Neoplasms
Conditions
Keywords
ADC, PF-06647020, solid tumors, tumors, neoplasm metastasis, TNBC, triple negative breast cancer, NSCLC, non small cell lung cancer, advanced metastatic breast cancer, ovarian cancer, OVCA
Brief summary
To assess the safety and tolerability at increasing dose levels of PF-06647020 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Interventions
Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined. Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
combination drug used for drug-drug interaction sub-study
Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined. Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1.
Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
Sponsors
Study design
Eligibility
Inclusion criteria
Q2W Inclusion Criteria: * Diagnosis of platinum resistant or refractory OVCA having received 2 or fewer prior lines, or recurrent advanced NSCLC having received 3 or fewer prior lines * Performance Status of 0, 1, or 2 * Adequate bone marrow, kidney, and liver function Q2W
Exclusion criteria
* OVCA pts excluded with any of the following: non-epithelial, including malignant mixed mullerian tumors, unresolved bowel obstruction * Brain metastases requiring steroids * Major surgery, radiation therapy, or systemic anti-cancer therapy within 4 weeks of study treatment start * Active and clinically significant bacterial, fungal, or viral infection Q3W Inclusion Criteria: * Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for whom no standard therapy is available * Performance Status of 0 or 1 * Adequate bone marrow, kidney, and liver function * Part 2 includes ovarian cancer, target expressing triple negative breast cancer and non small cell lung cancer patients Q3W
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen | First Cycle, Day 1 up to Day 21 | A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 anemia; Grade \>=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade \>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin \>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. |
| Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months) | A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. |
| Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. |
| Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | From baseline to end of treatment (approximately 32 months). | Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets. |
| Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | From baseline to end of treatment (approximately 32 months). | Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia. |
| Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen | From baseline to end of treatment (approximately 32 months). | Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above. |
| Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen | From baseline to end of treatment (approximately 32 months). | Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time. |
| Number of Participants With DLTs - Q2W Regimen | First cycle, Day 1 up to Day 28 | A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay \>14 days because of hematologic AE; (2) Hepatic: including Grade\>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST\>=3.0 x ULN concurrent with elevation in bilirubin\>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade \>=3 headache lasting \>48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days. |
| Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) | From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months) | 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. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. |
| Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) | From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months) | A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. |
| Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months) | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity. |
| Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | From baseline to end of treatment (approximately 19 months). | Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia. |
| Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | From baseline to end of treatment (approximately 19 months). | Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase. |
| Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen | Baseline and Day 1 of Cycle 1 | Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above. |
| Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen | From baseline to end of treatment (approximately 19 months). | Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUCtau for hu6M024 mAb - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method. |
| Cmax for hu6M024 mAb - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data. |
| t1/2 for hu6M024 mAb - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. |
| Rac for hu6M024 mAb - Q3W Regimen | pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle). | Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose). |
| Tmax for hu6M024 mAb - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence. |
| AUClast for hu6M024 mAb - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method. |
| AUCinf for hu6M024 mAb - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months). | To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020. |
| Percentage of Participants With Objective Response - Q3W Regimen | Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). | Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| t1/2 for hu6M024 mAb - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. |
| Duration of Response - Q3W Regimen | Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). | Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions. |
| Disease Control Rate - Q3W Regimen | Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). | The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Time to Progression - Q3W Regimen | Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). | Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions. |
| Progression Free Survival - Q3W Regimen | Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months). | Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions. |
| Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose. |
| Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose. |
| Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose. |
| Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose. |
| AUCinf(dn) for PF-06380101 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose. |
| AUClast(dn) for PF-06380101 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose. |
| AUCtau(dn) for PF-06380101 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose. |
| Cmax(dn) for PF-06380101 [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose. |
| AUCinf(dn) for hu6M024 mAb [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose. |
| AUClast(dn) for hu6M024 mAb [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose. |
| AUCtau(dn) for hu6M024 mAb [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose. |
| Cmax(dn) for hu6M024 mAb [DDI Sub-Study] | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle). | Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose. |
| AUCtau for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method. |
| Cmax for PF-06647020 -Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data. |
| Vss for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| CL for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). |
| t1/2 for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. |
| Rac for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle). | Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose). |
| Tmax for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence. |
| AUClast for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method. |
| AUCinf for PF-06647020 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| AUCtau for PF-06380101 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method. |
| Cmax for PF-06380101 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data. |
| Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method. |
| Rac for PF-06380101 - Q2W Regimen | pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle). | Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose). |
| Tmax for PF-06380101 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence. |
| AUClast for PF-06380101- Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method. |
| AUCinf for PF-06380101- Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| AUCtau for hu6M024 mAb- Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method. |
| Cmax for hu6M024 mAb -Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data. |
| Rac for hu6M024 mAb - Q2W Regimen | pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle). | Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose). |
| Tmax for hu6M024 mAb - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence. |
| AUClast for hu6M024 mAb - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method. |
| AUCinf for hu6M024 mAb - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen | 2 hours before the first dose up to 30 days after the last dose (approximately 18 months). | To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020. |
| Percentage of Participants With Objective Response - Q2W Regimen | Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). | Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. |
| Duration of Response - Q2W Regimen | Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). | For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions. |
| Disease Control Rate - Q2W Regimen | Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). | The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. |
| Time to Progression - Q2W Regimen | Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). | Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions. |
| Progression Free Survival - Q2W Regimen | Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months). | Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions. |
| t1/2 for PF-06380101 - Q2W Regimen | pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle). | Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. |
| Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data. |
| Clearance (CL) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). |
| Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state. |
| Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. |
| Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle). | Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose). |
| Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence. |
| Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method. |
| Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
| AUCtau for PF-06380101 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method. |
| Cmax for PF-06380101 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data. |
| t1/2 for PF-06380101 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half. |
| Rac for PF-06380101 - Q3W Regimen | pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle). | Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose). |
| Tmax for PF-06380101 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence. |
| AUClast for PF-06380101 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method. |
| AUCinf for PF-06380101 - Q3W Regimen | pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle). | AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. |
Countries
Spain, United States
Participant flow
Pre-assignment details
Once every 3 weeks (Q3W) Regimen: A total of 113 participants were enrolled to study treatments and 1 participant in the PF-06647020 2.1 mg/kg treatment group didn't receive any study treatment. Once every 2 weeks (Q2W) Regimen: A total of 25 participants were enrolled to study treatments and all were treated with study drug.
