8 ng/mL | Geometric Coefficient of Variation 70 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 114.6 ng/mL | Geometric Coefficient of Variation 50 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 211.9 ng/mL | Geometric Coefficient of Variation 44 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 231.3 ng/mL | Geometric Coefficient of Variation 69 |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | NA ng/mL | — |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | NA ng/mL | — |
Secondary
Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Time frame: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 304.9 ng/mL | Geometric Coefficient of Variation 49 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 341.9 ng/mL | Geometric Coefficient of Variation 21 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 280 ng/mL | — |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 690 ng/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 101 ng/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 182 ng/mL | — |
Secondary
Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 38.02 ng/mL | Geometric Coefficient of Variation 28 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 52.02 ng/mL | Geometric Coefficient of Variation 13 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 59.8 ng/mL | — |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 21.2 ng/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 48.7 ng/mL | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 64.7 ng/mL | — |
Secondary
Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 (N=7, 7) | 41.44 ng/mL | Standard Deviation 8.1201 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 1 Day 12 (N=7, 5) | 46.81 ng/mL | Standard Deviation 19.381 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 (N=7, 7) | 68.41 ng/mL | Standard Deviation 31.818 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 1 Day 12 (N=7, 5) | 87.30 ng/mL | Standard Deviation 37.647 |
Secondary
Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Time frame: Cycle 0 Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 3625 ng/mL | Geometric Coefficient of Variation 62 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 8621 ng/mL | Geometric Coefficient of Variation 18 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 5937 ng/mL | Geometric Coefficient of Variation 32 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 6153 ng/mL | Geometric Coefficient of Variation 34 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 11170 ng/mL | Geometric Coefficient of Variation 16 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 12440 ng/mL | Geometric Coefficient of Variation 32 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 8476 ng/mL | Geometric Coefficient of Variation 32 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 8717 ng/mL | Geometric Coefficient of Variation 50 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 8586 ng/mL | Geometric Coefficient of Variation 36 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 8913 ng/mL | Geometric Coefficient of Variation 54 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 6279 ng/mL | Geometric Coefficient of Variation 70 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 9280 ng/mL | — |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 7989 ng/mL | Geometric Coefficient of Variation 45 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 7239 ng/mL | Geometric Coefficient of Variation 39 |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | NA ng/mL | — |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 15400 ng/mL | — |
Secondary
Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Time frame: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | NA nanogram (ng)/milliliter (mL) | — |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 2201 nanogram (ng)/milliliter (mL) | Geometric Coefficient of Variation 16 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 2814 nanogram (ng)/milliliter (mL) | Geometric Coefficient of Variation 50 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 3404 nanogram (ng)/milliliter (mL) | Geometric Coefficient of Variation 82 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 4759 nanogram (ng)/milliliter (mL) | Geometric Coefficient of Variation 25 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 4656 nanogram (ng)/milliliter (mL) | Geometric Coefficient of Variation 32 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 5221 nanogram (ng)/milliliter (mL) | Geometric Coefficient of Variation 61 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Maximum Plasma Concentrations (Cmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 5728 nanogram (ng)/milliliter (mL) | Geometric Coefficient of Variation 56 |
Secondary
Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling
Number of participants with expression of genes relating to PI3K, MAPK and/or Wnt pathway signaling (kirsten rat sarcoma 2 viral oncogene homolog \[KRAS\] and PTEN protein). Biopsies were obtained at baseline and Cycle 1 Day 23. Biomarker evaluation was performed on these biopsies.
Time frame: Baseline and Cycle 1 Day 23.
Population: All enrolled participants who started treatment and had baseline tumor tissues successfully analyzed for at least one of the biomarkers.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 4 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 4 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 4 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 1 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 5 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 5 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 6 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 6 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 3 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 3 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 3 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 5 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 2 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 4 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 4 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 1 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 4 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 24 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 10 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 24 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 2 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 4 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 4 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 2 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 1 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 2 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 2 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 3 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 3 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 6 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 6 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 4 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 7 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 7 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 6 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 2 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 2 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN stroma manual score | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | KRAS mutation | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Expression of Genes Relating to Phosphatidylinositol 3 Kinase (PI3K), Mitogen Activated Protein Kinase (MAPK) and/or Wingless-Type Mouse Mammary Tumor Virus Integration Site Family Member (Wnt) Pathway Signaling | PTEN tumor manual score | 1 participants |
Secondary
Number of Participants With Increase From Baseline in QT Interval
Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF) .
