Breast Neoplasms, Carcinoma, Non Small Cell Lung, Neoplasms, Ovarian Neoplasms
Conditions
Keywords
ADC 5T4, PF-06263507, solid tumors, lung cancer, breast cancer, ovarian cancer, cancer, tumors, neoplasm metastasis
Brief summary
To assess the safety and tolerability at increasing dose levels of PF-06263507 in patients with advanced solid tumors in order to determine the maximum tolerated dose and select the recommended Phase 2 dose.
Interventions
DRUGPF-06263507
Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.
Sponsors
Pfizer
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of solid tumor that is advanced/metastatic and resistant to standard therapy or for which no standard therapy is available. * Performance Status of 0 or 1. * Adequate bone marrow, kidney, liver, and heart function.
Exclusion criteria
* Brain metastases requiring steroids. * Major surgery or anti-cancer therapy within 4 weeks of study treatment start. * Active bacterial, fungal or viral infection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose-limiting Toxicities (DLT) | Baseline up to Cycle 2 Day 1 (22 days) | DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting \>7 days, 2) Febrile neutropenia, 3) Grade \>=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade \>=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up. | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported. |
| Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up. | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported. |
| Number of Participants With Hematological Test Abnormalities in All Cycles. | Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment | Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities. |
| Number of Participants With Chemistry Test Abnormalities in All Cycles. | Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment | Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities. |
| Number of Participants With Abnormalities in Urine Protein in All Cycles. | Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment | Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein. |
| Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up. | Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of \<90 millimeters of mercury (mm Hg) or change in sitting SBP of \>=30 mm Hg, sitting diastolic blood pressure (DBP) of \<50 mm Hg or change in sitting DBP of \>=20 mm Hg, sitting pulse rate of \<40 or \>120 beats per minute (bpm). |
| Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose. | — |
| Number of Participants With Best Overall Response (BOR) | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months. | Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)\>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \>=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start. |
| Objective Response | Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months. | Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met. |
| Overall Survival | Baseline to death | Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population. |
| Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose. | — |
| Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose. | — |
| Number of Participants With Positive Anti-PF-06263507 Antibody | Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication | The number of participants with positive anti-PF-06263507 antibody. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-06263507 0.05 mg/kg PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 2 |
| PF-06263507 0.1 mg/kg PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 2 |
| PF-06263507 0.19 mg/kg PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 2 |
| PF-06263507 0.37 mg/kg PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 2 |
| PF-06263507 0.73 mg/kg PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 2 |
| PF-06263507 1.42 mg/kg PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 2 |
| PF-06263507 2.78 mg/kg PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 2 |
| PF-06263507 4.34 mg/kg PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 6 |
| PF-06263507 5.42 mg/kg PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 3 |
| PF-06263507 6.5 mg/kg PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose. | 3 |
| Total | 26 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
| Overall Study | Other | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 2 | 1 | 1 |
Baseline characteristics
| Characteristic | PF-06263507 0.05 mg/kg | PF-06263507 0.1 mg/kg | PF-06263507 0.19 mg/kg | PF-06263507 0.37 mg/kg | PF-06263507 0.73 mg/kg | PF-06263507 1.42 mg/kg | PF-06263507 2.78 mg/kg | PF-06263507 4.34 mg/kg | PF-06263507 5.42 mg/kg | PF-06263507 6.5 mg/kg | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 2.1 | 57 years STANDARD_DEVIATION 4.2 | 41 years STANDARD_DEVIATION 22.6 | 60 years STANDARD_DEVIATION 7.1 | 53.5 years STANDARD_DEVIATION 14.8 | 62 years STANDARD_DEVIATION 36.8 | 61.5 years STANDARD_DEVIATION 7.8 | 65.2 years STANDARD_DEVIATION 9.9 | 57.7 years STANDARD_DEVIATION 5.1 | 67.7 years STANDARD_DEVIATION 5.9 | 59.9 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male FEMALE | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 2 Participants | 4 Participants | 2 Participants | 1 Participants | 15 Participants |
| Sex: Female, Male MALE | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 2 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 2 / 2 | 6 / 6 | 3 / 3 | 3 / 3 |
| serious Total, serious adverse events | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 0 / 2 | 1 / 6 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Number of Participants With Dose-limiting Toxicities (DLT)
DLT was defined as any of the following adverse events (AEs) occurring in the first cycle of treatment (21 days) which were attributable to PF-06263507: 1) Grade 4 neutropenia lasting \>7 days, 2) Febrile neutropenia, 3) Grade \>=3 neutropenia with infection, 4) Any grade thrombocytopenia associated with clinically significant or life-threatening bleeding, 4) Grade 4 thrombocytopenia, 5) Any grade \>=3 non-hematologic toxicities, 6) A positive cardiac troponin I result, 7) Persisting non-hematologic toxicities resulted in more than 2 weeks delay in receiving the next scheduled cycle. Severity of AEs was graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time frame: Baseline up to Cycle 2 Day 1 (22 days)
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Dose-limiting Toxicities (DLT) | 2 Participants |
Secondary
Number of Participants With Abnormalities in Urine Protein in All Cycles.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 abnormalities in urine protein.