Participants by arm
| Arm | Count |
|---|---|
| PF-06647020 0.2 mg/kg (Q3W Regimen) Participants received PF-06647020 at 0.2 mg/kg on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 4.8 months. | 2 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) Participants received PF-06647020 at 0.5 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 0.7 months. | 2 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) Participants received PF-06647020 at 1.25 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.5 months. | 2 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) Participants received PF-06647020 at 2.1 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months. | 4 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) Participants received PF-06647020 at 2.8 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 30 months. | 96 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) Participants received PF-06647020 at 3.7 mg/kg on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 8.6 months. | 6 |
| PF-06647020 2.1 mg/kg (Q2W Regimen) Participants received PF-06647020 at 2.1 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 3.2 months. | 3 |
| PF-06647020 2.8 mg/kg (Q2W Regimen) Participants received PF-06647020 at 2.8 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 16.4 months. | 10 |
| PF-06647020 3.2 mg/kg (Q2W Regimen) Participants received PF-06647020 at 3.2 mg/kg on Days 1 and 15 of each 28-day cycle as an IV infusion over approximately 60 minutes on an outpatient basis. Each participant received PF-06647020 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination. The maximum duration of treatment in this arm was approximately 17.1 months. | 12 |
| Total | 137 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 |
|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 13 | 0 | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 | 9 | 1 | 0 | 0 | 0 |
| Overall Study | Other | 0 | 0 | 0 | 2 | 10 | 2 | 2 | 4 | 1 |
| Overall Study | Participant refused further follow-up | 1 | 0 | 0 | 1 | 6 | 0 | 0 | 0 | 3 |
Baseline characteristics
| Characteristic | Total | PF-06647020 2.8 mg/kg (Q2W Regimen) | PF-06647020 2.1 mg/kg (Q2W Regimen) | PF-06647020 3.2 mg/kg (Q2W Regimen) | PF-06647020 2.1 mg/kg (Q3W Regimen) | PF-06647020 1.25 mg/kg (Q3W Regimen) | PF-06647020 0.5 mg/kg (Q3W Regimen) | PF-06647020 2.8 mg/kg (Q3W Regimen) | PF-06647020 3.7 mg/kg (Q3W Regimen) | PF-06647020 0.2 mg/kg (Q3W Regimen) |
|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous Q2W Regimen | 65.4 Years STANDARD_DEVIATION 7.8 | 65.5 Years STANDARD_DEVIATION 8.9 | 64.0 Years STANDARD_DEVIATION 2.6 | 65.6 Years STANDARD_DEVIATION 8 | — | — | — | — | — | — |
| Age, Continuous Q3W Regimen | 58.4 Years STANDARD_DEVIATION 11.6 | — | — | — | 55.0 Years STANDARD_DEVIATION 13.6 | 61.0 Years STANDARD_DEVIATION 2.8 | 57.5 Years STANDARD_DEVIATION 14.8 | 58.1 Years STANDARD_DEVIATION 11.8 | 59.5 Years STANDARD_DEVIATION 8.4 | 73.0 Years STANDARD_DEVIATION 2.8 |
| Age, Customized 18-44 (Q2W Regimen) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 18-44 (Q3W Regimen) | 16 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 16 Participants | 0 Participants | 0 Participants |
| Age, Customized < 18 (Q2W Regimen) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized < 18 (Q3W Regimen) | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 45-64 (Q2W Regimen) | 12 Participants | 5 Participants | 1 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 45-64 (Q3W Regimen) | 59 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 49 Participants | 4 Participants | 0 Participants |
| Age, Customized >= 65 (Q2W Regimen) | 13 Participants | 5 Participants | 2 Participants | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >= 65 (Q3W Regimen) | 37 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 31 Participants | 2 Participants | 2 Participants |
| Body Mass Index (BMI) Continuous Q2W Regimen | 27.2 kg/m^2 STANDARD_DEVIATION 8.7 | 29.9 kg/m^2 STANDARD_DEVIATION 9.1 | 24.9 kg/m^2 STANDARD_DEVIATION 7.1 | 25.6 kg/m^2 STANDARD_DEVIATION 8.8 | — | — | — | — | — | — |
| Body Mass Index (BMI) Continuous Q3W Regimen | 25.5 kg/m^2 STANDARD_DEVIATION 5.5 | — | — | — | 27.6 kg/m^2 STANDARD_DEVIATION 7.7 | 23.6 kg/m^2 STANDARD_DEVIATION 2 | 22.7 kg/m^2 STANDARD_DEVIATION 2.7 | 25.6 kg/m^2 STANDARD_DEVIATION 5.5 | 26.2 kg/m^2 STANDARD_DEVIATION 4.7 | 18.3 kg/m^2 STANDARD_DEVIATION 2 |
| Race (NIH/OMB) Q2W Regimen American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q2W Regimen Asian | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q2W Regimen Black or African American | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q2W Regimen More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q2W Regimen Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q2W Regimen Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q2W Regimen White | 21 Participants | 8 Participants | 2 Participants | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q3W Regimen American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q3W Regimen Asian | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q3W Regimen Black or African American | 6 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 5 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q3W Regimen More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q3W Regimen Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q3W Regimen Unknown or Not Reported | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Q3W Regimen White | 103 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 2 Participants | 88 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Q2W Regimen Female | 24 Participants | 10 Participants | 3 Participants | 11 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Q2W Regimen Male | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Q3W Regimen Female | 92 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants | 1 Participants | 1 Participants | 80 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Q3W Regimen Male | 20 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 16 Participants | 1 Participants | 0 Participants |
| Weight Continuous Q2W Regimen | 72.3 kilogram (kg) STANDARD_DEVIATION 23.4 | 78.1 kilogram (kg) STANDARD_DEVIATION 25.5 | 68.4 kilogram (kg) STANDARD_DEVIATION 23.8 | 68.3 kilogram (kg) STANDARD_DEVIATION 22.5 | — | — | — | — | — | — |
| Weight Continuous Q3W Regimen | 70.0 kilogram (kg) STANDARD_DEVIATION 16.6 | — | — | — | 80.7 kilogram (kg) STANDARD_DEVIATION 27.3 | 68.7 kilogram (kg) STANDARD_DEVIATION 5.2 | 68.8 kilogram (kg) STANDARD_DEVIATION 21.9 | 69.9 kilogram (kg) STANDARD_DEVIATION 16.4 | 72.2 kilogram (kg) STANDARD_DEVIATION 14.2 | 49.2 kilogram (kg) STANDARD_DEVIATION 10.2 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 4 | 13 / 96 | 0 / 6 | 0 / 3 | 0 / 10 | 2 / 12 |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 2 / 2 | 4 / 4 | 93 / 96 | 6 / 6 | 3 / 3 | 10 / 10 | 12 / 12 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 2 | 1 / 4 | 33 / 96 | 2 / 6 | 1 / 3 | 4 / 10 | 7 / 12 |
Outcome results
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hyponatremia, hypomagnesemia, hypoalbuminemia, hypocalcemia, hypophosphatemia, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase.
Time frame: From baseline to end of treatment (approximately 19 months).
Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Alanine aminotransferase | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Aspartate aminotransferase | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypomagnesemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Alkaline phosphatase | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypokalemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypoalbuminemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypocalcemia | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hyponatremia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypophosphatemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypocalcemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Alanine aminotransferase | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypokalemia | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypophosphatemia | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Aspartate aminotransferase | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypoalbuminemia | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hyponatremia | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Alkaline phosphatase | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypomagnesemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Alkaline phosphatase | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypokalemia | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hyponatremia | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypomagnesemia | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypocalcemia | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypophosphatemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Alanine aminotransferase | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Aspartate aminotransferase | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q2W Regimen | Hypoalbuminemia | 1 Participants |
Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced chemistry laboratory test abnormalities were summarized according to worst toxicity grade observed for each chemistry laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with chemistry laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: hypokalemia, hypophosphatemia, aspartate aminotransferase, hyperglycemia, alkaline phosphatase, hyponatremia, alanine aminotransferase, hypoalbuminemia, total bilirubin, hypercalcemia, hypomagnesemia , creatinine, gamma glutamyl transferase, hypocalcemia.
Time frame: From baseline to end of treatment (approximately 32 months).