Time frame: Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)
Population: All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 5 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 4 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 7 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 7 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 5 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 2 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 7 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 2 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 2 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 1 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 5 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 1 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 5 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 3 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 1 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 4 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 28 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 24 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 6 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 6 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 7 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 3 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 6 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 6 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 5 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 4 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 3 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 3 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 4 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 3 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase >=60 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase <30msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcB Interval Increase >=30to<60msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | MaximumQTcF Interval Increase >=30 to<60msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcF Interval Increase <30 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Increase From Baseline in QT Interval | Maximum QTcB Interval Increase >=60 msec | 0 participants |
Secondary
Number of Participants With Laboratory Test Abnormalities (Chemistry)
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry test abnormalities. Chemistry tests included aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\]), alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \[SGPT\]), serum creatinine, total bilirubin, direct/indirect bilirubin, alkaline phosphatase, chloride, uric acid, phosphorus, calcium, magnesium, potassium, sodium, blood urea nitrogen (BUN) or urea, total protein, albumin, glucose, and insulin.
Time frame: Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)
Population: All enrolled participants who started treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 1 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 3 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 4 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 3 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 1 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 4 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 2 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 0 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 2 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 5 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 3 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 5 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 3 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 1 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 1 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 2 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 5 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 4 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 3 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 2 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 3 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 2 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 2 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 5 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 4 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 6 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 3 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 2 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 5 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 5 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 3 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 6 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 1 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 1 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 6 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 4 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 3 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 2 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 6 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 3 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 4 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 6 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 1 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 3 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 3 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 1 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 1 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 2 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 1 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 3 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 5 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 1 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 2 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 2 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 3 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 3 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 5 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 3 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 1 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 2 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 2 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 4 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 3 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 13 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 22 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 16 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 3 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 21 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 25 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 18 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 13 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 14 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 10 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 14 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 8 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 5 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 5 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 2 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 4 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 3 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 4 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 0 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 3 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 2 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 2 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 2 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 2 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 4 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 3 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 3 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 2 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 2 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 4 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 5 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 1 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 5 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 5 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 6 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 6 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 4 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 7 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 4 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 1 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 7 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 6 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 2 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 4 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 2 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 2 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 4 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 3 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 4 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 6 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 2 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 6 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 3 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 2 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 3 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 1 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 3 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 3 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 1 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 1 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 1 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 1 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 3 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 3 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 4 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 4 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 4 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypermagnesemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypernatremia | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperglycemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoalbuminemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypercalcemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypocalcemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | creatinine | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypoglycemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Total bilirubin | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | AST | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypokalemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypomagnesemia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | Alkaline phosphatase | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyponatremia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | ALT | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hypophosphatemia | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Chemistry) | hyperkalemia | 0 participant |
Secondary
Number of Participants With Laboratory Test Abnormalities (Coagulation)
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 coagulation test abnormalities. Coagulation tests included partial thromboplastin time (PTT) and prothrombin time (PT) international normalized ratio (INR).
Time frame: Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)
Population: All enrolled participants who started treatment. N=number of evaluable participants for each parameter.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 1 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 2 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 5 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 5 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 1 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 21 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 13 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 0 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 1 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 1 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 3 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 5 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PTT (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Coagulation) | PT INR (N=5,1,1,7,7,3,6,4,30,7,3,4,7,7,3,4,2) | 0 participant |
Secondary
Number of Participants With Laboratory Test Abnormalities (Hematology)
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities. Hematological tests included platelet count, hemoglobin, and white blood cell (WBC) count with 5- part differential.
Time frame: Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)
Population: All enrolled participants who started treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 3 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 5 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 1 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 3 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 5 participant |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 1 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 0 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 0 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 5 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 4 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 7 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 5 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 3 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 7 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 6 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 3 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 2 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 3 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 3 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 3 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 1 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 3 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 1 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 5 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 2 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 3 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 6 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 4 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 4 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 22 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 31 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 1 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 18 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 10 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 22 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 6 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 1 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 0 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 1 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 5 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 0 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 0 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 1 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 1 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 2 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 6 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 1 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 7 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 2 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 1 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 3 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 6 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 1 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 0 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 1 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 5 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 1 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 3 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 3 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 3 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphopenia | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Lymphocyte Count Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | White Blood Cells | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Hemoglobin Increased | 0 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Absolute Neutrophils | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Anemia | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Hematology) | Platelets | 1 participant |
Secondary
Number of Participants With Laboratory Test Abnormalities (Urinalysis)
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 urinalysis test abnormalities for urine protein.