Time frame: Baseline, Day 15 for Cycle 1, Day 1 for Cycle 2 and subsequent cycles, and end of treatment
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Abnormalities in Urine Protein in All Cycles. | Urine protein Grade 2 | 1 Participants |
Secondary
Number of Participants With Best Overall Response (BOR)
Number of participants with best overall response. Complete response (CR)=disappearance of all target lesions. Partial Response (PR)\>=30% decrease in sum of longest dimensions of lesions taking as reference baseline sum longest dimensions. Progressive disease (PD) \>=20% increase in sum of longest dimensions of lesions taking as a reference smallest sum of the longest dimensions since treatment start, or the appearance of \>=1 new lesion. Stable disease (SD)=neither shrinkage for PR or increase for PD taking as reference smallest sum of longest dimensions since treatment start.
Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Population: Participants who had received at least one dose of study medication and had a baseline tumor assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 0.05 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 1 pariticpants |
| PF-06263507 0.05 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
| PF-06263507 0.05 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 0.05 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 0.05 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 0.05 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 1 pariticpants |
| PF-06263507 0.1 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 0.1 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
| PF-06263507 0.1 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 0.1 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 0.1 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 0.1 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 0.1 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 2 pariticpants |
| PF-06263507 0.19 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 0.19 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 1 pariticpants |
| PF-06263507 0.19 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 0.19 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 0.19 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 0.19 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 1 pariticpants |
| PF-06263507 0.19 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 0.37 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 0.37 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 1 pariticpants |
| PF-06263507 0.37 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 0.37 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 0.37 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 0.37 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 1 pariticpants |
| PF-06263507 0.37 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 0.73 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 2 pariticpants |
| PF-06263507 0.73 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 0.73 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 0.73 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 0.73 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
| PF-06263507 0.73 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 0.73 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 2 pariticpants |
| PF-06263507 1.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 2 pariticpants |
| PF-06263507 2.78 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 4.34 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 4.34 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 4.34 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 4.34 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 4 pariticpants |
| PF-06263507 4.34 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 2 pariticpants |
| PF-06263507 4.34 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
| PF-06263507 4.34 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 3 pariticpants |
| PF-06263507 5.42 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 6.5 mg/kg | Number of Participants With Best Overall Response (BOR) | PR | 0 pariticpants |
| PF-06263507 6.5 mg/kg | Number of Participants With Best Overall Response (BOR) | Interminate | 1 pariticpants |
| PF-06263507 6.5 mg/kg | Number of Participants With Best Overall Response (BOR) | Objective progression | 1 pariticpants |
| PF-06263507 6.5 mg/kg | Number of Participants With Best Overall Response (BOR) | Early death | 0 pariticpants |
| PF-06263507 6.5 mg/kg | Number of Participants With Best Overall Response (BOR) | CR | 0 pariticpants |
| PF-06263507 6.5 mg/kg | Number of Participants With Best Overall Response (BOR) | Stable/No response | 1 pariticpants |
| PF-06263507 6.5 mg/kg | Number of Participants With Best Overall Response (BOR) | Symptomatic deterioration | 0 pariticpants |
Secondary
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Criteria for potentially clinically important (PCI) change in vital signs included: sitting systolic blood pressure (SBP) of \<90 millimeters of mercury (mm Hg) or change in sitting SBP of \>=30 mm Hg, sitting diastolic blood pressure (DBP) of \<50 mm Hg or change in sitting DBP of \>=20 mm Hg, sitting pulse rate of \<40 or \>120 beats per minute (bpm).
Time frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, end of treatment, and follow-up.
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 2 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 1 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 1 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 2 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 2 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 2 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 3 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum decrease from baseline >=30 mm Hg | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP <50 mm Hg | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum decrease from baseline >=20 mm Hg | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | SBP maximum increase from baseline >=30 mm Hg | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria | DBP maximum increase from baseline >=20 mm Hg | 1 Participants |
Secondary
Number of Participants With Chemistry Test Abnormalities in All Cycles.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 chemistry tests abnormalities.