Population: All participants enrolled in Q3W who received at least 1 full or partial dose of study medication and had at least 1 observation of the given chemistry laboratory test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alkaline phosphatase | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyperglycemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Aspartate aminotransferase | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Creatinine | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypercalcemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Total bilirubin | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Gamma glutamyl transferase | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypoalbuminemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypocalcemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypomagnesemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alanine aminotransferase | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyponatremia | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypokalemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypophosphatemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypercalcemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyperglycemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alanine aminotransferase | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypophosphatemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Aspartate aminotransferase | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Creatinine | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypocalcemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypokalemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Total bilirubin | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alkaline phosphatase | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyponatremia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Gamma glutamyl transferase | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypomagnesemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypoalbuminemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypercalcemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Creatinine | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Gamma glutamyl transferase | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypocalcemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypophosphatemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Aspartate aminotransferase | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyperglycemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alkaline phosphatase | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyponatremia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alanine aminotransferase | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypoalbuminemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Total bilirubin | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypokalemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypomagnesemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alanine aminotransferase | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alkaline phosphatase | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Creatinine | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypophosphatemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Gamma glutamyl transferase | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypomagnesemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypoalbuminemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyponatremia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Total bilirubin | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyperglycemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Aspartate aminotransferase | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypocalcemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypercalcemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypokalemia | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypophosphatemia | 8 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Aspartate aminotransferase | 6 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alkaline phosphatase | 6 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypocalcemia | 1 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypokalemia | 8 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyponatremia | 4 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alanine aminotransferase | 4 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Gamma glutamyl transferase | 1 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypoalbuminemia | 3 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Creatinine | 1 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypomagnesemia | 2 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Total bilirubin | 2 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypercalcemia | 2 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyperglycemia | 6 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Total bilirubin | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alanine aminotransferase | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Aspartate aminotransferase | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypomagnesemia | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Gamma glutamyl transferase | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyperglycemia | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hyponatremia | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypophosphatemia | 1 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypokalemia | 1 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Creatinine | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypercalcemia | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypocalcemia | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Hypoalbuminemia | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Chemistry Laboratory Abnormalities (All Cycles) - Q3W Regimen | Alkaline phosphatase | 0 Participants |
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: prothrombin time international normalized ratio.
Time frame: From baseline to end of treatment (approximately 19 months).
Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q2W Regimen | 1 Participants |
Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced coagulation laboratory test abnormalities were summarized according to worst toxicity grade observed for each coagulation laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with coagulation laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameter: partial thromboplastin time.
Time frame: From baseline to end of treatment (approximately 32 months).
Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given coagulation laboratory test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen | 1 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Coagulation Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
Number of Participants With DLTs - Q2W Regimen
A DLT was any of the following AEs in the first cycle of treatment (within 28 days of first dose or until participant received second infusion if there were treatment delayed) in the single agent dose escalation. (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 thrombocytopenia; treatment delay \>14 days because of hematologic AE; (2) Hepatic: including Grade\>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; ALT or AST\>=3.0 x ULN concurrent with elevation in bilirubin\>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. Grade \>=3 headache lasting \>48 hours in presence of supportive care. A participant was on study for at least 28 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 28 days.
Time frame: First cycle, Day 1 up to Day 28
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post baseline disease assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With DLTs - Q2W Regimen | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With DLTs - Q2W Regimen | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With DLTs - Q2W Regimen | 2 Participants |
Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen
A DLT was any of the following adverse events(AEs) in the first cycle of treatment (within 21 days of first dose or until participant received second infusion if there were treatment delays). (1)Hematologic: including Grade 4 neutropenia lasting \>7 days; Febrile neutropenia; Grade \>=3 neutropenic infection; Grade 4 anemia; Grade \>=3 thrombocytopenia with clinically significant bleeding. (2) Hepatic, including Grade \>=3 serum bilirubin, hepatic transaminase or alkaline phosphatase; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>=3.0 x upper limit of normal (ULN) concurrent with elevation in bilirubin \>=2.0 x ULN; (3) Grade \>=3 non-hematologic, non-hepatic major organ toxicities; delayed by \>2 weeks in receiving the next scheduled cycle due to persisting toxicities attributable to PF-06647020. A participant was on study for at least 21 days to be evaluable for DLT observation, and could be replaced if they terminated study participation earlier than 21 days.
Time frame: First Cycle, Day 1 up to Day 21
Population: Participants enrolled in the dose escalation phase in Q3W regimen who received at least 1 dose of study medication and who did not have major treatment deviations during first cycle with a baseline disease assessment and at least 1 post-baseline disease assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Dose Limiting Toxicities (DLTs) - Q3W Regimen | 2 Participants |
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia.
Time frame: From baseline to end of treatment (approximately 19 months).
Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Absolute neutrophils | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Lymphopenia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | White blood cells | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Anemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Anemia | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Absolute neutrophils | 3 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | White blood cells | 2 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Lymphopenia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Anemia | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Lymphopenia | 4 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | White blood cells | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q2W Regimen | Absolute neutrophils | 5 Participants |
Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced hematology laboratory test abnormalities were summarized according to worst toxicity grade observed for each hematology laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with hematology laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above, including the following parameters: absolute neutrophils, lymphopenia, white blood cell, anemia, platelets.
Time frame: From baseline to end of treatment (approximately 32 months).
Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given hematology laboratory test.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Platelets | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | White blood cells | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Anemia | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Lymphopenia | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Absolute neutrophils | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Platelets | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Absolute neutrophils | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Lymphopenia | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | White blood cells | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Anemia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Platelets | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | White blood cells | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Lymphopenia | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Absolute neutrophils | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Anemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | White blood cells | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Lymphopenia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Platelets | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Anemia | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Absolute neutrophils | 1 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Lymphopenia | 21 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Absolute neutrophils | 28 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Platelets | 2 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Anemia | 2 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | White blood cells | 18 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Platelets | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Absolute neutrophils | 2 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | White blood cells | 1 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Anemia | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Hematology Laboratory Abnormalities (All Cycles) - Q3W Regimen | Lymphopenia | 2 Participants |
Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | SAEs | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | AEs | 2 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | AEs | 2 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | SAEs | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | AEs | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | SAEs | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | AEs | 4 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | SAEs | 1 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | AEs | 96 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | SAEs | 33 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | SAEs | 2 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent Adverse Events (AEs) - Q3W Regimen (All-Causality) | AEs | 6 Participants |
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the NCI CTCAE version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 2 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 3 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 3 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 4 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 4 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 2 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 5 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 7 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 5 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 6 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q2W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related)
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication. All AEs were graded by the investigator according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 AEs are mild AEs; Grade 2 AEs are moderate AEs; Grade 3 AEs are severe AEs, Grade 4 AEs are life-threatening consequences and Grade 5 AEs are deaths related to AEs. Each AE was counted once for the participant in the most severe severity.
Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 0 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 2 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 1 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 1 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 1 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 2 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 1 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 3 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 21 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 49 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 18 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 12 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 6 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 28 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 9 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 23 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 14 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (all-causality) | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (treatment-related) | 1 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (treatment-related) | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 5 (all-causality) | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (all-causality) | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (all-causality) | 5 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 3 (treatment-related) | 3 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 2 (all-causality) | 1 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 1 (treatment-related) | 1 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (treatment-related) | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Missing or Unknown (all-causality) | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs Categorized by Seriousness - Q3W Regimen (All-Causality and Treatment-Related) | Grade 4 (treatment-related) | 0 Participants |
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality)
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. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) | AEs | 3 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) | SAEs | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) | AEs | 10 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) | SAEs | 4 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) | AEs | 12 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (All-Causality) | SAEs | 7 Participants |
Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 19 months)
Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) | AEs | 3 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) | SAEs | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) | AEs | 10 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) | SAEs | 2 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) | AEs | 12 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q2W Regimen (Treatment-Related) | SAEs | 2 Participants |
Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related)
A treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study medication.
Time frame: From the time the participant took the first dose of study medication through the participant's last visit. (approximately 32 months)
Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | AEs | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | SAEs | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | AEs | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | SAEs | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | SAEs | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | AEs | 1 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | AEs | 4 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | SAEs | 1 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | AEs | 84 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | SAEs | 9 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | SAEs | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Treatment-Emergent AEs - Q3W Regimen (Treatment-Related) | AEs | 5 Participants |
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Time frame: Baseline and Day 1 of Cycle 1
Population: All participants enrolled in Q2W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q2W Regimen | 0 Participants |
Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen
Participants who experienced urinalysis laboratory test abnormalities were summarized according to worst toxicity grade observed for each urinalysis laboratory test. Laboratory abnormalities were graded by NCI CTCAE version 4.03. This outcome measure calculated the number of participants with urinalysis laboratory abnormalities that were shifted from \<=Grade 2 at baseline to Grade 3 or above.
Time frame: From baseline to end of treatment (approximately 32 months).
Population: All participants enrolled in Q3W regimen who received at least 1 full or partial dose of study medication and had at least 1 observation of the given urinalysis laboratory test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Urinalysis Laboratory Abnormalities (All Cycles) - Q3W Regimen | 0 Participants |
Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06647020 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 4312 µg•hr/mL | Geometric Coefficient of Variation 102 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 4637 µg•hr/mL | Geometric Coefficient of Variation 30 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 4829 µg•hr/mL | Geometric Coefficient of Variation 63 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 6086 µg•hr/mL | Geometric Coefficient of Variation 62 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 7052 µg•hr/mL | Geometric Coefficient of Variation 81 |
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 4157 µg•hr/mL | Geometric Coefficient of Variation 98 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 4570 µg•hr/mL | Geometric Coefficient of Variation 30 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 4674 µg•hr/mL | Geometric Coefficient of Variation 63 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 5428 µg•hr/mL | Geometric Coefficient of Variation 83 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 4450 µg•hr/mL | Geometric Coefficient of Variation 198 |
Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA microgram•hour/milliliter (µg•hr/mL) | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA microgram•hour/milliliter (µg•hr/mL) | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA microgram•hour/milliliter (µg•hr/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA microgram•hour/milliliter (µg•hr/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA microgram•hour/milliliter (µg•hr/mL) | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 4201 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 95 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 4570 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 30 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 4782 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 61 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 5834 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 60 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 6929 microgram•hour/milliliter (µg•hr/mL) | Geometric Coefficient of Variation 80 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA microgram•hour/milliliter (µg•hr/mL) | — |
AUCinf(dn) for hu6M024 mAb [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf(dn) for hu6M024 mAb [DDI Sub-Study] | 31.94 µg•hr/mL/mg | Geometric Coefficient of Variation 45 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf(dn) for hu6M024 mAb [DDI Sub-Study] | 25.92 µg•hr/mL/mg | Geometric Coefficient of Variation 46 |
AUCinf(dn) for PF-06380101 [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf(dn) for PF-06380101 [DDI Sub-Study] | 5.787 ng•hr/mL/mg | Geometric Coefficient of Variation 116 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf(dn) for PF-06380101 [DDI Sub-Study] | 5.275 ng•hr/mL/mg | Geometric Coefficient of Variation 123 |
AUCinf for hu6M024 mAb - Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 7742 µg•hr/mL | Geometric Coefficient of Variation 47 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 10950 µg•hr/mL | Geometric Coefficient of Variation 22 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 7411 µg•hr/mL | Geometric Coefficient of Variation 48 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 8275 µg•hr/mL | Geometric Coefficient of Variation 44 |
AUCinf for hu6M024 mAb - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for hu6M024 mAb was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 6517 µg•hr/mL | Geometric Coefficient of Variation 156 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 7189 µg•hr/mL | Geometric Coefficient of Variation 32 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 5608 µg•hr/mL | Geometric Coefficient of Variation 65 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 6191 µg•hr/mL | Geometric Coefficient of Variation 94 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCinf for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 8760 µg•hr/mL | Geometric Coefficient of Variation 80 |
AUCinf for PF-06380101- Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for PF-06380101- Q2W Regimen | Cycle 1, Single Dose | 584.4 ng•hr/mL | Geometric Coefficient of Variation 11 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for PF-06380101- Q2W Regimen | Cycle 3, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for PF-06380101- Q2W Regimen | Cycle 1, Single Dose | 888.5 ng•hr/mL | Geometric Coefficient of Variation 54 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for PF-06380101- Q2W Regimen | Cycle 3, Multiple Dose | 738.8 ng•hr/mL | Geometric Coefficient of Variation 69 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for PF-06380101- Q2W Regimen | Cycle 1, Single Dose | 763.2 ng•hr/mL | Geometric Coefficient of Variation 62 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for PF-06380101- Q2W Regimen | Cycle 3, Multiple Dose | 617.9 ng•hr/mL | Geometric Coefficient of Variation 32 |
AUCinf for PF-06380101 - Q3W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf for PF-06380101 was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA ng•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA ng•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA ng•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 851.4 ng•hr/mL | Geometric Coefficient of Variation 45 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 422.9 ng•hr/mL | Geometric Coefficient of Variation 105 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 812.2 ng•hr/mL | Geometric Coefficient of Variation 68 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 645.2 ng•hr/mL | Geometric Coefficient of Variation 48 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCinf for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 1020 ng•hr/mL | Geometric Coefficient of Variation 95 |
AUCinf for PF-06647020 - Q2W Regimen