Time frame: Baseline, Days 1 and 15 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)
Population: All enrolled participants who started treatment. Number of participants analyzed=number of evaluable participants for each laboratory parameter.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 2 participant |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 1 participant |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 1 participant |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 6 participant |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 4 participant |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 1 participant |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 3 participant |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 1 participant |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 15 participant |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 3 participant |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 0 participant |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 2 participant |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 5 participant |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 4 participant |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 1 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 2 participant |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Laboratory Test Abnormalities (Urinalysis) | 0 participant |
Secondary
Number of Participants With Maximum Post-dose QT Interval Corrected
Electrocardiogram (ECG) measurements (an average of the triplicate measurements) were used for the statistical analysis and all data presentations. QT intervals were corrected for heart rate (QTc) using Bazett's Formula (QTcB) and Fridericia's Formula (QTcF).
Time frame: Baseline, Cycle 1 Day 2 for Arms C and D, Cycle 1 Day 15 for Arm D, and Cycle 1 Day 16 for Arm C, Day 2 in Arm C and Day 1 in Arm D for subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)
Population: All participants enrolled in the study having at least one ECG assessment after receiving study drug for the respective arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 3 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 2 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 4 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 1 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 1 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 3 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 4 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 7 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 3 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 3 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 4 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 4 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 1 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 2 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 3 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 6 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 4 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 2 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 1 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 3 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 2 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 2 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 22 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 5 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 24 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 5 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 5 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 6 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 3 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 3 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 4 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 3 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 6 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 5 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 2 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 2 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 2 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 1 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 4 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 5 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 3 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 3 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval <450 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval >480 to <=500 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval <450 msec | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >500 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcF Interval 450 to <=480 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval 450 to <=480 msec | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Maximum Post-dose QT Interval Corrected | Maximum QTcB Interval >480 to <=500 msec | 1 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. 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.
Time frame: Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)
Population: All enrolled participants who started treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 5 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 1 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 31 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 5 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 3 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 2 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 4 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 7 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 3 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 4 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 participants |
Secondary
Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded by the NCI CTCAE (Version 4.0).
Time frame: Baseline up to End of Treatment (EOT) (within 28 days after last treatment administration)
Population: All enrolled participants who started treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 1 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 5 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 2 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 7 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 5 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 2 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 7 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 5 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 3 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 3 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 4 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 6 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 2 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 4 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 2 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 1 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 4 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 7 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 10 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 10 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 31 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 7 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 3 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 3 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 4 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 2 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 2 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 3 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 7 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 4 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 1 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 7 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 3 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 2 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 3 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 4 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Missing or Unknown | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Treatment-Emergent AEs (TEAEs) by National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
Secondary
Number of Participants With Vital Signs Values Meeting Prespecified Criteria
Number of participants with vital signs values meeting prespecified criteria. Criteria defined as: 1) absolute systolic blood pressue (SBP) less than or equal to (\<=) 100 millimeter of mercury (mmHg); 2) absolute SBP greater than or equal to (\>=) 160 mmHg, 3) SBP maximum increase of \>=20 mmHg from baseline; 4) SBP maximum increase of \>=40 mmHg from baseline; 5) SBP maximum increase of \>=60 mmHg from baseline; 6) absolute diastolic blood pressure (DBP) \<=60 mmHg; 7) absolute DBP \>=100 mmHg; 8) DBP maximum increase of \>=10 mmHg from baseline; 9) DBP maximum increase of \>=20 mmHg from baseline; 10) DBP maximum increase of \>=30 mmHg from baseline; 11) absolute heart rate (HR) \<50 beats per minute (bpm); 12) absolute HR \>120 bpm.
Time frame: Baseline, Days 1, 15, and 23 of Cycle 1, Days 1 and 15 of Cycle 2, Day 1 of Cycle 3 and subsequent cycles, up to End of Treatment (within 28 days of last treatment administration)
Population: All enrolled participants who started treatment. N=number of participants evaluated against criteria.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 3 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 4 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 4 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 3 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 14 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 9 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 10 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 4 participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 7 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 2 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 3 participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 2 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 3 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 3 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 3 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 3 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 8 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 2 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion10 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion11 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 7 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 3 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 4 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion12 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 6 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 1 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 1 (N=5,1,1,7,7,3,6,4,31,7,3,4,7,7,3,4,2) | 2 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 5 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Number of Participants With Vital Signs Values Meeting Prespecified Criteria | Criterion 9 (N=5,1,1,6,7,3,6,4,31,7,3,3,7,4,3,4,1) | 0 participants |
Secondary
Percentage of Participants With Complete Response (CR) or Partial Response (PR)
CR was defined as the disappearance of all target lesions with the exception of nodal disease and all target nodes must decrease to normal size (short axis \<10 mm). PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions.