Time frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 2 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 2 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 2 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 2 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 2 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 2 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 2 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 2 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 2 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 2 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 2 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 1 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 2 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 2 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 1 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 1 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 1 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 2 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 2 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 2 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 2 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 2 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 2 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 3 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 4 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 6 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 5 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 2 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 2 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 3 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 5 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 2 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 3 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 3 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 2 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 2 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 3 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 2 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoalbuminemia Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 3 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypernatremia Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperkalemia Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 2 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alanine aminotransferase (ALT) Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypomagnesemia Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyperglycemia Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 4 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypercalcemia Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Creatinine Grade 2 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 1 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 2 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Bilirubin (total) Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade3 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hyponatremia Grade 3 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 3 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | AST Grade 2 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Aspartate aminotransferase (AST) Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 3 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypophosphatemia Grade 2 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 2 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypoglycemia Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Alkaline phosphatase Grade 1 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypokalemia Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Chemistry Test Abnormalities in All Cycles. | Hypocalcemia Grade 2 | 1 Participants |
Secondary
Number of Participants With Hematological Test Abnormalities in All Cycles.
Number of participants with NCI CTCAE (version 4.0) grade 1 to 4 hematological test abnormalities.
Time frame: Baseline, Days 1, 3, 8 and 15 for Cycle 1, Days 1, 8, 15 for Cycle 2 and subsequent cycles, and end of treatment
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 0 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 1 Participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 0 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 1 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 2 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 2 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 2 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 1 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 2 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 3 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 1 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 3 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 4 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 2 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 2 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 1 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 2 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Platelets Grade 3 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | White blood cells (WBC) Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 1 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 4 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 2 | 1 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Anemia Grade 1 | 2 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Hemoglobin increased Grade 1 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 3 | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Hematological Test Abnormalities in All Cycles. | Lymphopenia Grade 2 | 0 Participants |
Secondary
Number of Participants With Positive Anti-PF-06263507 Antibody
The number of participants with positive anti-PF-06263507 antibody.
Time frame: Pre-dose Day 1, Cycle 1 Day 15, Day 1 of every Cycle, up to 21 days after the last dose of study medication
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 1 Participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 0 Participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 1 Participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 1 Participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 0 Participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 0 Participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 0 Participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 0 Participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 0 Participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Positive Anti-PF-06263507 Antibody | 1 Participants |
Secondary
Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Time frame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 2 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 2 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 1 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 1 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 3 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 6 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 3 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Total | 3 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-emergent Adverse Events (TEAEs), by Maximum National Cancer Institute (NCI) Common Terminology Criteria (CTC) for AEs (CTCAE) (Version 4.0) Grade | Any AEs, Grade 3 | 2 participants |
Secondary
Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs are events which occurred between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. If the same participant in a given treatment had more than 1 occurrence in the same preferred term event category, only the worst CTCAE grade was reported.
Time frame: Baseline, Day 1 to 15 for Cycle 1, Day 1 to end of treatment for Cycle 2 and subsequent cycles, and follow-up.
Population: All enrolled participants who received at least one dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 1 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 0.05 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 1 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 0.1 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 1 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.19 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 2 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.37 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 1 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 0.73 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 2 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 1.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 0 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 2 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 0 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 2 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 2.78 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 4 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 6 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 4.34 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 1 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 1 participants |
| PF-06263507 5.42 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 3 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 2 | 2 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 1 | 0 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 3 | 1 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 4 | 0 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Total | 3 participants |
| PF-06263507 6.5 mg/kg | Number of Participants With Treatment-related AEs, by Maximum NCI CTCAE (Version 4.0) Grade | Any AEs, Grade 5 | 0 participants |
Secondary
Objective Response
Number of particpants with objective response: confirmed CR or confirmed PR according to RECIST. CR was defined as the disappearance of all target lesions. A PR was defined as a ≥30% decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions. To be assigned a status of PR or CR, changes in tumor measurements in participants with responding tumors had to have been confirmed by repeat studies that were performed ≥ 4 weeks after the criteria for response were first met.
Time frame: Baseline, every 6 weeks until disease progression or unacceptable toxicity up to 24 months.
Population: Participants who had received at least one dose of study medication and had a baseline tumor assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PF-06263507 0.05 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 0.1 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 0.19 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 0.37 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 0.73 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 4.34 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Objective Response | 0 pariticpants |
| PF-06263507 6.5 mg/kg | Objective Response | 0 pariticpants |
Secondary
Overall Survival
Overall survival was defined as the time from initial dose until death from any cause, and was measured in the intent-to-treat population.