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf was calculated as AUClast + (Clast\*/kel), where AUClast was the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration, Clast\* was the predicted serum concentration at the last quantifiable time point estimated from the log-linear regression analysis. kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCinf for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 6798 µg•hr/mL | Geometric Coefficient of Variation 41 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCinf for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 10570 µg•hr/mL | Geometric Coefficient of Variation 22 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 6535 µg•hr/mL | Geometric Coefficient of Variation 46 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCinf for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 7445 µg•hr/mL | Geometric Coefficient of Variation 44 |
AUClast(dn) for hu6M024 mAb [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast(dn) for hu6M024 mAb [DDI Sub-Study] | 31.30 µg•hr/mL/mg | Geometric Coefficient of Variation 44 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast(dn) for hu6M024 mAb [DDI Sub-Study] | 26.30 µg•hr/mL/mg | Geometric Coefficient of Variation 48 |
AUClast(dn) for PF-06380101 [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast(dn) for PF-06380101 [DDI Sub-Study] | 5.681 ng•hr/mL/mg | Geometric Coefficient of Variation 112 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast(dn) for PF-06380101 [DDI Sub-Study] | 5.089 ng•hr/mL/mg | Geometric Coefficient of Variation 128 |
AUClast for hu6M024 mAb - Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 4103 µg•hr/mL | Geometric Coefficient of Variation 52 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 7368 µg•hr/mL | Geometric Coefficient of Variation 46 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 10460 µg•hr/mL | Geometric Coefficient of Variation 24 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 6949 µg•hr/mL | Geometric Coefficient of Variation 45 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 8555 µg•hr/mL | Geometric Coefficient of Variation 41 |
AUClast for hu6M024 mAb - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for hu6M024 mAb was determined using linear/log trapezoidal method.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 6969 µg•hr/mL | Geometric Coefficient of Variation 32 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 6127 µg•hr/mL | Geometric Coefficient of Variation 147 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 5449 µg•hr/mL | Geometric Coefficient of Variation 64 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 5885 µg•hr/mL | Geometric Coefficient of Variation 97 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUClast for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 5247 µg•hr/mL | Geometric Coefficient of Variation 221 |
AUClast for PF-06380101- Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for PF-06380101- Q2W Regimen | Cycle 1, Single Dose | 569.9 ng•hr/mL | Geometric Coefficient of Variation 12 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for PF-06380101- Q2W Regimen | Cycle 3, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for PF-06380101- Q2W Regimen | Cycle 1, Single Dose | 866.0 ng•hr/mL | Geometric Coefficient of Variation 53 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for PF-06380101- Q2W Regimen | Cycle 3, Multiple Dose | 728.9 ng•hr/mL | Geometric Coefficient of Variation 60 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for PF-06380101- Q2W Regimen | Cycle 1, Single Dose | 743.5 ng•hr/mL | Geometric Coefficient of Variation 63 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for PF-06380101- Q2W Regimen | Cycle 3, Multiple Dose | 593.3 ng•hr/mL | Geometric Coefficient of Variation 33 |
AUClast for PF-06380101 - Q3W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06380101 was determined using linear/log trapezoidal method.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA ng•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA ng•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA ng•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 844.6 ng•hr/mL | Geometric Coefficient of Variation 46 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 418.5 ng•hr/mL | Geometric Coefficient of Variation 106 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 799.3 ng•hr/mL | Geometric Coefficient of Variation 68 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 643.6 ng•hr/mL | Geometric Coefficient of Variation 48 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUClast for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 490.5 ng•hr/mL | Geometric Coefficient of Variation 615 |
AUClast for PF-06647020 - Q2W Regimen
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast for PF-06647020 was determined using linear/log trapezoidal method.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 3641 µg•hr/mL | Geometric Coefficient of Variation 62 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUClast for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 6490 µg•hr/mL | Geometric Coefficient of Variation 39 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUClast for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 9864 µg•hr/mL | Geometric Coefficient of Variation 20 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 6342 µg•hr/mL | Geometric Coefficient of Variation 46 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUClast for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 7000 µg•hr/mL | Geometric Coefficient of Variation 43 |
AUCtau(dn) for hu6M024 mAb [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau(dn) for hu6M024 mAb [DDI Sub-Study] | 31.29 µg•hr/mL/mg | Geometric Coefficient of Variation 44 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau(dn) for hu6M024 mAb [DDI Sub-Study] | 26.96 µg•hr/mL/mg | Geometric Coefficient of Variation 46 |
AUCtau(dn) for PF-06380101 [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau(dn) for PF-06380101 [DDI Sub-Study] | 5.746 ng•hr/mL/mg | Geometric Coefficient of Variation 115 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau(dn) for PF-06380101 [DDI Sub-Study] | 5.239 ng•hr/mL/mg | Geometric Coefficient of Variation 123 |
AUCtau for hu6M024 mAb- Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mA was determined using linear/log trapezoidal method.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for hu6M024 mAb- Q2W Regimen | Cycle 3, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for hu6M024 mAb- Q2W Regimen | Cycle 1, Single Dose | 4089 µg•hr/mL | Geometric Coefficient of Variation 52 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb- Q2W Regimen | Cycle 1, Single Dose | 7325 µg•hr/mL | Geometric Coefficient of Variation 47 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb- Q2W Regimen | Cycle 3, Multiple Dose | 10440 µg•hr/mL | Geometric Coefficient of Variation 25 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb- Q2W Regimen | Cycle 1, Single Dose | 6911 µg•hr/mL | Geometric Coefficient of Variation 44 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb- Q2W Regimen | Cycle 3, Multiple Dose | 8432 µg•hr/mL | Geometric Coefficient of Variation 42 |
AUCtau for hu6M024 mAb - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for hu6M024 mAb was determined using linear/log trapezoidal method.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg•hr/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 6968 µg•hr/mL | Geometric Coefficient of Variation 32 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 6122 µg•hr/mL | Geometric Coefficient of Variation 145 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 5562 µg•hr/mL | Geometric Coefficient of Variation 62 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 6210 µg•hr/mL | Geometric Coefficient of Variation 80 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCtau for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 8451 µg•hr/mL | Geometric Coefficient of Variation 78 |
AUCtau for PF-06380101 - Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 568.9 ng•hr/mL | Geometric Coefficient of Variation 12 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | NA ng•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 731.5 ng•hr/mL | Geometric Coefficient of Variation 61 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 860.3 ng•hr/mL | Geometric Coefficient of Variation 52 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 740.5 ng•hr/mL | Geometric Coefficient of Variation 62 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 589.8 ng•hr/mL | Geometric Coefficient of Variation 33 |
AUCtau for PF-06380101 - Q3W Regimen
Tau refers to the dosing interval and it equals to 504 hours for the Q3W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06380101 was determined using linear/log trapezoidal method.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA nanogram•hour/milliliter (ng•hr/mL) | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA nanogram•hour/milliliter (ng•hr/mL) | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA nanogram•hour/milliliter (ng•hr/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA nanogram•hour/milliliter (ng•hr/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA nanogram•hour/milliliter (ng•hr/mL) | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 844.6 nanogram•hour/milliliter (ng•hr/mL) | Geometric Coefficient of Variation 46 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 418.3 nanogram•hour/milliliter (ng•hr/mL) | Geometric Coefficient of Variation 106 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 803.9 nanogram•hour/milliliter (ng•hr/mL) | Geometric Coefficient of Variation 68 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 647.9 nanogram•hour/milliliter (ng•hr/mL) | Geometric Coefficient of Variation 46 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA nanogram•hour/milliliter (ng•hr/mL) | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | AUCtau for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 1022 nanogram•hour/milliliter (ng•hr/mL) | Geometric Coefficient of Variation 78 |
AUCtau for PF-06647020 - Q2W Regimen
Tau refers to the dosing interval and it equals to 336 hours for the Q2W dosing. AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau for PF-06647020 was determined using linear/log trapezoidal method.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 3627 µg•hr/mL | Geometric Coefficient of Variation 62 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | AUCtau for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | NA µg•hr/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 6541 µg•hr/mL | Geometric Coefficient of Variation 38 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | AUCtau for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 9858 µg•hr/mL | Geometric Coefficient of Variation 21 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 6319 µg•hr/mL | Geometric Coefficient of Variation 45 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | AUCtau for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 6933 µg•hr/mL | Geometric Coefficient of Variation 43 |
Clearance (CL) for PF-06647020 - Q3W Regimen
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing).