Time frame: Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.
Population: All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 33.3 percentage of participants |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 3.3 percentage of participants |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 33.3 percentage of participants |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 28.6 percentage of participants |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 14.3 percentage of participants |
| PF-05212384+PD-0325901: Arm D2 (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
| PF-05212384+ PD-0325901: Arm D2A (Stage 1) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) | 0 percentage of participants |
Secondary
Progression-Free Survival (PFS) (Stage 2)
Progression-free survival (PFS) was the time from first dose to date of first documentation of progression or death due to any cause.
Time frame: Baseline, every 8 weeks in Cycle 3 and subsequent cycles, until progression of disease was documented.
Population: All participants who started treatment on the assigned arm and had an adequate baseline tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Progression-Free Survival (PFS) (Stage 2) | 2.8 months |
Secondary
Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A
Time frame: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)
Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A | 0.965 ratio | Standard Deviation 0.2697 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Ratio to Baseline in Serum Glucose Level at Cycle 2 Day 16 for Arm A | NA ratio | — |
Secondary
Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D
Time frame: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)
Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | 0.974 ratio | Standard Deviation 0.0864 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | 1.015 ratio | Standard Deviation 0.1935 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | 1.011 ratio | Standard Deviation 0.1165 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | 1.111 ratio | Standard Deviation 0.2895 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | 1.212 ratio | Standard Deviation 0.3284 |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | 0.966 ratio | Standard Deviation 0.1904 |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | 1.13 ratio | Standard Deviation 0.3886 |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Ratio to Baseline in Serum Glucose Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
Secondary
Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A
Time frame: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)
Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A | 0.652 ratio | Standard Deviation 0.3622 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Ratio to Baseline in Serum Insulin Level at Cycle 2 Day 16 for Arm A | NA ratio | — |
Secondary
Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D
Time frame: Baseline, Cycle 1 Days 2, 15, 22, and 23, Cycle 2 Days 1 and 16, Day 1 in Cycle 3 and subsequent cycles, and EOT (within 28 days after last treatment administration)
Population: All enrolled participants who started treatment and had baseline and on treatment serum biomarker samples (glucose, insulin, or other serum biomarkers) successfully analyzed for at least one of the biomarkers.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | 1.628 ratio | Standard Deviation 1.888 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | 2.178 ratio | Standard Deviation 2.3194 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | 1.699 ratio | Standard Deviation 2.0031 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+ PD-0325901: Arm D0 (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+ PD-0325901: Arm D0A (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | 2.233 ratio | Standard Deviation 2.3617 |
| PF-05212384+ PD-0325901: Arm D0B (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+ PD-0325901: Arm D1 (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+ PD-0325901: Arm D1A (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
| PF-05212384+PD-0325901: Arm D1B (Stage 1) | Ratio to Baseline in Serum Insulin Level at End of Treatment for Arm B, Arm C, and Arm D | NA ratio | — |
Secondary
Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A
Time frame: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the pharmacokinetic (PK) parameters of interest estimated.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A | 13.92 hr | Standard Deviation 4.226 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A | 18.3 hr | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Terminal Elimination Half Life (t½) for PD-0325901 on Cycle 0 Day -7 for Arm A | 25.7 hr | — |
Secondary
Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Time frame: Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 24.62 hr | Standard Deviation 3.2306 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 35.90 hr | Standard Deviation 4.8816 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 27.37 hr | Standard Deviation 6.4748 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 39.30 hr | Standard Deviation 10.678 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 30.77 hr | Standard Deviation 6.4933 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 41.25 hr | Standard Deviation 6.2303 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 25.85 hr | Standard Deviation 4.153 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 34.43 hr | Standard Deviation 8.5383 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 29.35 hr | Standard Deviation 5.5121 |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 40.20 hr | Standard Deviation 5.8643 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 29.63 hr | Standard Deviation 3.7072 |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 37.0 hr | — |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 33.30 hr | Standard Deviation 0.96437 |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | 27.05 hr | Standard Deviation 4.6651 |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=5, 3, 3, 6, 6, 3, 4, 2) | NA hr | — |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=3, 3, 4, 6, 3, 1, 3, 1) | 37.0 hr | — |
Secondary
Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Time frame: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 24.5 hr | — |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 33.3 hr | — |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 37.98 hr | Standard Deviation 5.5603 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 32.14 hr | Standard Deviation 1.3334 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 29.23 hr | Standard Deviation 7.1066 |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 34.50 hr | Standard Deviation 8.4256 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=1, 5, 3, 25) | 32.16 hr | Standard Deviation 4.5154 |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Terminal Elimination Half Life (t½) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=1, 5, 3, 20) | 35.10 hr | Standard Deviation 3.3067 |