Time frame: Baseline to death
Population: All enrolled participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PF-06263507 0.05 mg/kg | Overall Survival | Number of deaths | 0 pariticpants |
| PF-06263507 0.05 mg/kg | Overall Survival | Number for censored | 2 pariticpants |
| PF-06263507 0.1 mg/kg | Overall Survival | Number of deaths | 1 pariticpants |
| PF-06263507 0.1 mg/kg | Overall Survival | Number for censored | 1 pariticpants |
| PF-06263507 0.19 mg/kg | Overall Survival | Number of deaths | 0 pariticpants |
| PF-06263507 0.19 mg/kg | Overall Survival | Number for censored | 2 pariticpants |
| PF-06263507 0.37 mg/kg | Overall Survival | Number of deaths | 0 pariticpants |
| PF-06263507 0.37 mg/kg | Overall Survival | Number for censored | 2 pariticpants |
| PF-06263507 0.73 mg/kg | Overall Survival | Number for censored | 2 pariticpants |
| PF-06263507 0.73 mg/kg | Overall Survival | Number of deaths | 0 pariticpants |
| PF-06263507 1.42 mg/kg | Overall Survival | Number for censored | 2 pariticpants |
| PF-06263507 1.42 mg/kg | Overall Survival | Number of deaths | 0 pariticpants |
| PF-06263507 2.78 mg/kg | Overall Survival | Number for censored | 2 pariticpants |
| PF-06263507 2.78 mg/kg | Overall Survival | Number of deaths | 0 pariticpants |
| PF-06263507 4.34 mg/kg | Overall Survival | Number of deaths | 1 pariticpants |
| PF-06263507 4.34 mg/kg | Overall Survival | Number for censored | 5 pariticpants |
| PF-06263507 5.42 mg/kg | Overall Survival | Number of deaths | 0 pariticpants |
| PF-06263507 5.42 mg/kg | Overall Survival | Number for censored | 3 pariticpants |
| PF-06263507 6.5 mg/kg | Overall Survival | Number of deaths | 1 pariticpants |
| PF-06263507 6.5 mg/kg | Overall Survival | Number for censored | 2 pariticpants |
Secondary
Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax)
Time frame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06263507 0.05 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.07 hour |
| PF-06263507 0.1 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.00 hour |
| PF-06263507 0.19 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 2.49 hour |
| PF-06263507 0.37 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.01 hour |
| PF-06263507 0.73 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.03 hour |
| PF-06263507 1.42 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.02 hour |
| PF-06263507 2.78 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 2.49 hour |
| PF-06263507 4.34 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.13 hour |
| PF-06263507 5.42 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.03 hour |
| PF-06263507 6.5 mg/kg | Time to Reach Maximum Observed Serum PF-06263507 Concentration (Tmax) | 1.22 hour |
Secondary
Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax)
Time frame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06263507 0.05 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 36.2 hour |
| PF-06263507 0.1 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 16.0 hour |
| PF-06263507 0.19 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 37.2 hour |
| PF-06263507 0.37 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 51.0 hour |
| PF-06263507 0.73 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 9.99 hour |
| PF-06263507 1.42 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 9.51 hour |
| PF-06263507 2.78 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 8.02 hour |
| PF-06263507 4.34 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 8.13 hour |
| PF-06263507 5.42 mg/kg | Time to Reach Maximum Observed Serum PF-06264490 Concentration (Tmax) | 8.25 hour |
Secondary
Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax)
Time frame: Baseline,Cycle 1 Day 1 pre-dose,1,4,8,12,24, and 48 hrs post dose,Day 5,Day 8 and Day 15;Day 1 of Cycle 2 and 3,Day 1 of Cycle 4 pre-dose,1,8,12,24 hr post dose, Day 8 and Day 15,every cycle thereafter on day 1 pre-dose, and up to 21 days after last dose.
Population: All enrolled participants treated who had sufficient information to estimate at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-06263507 0.05 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 1.07 hour |
| PF-06263507 0.1 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 4.00 hour |
| PF-06263507 0.19 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 2.53 hour |
| PF-06263507 0.37 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 1.01 hour |
| PF-06263507 0.73 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 6.01 hour |
| PF-06263507 1.42 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 1.02 hour |
| PF-06263507 2.78 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 7.44 hour |
| PF-06263507 4.34 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 4.00 hour |
| PF-06263507 5.42 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 8.00 hour |
| PF-06263507 6.5 mg/kg | Time to Reach Maximum Observed Serum PF-06281192 Concentration (Tmax) | 3.90 hour |