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA Liter/hour (L/hr) | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA Liter/hour (L/hr) | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA Liter/hour (L/hr) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA Liter/hour (L/hr) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA Liter/hour (L/hr) | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 0.03464 Liter/hour (L/hr) | Geometric Coefficient of Variation 27 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 0.03640 Liter/hour (L/hr) | Geometric Coefficient of Variation 42 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 0.03956 Liter/hour (L/hr) | Geometric Coefficient of Variation 60 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 0.03121 Liter/hour (L/hr) | Geometric Coefficient of Variation 60 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA Liter/hour (L/hr) | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Clearance (CL) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 0.03694 Liter/hour (L/hr) | Geometric Coefficient of Variation 72 |
CL for PF-06647020 - Q2W Regimen
Clearance (CL) is a quantitative measure of the rate at which a drug substance is removed from the body. Clearance for PF-06647020 was calculated as dose/AUCinf for single dose and dose/AUCtau for multiple dose, where AUCinf was the area under the serum concentration-time profile from time 0 extrapolated to infinite time and AUCtau was the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing).
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | CL for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | NA L/hr | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | CL for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | NA L/hr | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | CL for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 0.03075 L/hr | Geometric Coefficient of Variation 49 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | CL for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 0.02044 L/hr | Geometric Coefficient of Variation 25 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | CL for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 0.03238 L/hr | Geometric Coefficient of Variation 39 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | CL for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 0.02688 L/hr | Geometric Coefficient of Variation 35 |
Cmax(dn) for hu6M024 mAb [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax(dn) for hu6M024 mAb [DDI Sub-Study] | 0.4378 µg/mL/mg | Geometric Coefficient of Variation 59 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax(dn) for hu6M024 mAb [DDI Sub-Study] | 0.3885 µg/mL/mg | Geometric Coefficient of Variation 37 |
Cmax(dn) for PF-06380101 [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax(dn) for PF-06380101 [DDI Sub-Study] | 0.04336 ng/mL/mg | Geometric Coefficient of Variation 113 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax(dn) for PF-06380101 [DDI Sub-Study] | 0.04436 ng/mL/mg | Geometric Coefficient of Variation 118 |
Cmax for hu6M024 mAb -Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for hu6M024 mAb -Q2W Regimen | Cycle 1, Single Dose | 72.04 µg/mL | Geometric Coefficient of Variation 23 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for hu6M024 mAb -Q2W Regimen | Cycle 3, Multiple Dose | NA µg/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb -Q2W Regimen | Cycle 1, Single Dose | 102.1 µg/mL | Geometric Coefficient of Variation 38 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb -Q2W Regimen | Cycle 3, Multiple Dose | 106.6 µg/mL | Geometric Coefficient of Variation 37 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb -Q2W Regimen | Cycle 1, Single Dose | 86.26 µg/mL | Geometric Coefficient of Variation 27 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb -Q2W Regimen | Cycle 3, Multiple Dose | 89.66 µg/mL | Geometric Coefficient of Variation 33 |
Cmax for hu6M024 mAb - Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for hu6M024 mAb was observed directly from data.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg/mL | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA µg/mL | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg/mL | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 77.76 µg/mL | Geometric Coefficient of Variation 76 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 83.33 µg/mL | Geometric Coefficient of Variation 20 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 84.83 µg/mL | Geometric Coefficient of Variation 43 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 82.33 µg/mL | Geometric Coefficient of Variation 40 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA µg/mL | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Cmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 99.37 µg/mL | Geometric Coefficient of Variation 47 |
Cmax for PF-06380101 - Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 6.084 ng/mL | Geometric Coefficient of Variation 59 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | NA ng/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 6.665 ng/mL | Geometric Coefficient of Variation 49 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 4.857 ng/mL | Geometric Coefficient of Variation 66 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 5.779 ng/mL | Geometric Coefficient of Variation 59 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 4.248 ng/mL | Geometric Coefficient of Variation 34 |
Cmax for PF-06380101 - Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06380101 was observed directly from data.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA nanogram/milliliter (ng/mL) | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA nanogram/milliliter (ng/mL) | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA nanogram/milliliter (ng/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA nanogram/milliliter (ng/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA nanogram/milliliter (ng/mL) | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 7.156 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 3.379 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 84 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 6.934 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 69 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 5.746 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 60 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA nanogram/milliliter (ng/mL) | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Cmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 7.660 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 47 |
Cmax for PF-06647020 -Q2W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for PF-06647020 -Q2W Regimen | Cycle 1, Single Dose | 97.79 µg/mL | Geometric Coefficient of Variation 14 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Cmax for PF-06647020 -Q2W Regimen | Cycle 3, Multiple Dose | NA µg/mL | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for PF-06647020 -Q2W Regimen | Cycle 1, Single Dose | 99.69 µg/mL | Geometric Coefficient of Variation 32 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Cmax for PF-06647020 -Q2W Regimen | Cycle 3, Multiple Dose | 114.7 µg/mL | Geometric Coefficient of Variation 26 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for PF-06647020 -Q2W Regimen | Cycle 1, Single Dose | 90.28 µg/mL | Geometric Coefficient of Variation 32 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Cmax for PF-06647020 -Q2W Regimen | Cycle 3, Multiple Dose | 81.91 µg/mL | Geometric Coefficient of Variation 34 |
Disease Control Rate - Q2W Regimen
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR or SD according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Disease Control Rate - Q2W Regimen | 50 Percentage of participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Disease Control Rate - Q2W Regimen | 84.2 Percentage of participants |
Disease Control Rate - Q3W Regimen
The disease control rate (DCR) was defined as the percentage of participants with a confirmed CR, PR, non-CR/non-PD or stable disease (SD) according to the appropriate analysis set. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Disease Control Rate - Q3W Regimen | 56.0 Percentage of participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Disease Control Rate - Q3W Regimen | 72.7 Percentage of participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Disease Control Rate - Q3W Regimen | 48.3 Percentage of participants |
Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study]
AUCinf is the area under the serum concentration-time profile from time 0 extrapolated to infinite time. AUCinf(dn) was defined as dose normalized AUCinf and calculated as AUCinf/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: The drug-drug interaction (DDI) sub-study was determined to evaluate the effect of multiple dose fluconazole on the PK of PF-06380101 (payload), when fluconazole was co-administered with PF-06647020. The analysis population included participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study] | 29.56 µg•hr/mL/mg | Geometric Coefficient of Variation 46 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Dose Normalized AUCinf [AUCinf(dn)] for PF-06647020 [DDI Sub-Study] | 23.47 µg•hr/mL/mg | Geometric Coefficient of Variation 53 |
Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study]
AUClast is the area under the serum concentration-time profile from time 0 to the time of the last quantifiable concentration. AUClast(dn) was defined as dose normalized AUClast and calculated as AUClast/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study] | 31.51 µg•hr/mL/mg | Geometric Coefficient of Variation 51 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Dose Normalized AUClast [AUClast(dn)] for PF-06647020 [DDI Sub-Study] | 24.34 µg•hr/mL/mg | Geometric Coefficient of Variation 50 |
Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study]
AUCtau is the area under the concentration-time profile from time 0 to time tau. AUCtau(dn) was defined as dose normalized AUCtau and calculated as AUCtau/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study] | 29.25 µg•hr/mL/mg | Geometric Coefficient of Variation 46 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Dose Normalized AUCtau [AUCtau(dn)] for PF-06647020 [DDI Sub-Study] | 24.85 µg•hr/mL/mg | Geometric Coefficient of Variation 48 |
Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study]
Cmax is maximum observed serum concentration. Cmax(dn) was defined as dose normalized Cmax and calculated as Cmax/dose.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 2 (21 days cycle).