Secondary
Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 9.374 hr | Standard Deviation 1.3243 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 0, 0) | 8.968 hr | Standard Deviation 1.5366 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 12.4 hr | — |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 0, 0) | NA hr | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 11.5 hr | — |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 0, 0) | NA hr | — |
Secondary
Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 (N=6, 7) | 13.13 hr | Standard Deviation 2.2879 |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 1 Day 12 (N=3, 1) | 8.597 hr | Standard Deviation 1.2726 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 (N=6, 7) | 13.06 hr | Standard Deviation 2.6589 |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Terminal Elimination Half Life (t1/2) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 1 Day 12 (N=3, 1) | 8.97 hr | — |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D
Time frame: Cycle 0 Day -1 and Cycle 1 Day 1: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 1.00 hr |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 1.00 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 2.00 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 2.00 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 1.03 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 1.00 hr |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 1.97 hr |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 2.00 hr |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 1.07 hr |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 1.00 hr |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 1.00 hr |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 2.00 hr |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 1.50 hr |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 2.00 hr |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 0 Day -1 (N=7, 3, 3, 7, 7, 3, 3, 2) | 2.50 hr |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -1 and Cycle 1 Day 1 for Arm D | Cycle 1 Day 1 (N=5, 3, 3, 6, 6, 3, 4, 2) | 1.00 hr |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Time frame: Cycle 0 Day -7: Pre-dose and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12: Pre-dose and 1, 2, 4, 6 and 8 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 1.00 hr |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 1.00 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 2.00 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 1.00 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 1.92 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PD-0325901 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 4.00 hr |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose), 1, 2, 4, 6, 8, 24, and 72 hours, and at Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6, 8, and 24 hours.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 1.00 hr |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 2.00 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 1.00 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 0.00 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 0 Day -7 (N=5, 1, 1) | 1.90 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm A | Cycle 1 Day 12 (N=4, 1, 1) | 2.00 hr |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B
Time frame: Cycle 0 Day -7 at 0 hours (pre-dose) and 1, 2, 4, 6, 8, 24, and 72 hours post-dose. Cycle 1 Day 12 at 0 hours (pre-dose), 1, 2, 4, 6 8 and 24 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 (N=7, 7) | 2 hr |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 1 Day 12 (N=7, 5) | 2 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 0 Day -7 (N=7, 7) | 1.07 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-04691502 on Cycle 0 Day -7 and Cycle 1 Day 12 for Arm B | Cycle 1 Day 12 (N=7, 5) | 2.03 hr |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D
Time frame: Day -14 and Cycle 1 Day 15: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 0.500 hr |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.500 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 0.500 hr |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.500 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 0.500 hr |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.500 hr |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 0.500 hr |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.509 hr |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 0.509 hr |
| PF-04691502+Irinotecan: Arm B2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.517 hr |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 1.00 hr |
| PF-05212384+Irinotecan: Arm C1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.667 hr |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.500 hr |
| PF-05212384+Irinotecan: Arm C2 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 0.500 hr |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 0 Day -14 (N=7, 3, 4, 7, 6, 3, 4, 2) | 0.500 hr |
| PF-05212384+Irinotecan: Arm C3 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 0 Day -14 and Cycle 1 Day 15 for Arm D | Cycle 1 Day 15 (N=5, 3, 4, 6, 5, 1, 4, 1) | 0.500 hr |
Secondary
Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C
Time frame: Cycle 1 Day 2 and Cycle 1 Day 16: Pre-dose and 0.5, 1, 2, 4, 6, 8, 24, 72, and 120 hours post-dose.
Population: Enrolled participants treated who had at least 1 of the PK parameters of interest estimated. N=number of participants contributing to the summary statistics.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 1.30 hour (hr) |
| PF-04691502+PF-0325901: Arm A1 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 1.00 hour (hr) |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 0.992 hour (hr) |
| PF-04691502+PF 0325901: Arm A2 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 1.02 hour (hr) |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 0.992 hour (hr) |
| PF-04691502+PF 0325901: Arm A4 (Stage1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 0.734 hour (hr) |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 2 (N=2, 6, 4, 30) | 0.500 hour (hr) |
| PF-04691502+Irinotecan: Arm B1 (Stage 1) | Time to Reach Maximum Plasma Concentration (Tmax) for PF-05212384 on Cycle 1 Day 2 and Day 16 for Arm C | Cycle 1 Day 16 (N=3, 6, 4, 28) | 0.525 hour (hr) |