Population: Participants who participated in the DDI sub-study, and had at least one of the study required PK samples.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study] | 0.5010 µg/mL/mg | Geometric Coefficient of Variation 49 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Dose Normalized Cmax [Cmax(dn)] for PF-06647020 [DDI Sub-Study] | 0.4425 µg/mL/mg | Geometric Coefficient of Variation 39 |
Duration of Response - Q2W Regimen
For participants with an objective response, duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of PD or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Duration of Response - Q2W Regimen | NA month |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Duration of Response - Q2W Regimen | 6.5 month |
Duration of Response - Q3W Regimen
Duration of response (DoR) was the time from first documentation of PR or CR to date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment. DoR was only for the subset participants with an objective response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Duration of Response - Q3W Regimen | 5.7 month |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Duration of Response - Q3W Regimen | 4.2 month |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Duration of Response - Q3W Regimen | 4.3 month |
Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen
Cmax is maximum observed serum concentration. Cmax for PF-06647020 was observed directly from data.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 4, Multiple Dose | NA microgram/milliliter (µg/mL) | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 1, Single Dose | NA microgram/milliliter (µg/mL) | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 1, Single Dose | NA microgram/milliliter (µg/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 1, Single Dose | NA microgram/milliliter (µg/mL) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 4, Multiple Dose | NA microgram/milliliter (µg/mL) | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 1, Single Dose | 65.77 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 25 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 4, Multiple Dose | 55.41 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 53 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 1, Single Dose | 79.77 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 45 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 4, Multiple Dose | 92.94 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 50 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 4, Multiple Dose | NA microgram/milliliter (µg/mL) | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Maximum Observed Serum Concentration (Cmax) for PF-06647020 -Q3W Regimen | Cycle 1, Single Dose | 96.11 microgram/milliliter (µg/mL) | Geometric Coefficient of Variation 47 |
Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
Time frame: 2 hours before the first dose up to 30 days after the last dose (approximately 18 months).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen | Overall incidence of ADA | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen | Overall incidence of NAb | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen | Overall incidence of ADA | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen | Overall incidence of NAb | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen | Overall incidence of ADA | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With ADA and NAb of PF-06647020 - Q2W Regimen | Overall incidence of NAb | 0 Participants |
Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen
To evaluate the immunogenicity as measured by presence of ADA and NAb in participants treated with PF-06647020.
Time frame: Prior to the start of treatment on Day 1 of Cycle 1 up to end of treatment (approximately 31 months).
Population: All participants enrolled in Q3W regimen who received at least 1 dose of study treatment and had at least 1 ADA sample collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of ADA | 1 Participants |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of NAb | 1 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of ADA | 0 Participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of NAb | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of ADA | 0 Participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of NAb | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of ADA | 0 Participants |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of NAb | 0 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of ADA | 10 Participants |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of NAb | 9 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of ADA | 0 Participants |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Number of Participants With Anti-Drug Antibodies (ADA) and Neutralizing Antibody (NAb) of PF-06647020 - Q3W Regimen | Overall incidence of NAb | 0 Participants |
Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Time frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen | NA Ratio | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen | NA Ratio | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen | 1.046 Ratio | Geometric Coefficient of Variation 61 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen | 1.094 Ratio | Geometric Coefficient of Variation 39 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Observed Accumulation Ratio (Rac) for PF-06647020 - Q3W Regimen | NA Ratio | — |
Percentage of Participants With Objective Response - Q2W Regimen
Percentage of participants with objective response based on assessment of CR or PR according to RECIST version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Population: Participants enrolled in Q2W with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Percentage of Participants With Objective Response - Q2W Regimen | 33.3 Percentage of participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Percentage of Participants With Objective Response - Q2W Regimen | 26.3 Percentage of participants |
Percentage of Participants With Objective Response - Q3W Regimen
Percentage of participants with objective response based on assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Population: Participants enrolled in Q3W regimen with measurable disease (non-small cell lung cancer \[NSCLC\], ovarian cancer \[OVCA\], triple negative breast cancer \[TNBC\]) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Percentage of Participants With Objective Response - Q3W Regimen | 16.0 Percentage of participants |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Percentage of Participants With Objective Response - Q3W Regimen | 27.3 Percentage of participants |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Percentage of Participants With Objective Response - Q3W Regimen | 20.7 Percentage of participants |
Progression Free Survival - Q2W Regimen
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Progression Free Survival - Q2W Regimen | 2.7 month |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Progression Free Survival - Q2W Regimen | 3.8 month |
Progression Free Survival - Q3W Regimen
Progression free survival (PFS) was the time from randomization date to date of first documentation of PD or death due to any cause. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Progression Free Survival - Q3W Regimen | 2.9 month |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Progression Free Survival - Q3W Regimen | 2.9 month |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Progression Free Survival - Q3W Regimen | 1.5 month |
Rac for hu6M024 mAb - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Time frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Rac for hu6M024 mAb - Q2W Regimen | NA Ratio | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Rac for hu6M024 mAb - Q2W Regimen | 1.280 Ratio | Geometric Coefficient of Variation 32 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Rac for hu6M024 mAb - Q2W Regimen | 1.301 Ratio | Geometric Coefficient of Variation 35 |
Rac for hu6M024 mAb - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Time frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Rac for hu6M024 mAb - Q3W Regimen | NA Ratio | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Rac for hu6M024 mAb - Q3W Regimen | NA Ratio | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Rac for hu6M024 mAb - Q3W Regimen | 1.022 Ratio | Geometric Coefficient of Variation 108 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Rac for hu6M024 mAb - Q3W Regimen | 0.9865 Ratio | Geometric Coefficient of Variation 48 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Rac for hu6M024 mAb - Q3W Regimen | NA Ratio | — |
Rac for PF-06380101 - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Time frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Rac for PF-06380101 - Q2W Regimen | NA Ratio | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Rac for PF-06380101 - Q2W Regimen | 0.9980 Ratio | Geometric Coefficient of Variation 26 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Rac for PF-06380101 - Q2W Regimen | 0.9657 Ratio | Geometric Coefficient of Variation 25 |
Rac for PF-06380101 - Q3W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 504 hours for the Q3W dosing). Rac=Cycle 4 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Time frame: pre-dose, 1, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Rac for PF-06380101 - Q3W Regimen | NA Ratio | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Rac for PF-06380101 - Q3W Regimen | NA Ratio | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Rac for PF-06380101 - Q3W Regimen | 0.5454 Ratio | Geometric Coefficient of Variation 40 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Rac for PF-06380101 - Q3W Regimen | 0.8916 Ratio | Geometric Coefficient of Variation 41 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Rac for PF-06380101 - Q3W Regimen | NA Ratio | — |
Rac for PF-06647020 - Q2W Regimen
Rac is defined as observed accumulation ratio based on dose normalized AUCtau (AUCtau\[dn\]), where AUCtau is the area under the concentration-time profile from time 0 to time tau (tau equals to 336 hours for the Q2W dosing). Rac= Cycle 3 Day 1 AUCtau(dn) (multiple dose) /Cycle 1 Day 1 AUCtau(dn) (single Dose).
Time frame: pre-dose, end of infusion, 4 hours post-dose on Day 1 of Cycle 1 and Day 1 of Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Rac for PF-06647020 - Q2W Regimen | NA Ratio | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Rac for PF-06647020 - Q2W Regimen | 1.425 Ratio | Geometric Coefficient of Variation 35 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Rac for PF-06647020 - Q2W Regimen | 1.211 Ratio | Geometric Coefficient of Variation 18 |
t1/2 for hu6M024 mAb - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | NA day | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 3.436 day | Standard Deviation 0.75 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 4.734 day | Standard Deviation 0.67 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 3.645 day | Standard Deviation 0.752 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 4.124 day | Standard Deviation 1.218 |
t1/2 for hu6M024 mAb - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 5.087 day | Standard Deviation 2.626 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 4.505 day | Standard Deviation 0.65 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 3.674 day | Standard Deviation 1.512 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 5.232 day | Standard Deviation 2.259 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | t1/2 for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 4.386 day | Standard Deviation 0.895 |
t1/2 for PF-06380101 - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 2.507 day | Standard Deviation 0.411 |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | NA day | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 2.646 day | Standard Deviation 0.453 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 2.755 day | Standard Deviation 0.653 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 2.592 day | Standard Deviation 0.331 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 3.007 day | Standard Deviation 0.373 |
t1/2 for PF-06380101 - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 3.150 day | Standard Deviation 0.426 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 2.827 day | Standard Deviation 0.391 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 2.881 day | Standard Deviation 0.604 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 2.781 day | Standard Deviation 0.676 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | t1/2 for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 3.210 day | Standard Deviation 0.473 |
t1/2 for PF-06647020 - Q2W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | t1/2 for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | NA day | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 2.700 day | Standard Deviation 0.625 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | t1/2 for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 3.633 day | Standard Deviation 0.415 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 2.874 day | Standard Deviation 0.385 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | t1/2 for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 3.600 day | Standard Deviation 0.583 |
Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen
Terminal half-life (t1/2) is the time measured for the plasma concentration of drug to decrease by one half.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA day | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 4.013 day | Standard Deviation 2.891 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 3.600 day | Standard Deviation 0.487 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 3.107 day | Standard Deviation 1.161 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 4.007 day | Standard Deviation 1.496 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA day | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Terminal Half-Life (t1/2) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 3.514 day | Standard Deviation 0.696 |
Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 2.48 hour |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 3.05 hour |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 1.08 hour |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 1.65 hour |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Time for Cmax (Tmax) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 2.49 hour |
Time to Progression - Q2W Regimen
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Time frame: Baseline, every 8 weeks from the start of study treatment until disease progression, death or withdrawal from treatment (approximately 19 months).
Population: Participants enrolled in Q2W regimen with measurable disease (NSCLC, OVCA) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Time to Progression - Q2W Regimen | 2.7 month |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Time to Progression - Q2W Regimen | 3.8 month |
Time to Progression - Q3W Regimen
Time to progression (TTP) was the time from start date to the date of the first documentation of PD. PD was defined as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of one or more new lesions.
Time frame: Baseline, every 6 weeks from the start of treatment until disease progression, death or withdrawal from treatment (approximately 32 months).
Population: Participants enrolled in Q3W regimen with measurable disease (NSCLC, OVCA, TNBC) who had received at least 1 dose of study medication and had a baseline tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Time to Progression - Q3W Regimen | 2.9 month |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Time to Progression - Q3W Regimen | 3.1 month |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Time to Progression - Q3W Regimen | 2.2 month |
Tmax for hu6M024 mAb - Q2W Regimen
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 3.98 hour |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | NA hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 1.05 hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 3.87 hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q2W Regimen | Cycle 1, Single Dose | 1.05 hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q2W Regimen | Cycle 3, Multiple Dose | 2.36 hour |
Tmax for hu6M024 mAb - Q3W Regimen
Tmax is the time for Cmax. Tmax for hu6M024 mAb was observed directly from data as time of first occurrence.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 4.00 hour |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 3.05 hour |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 3.70 hour |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | 3.90 hour |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Tmax for hu6M024 mAb - Q3W Regimen | Cycle 1, Single Dose | 2.31 hour |
Tmax for PF-06380101 - Q2W Regimen
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 3.98 hour |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | NA hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 4.05 hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 71.7 hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q2W Regimen | Cycle 1, Single Dose | 24.7 hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q2W Regimen | Cycle 3, Multiple Dose | 22.8 hour |
Tmax for PF-06380101 - Q3W Regimen
Tmax is the time for Cmax. Tmax for PF-06380101 was observed directly from data as time of first occurrence.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | NA hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 23.8 hour |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 23.6 hour |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 23.9 hour |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | 21.9 hour |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 4, Multiple Dose | NA hour |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Tmax for PF-06380101 - Q3W Regimen | Cycle 1, Single Dose | 23.4 hour |
Tmax for PF-06647020 - Q2W Regimen
Tmax is the time for Cmax. Tmax for PF-06647020 was observed directly from data as time of first occurrence.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 3.98 hour |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Tmax for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | NA hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 2.45 hour |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Tmax for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 1.07 hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 1.05 hour |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Tmax for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 2.36 hour |
Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: pre-dose, 1, 4, 24, 72, 168, 336 hours post-dose for Cycle 1 and Cycle 4 (21 days cycle).
Population: All participants enrolled in Q3W regimen (except DDI sub-study) who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA Liter (L) | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA Liter (L) | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA Liter (L) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | NA Liter (L) | — |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA Liter (L) | — |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 3.498 Liter (L) | Geometric Coefficient of Variation 26 |
| PF-06647020 2.1 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 3.230 Liter (L) | Geometric Coefficient of Variation 46 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 3.199 Liter (L) | Geometric Coefficient of Variation 40 |
| PF-06647020 2.8 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | 2.808 Liter (L) | Geometric Coefficient of Variation 47 |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 4, Multiple Dose | NA Liter (L) | — |
| PF-06647020 3.7 mg/kg (Q3W Regimen) | Volume of Distribution at Steady State (Vss) for PF-06647020 - Q3W Regimen | Cycle 1, Single Dose | 3.947 Liter (L) | Geometric Coefficient of Variation 52 |
Vss for PF-06647020 - Q2W Regimen
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time frame: pre-dose, end of infusion, 4, 24, 72, 168 hours post-dose, Day 15 (pre-dose, end of infusion) for Cycle 1 and Cycle 3 (28 days cycle).
Population: All participants enrolled in Q2W regimen who received at least 1 dose of study treatment and had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Vss for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | NA Liter | — |
| PF-06647020 0.2 mg/kg(Q3W Regimen) | Vss for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | NA Liter | — |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Vss for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 2.566 Liter | Geometric Coefficient of Variation 44 |
| PF-06647020 0.5 mg/kg (Q3W Regimen) | Vss for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 2.349 Liter | Geometric Coefficient of Variation 24 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Vss for PF-06647020 - Q2W Regimen | Cycle 1, Single Dose | 2.953 Liter | Geometric Coefficient of Variation 36 |
| PF-06647020 1.25 mg/kg (Q3W Regimen) | Vss for PF-06647020 - Q2W Regimen | Cycle 3, Multiple Dose | 3.106 Liter | Geometric Coefficient of Variation 32 |