| Primary | Number of Participants With Dose Limiting Toxicities (DLT) | DLTs was defined as any of the following adverse events (AEs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at first 2 Cycles. Hematologic: (1) Grade 4 neutropenia lasting >7 days; (2) Febrile neutropenia, defined as absolute neutrophil count (ANC) <1000/mm3 with a single temperature of >38.3 degrees C (101 degrees F) or a sustained temperature of >=38 degrees C (100.4 degrees F) for more than 1 hour; (3) Grade >=3 neutropenic infection; (4) Grade >=3 thrombocytopenia with bleeding; (5) Grade 4 thrombocytopenia. Non-Hematologic: (1) Grade >=3 non laboratory toxicities (excluding infusion reactions), except those that had not been maximally treated (eg, nausea, vomiting, diarrhea); (2) Grade >=3 laboratory abnormalities (other than aspartate aminotransferase [AST]/alanine aminotransferase [ALT]) if: Medical intervention was required to treat the participant, or The abnormality led to hospitalization; (3) Grade 4 AST and ALT increase. | All enrolled participants who were eligible for the study and received study treatment. | Posted | | Count of Participants | | Participants | | First 2 Cycles (28 days in each cycle) | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG003 | PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 5 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | An AE was any untoward medical occurrence in a participant administered a product or medical device without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs. | All enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Day 1 up to 60 days after last dose of study treatment | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with PF-05082566. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs. | All enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Day 1 up to 60 days after last dose of study treatment | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 |
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| Secondary | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | An AE was any untoward medical occurrence in a participant administered a product or medical device has a causal relationship with Mogamulizumab. SAEs were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions); resulted in congenital anomaly/birth defect. Treatment-emergent AEs were those with initial onset or increasing in severity after the first dose of study treatment. AEs were graded by the investigator according to NCI CTCAE version 4.03 (Grade 1: mild AE; Grade 2: moderate AE; Grade 3: severe AE; Grade 4: life-threatening consequences, urgent intervention indicated; Grade 5: death related to AE). AEs included non-serious AEs and SAEs. | All enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Day 1 up tp 60 days after last dose of study treatment | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 |
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| Secondary | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells. | All enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | The chemistry laboratory tests included: Alanine aminotransferase, Aspartate Aminotransferase, Alkaline Phosphatase, Lactate Dehydrogenase, Sodium, Potassium, Magnesium, Total Calcium, Phosphorus or Phosphate, Total bilirubin, Creatinine or creatinine clearance, Albumin, Total proteins, Uric Acid, BUN or Urea, Immunoglobulin G, Glucose (fasted). | All enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Number of Participants With Clinical Significant Observations in Vital Signs | Blood pressure (BP) and pulse rate were recorded in supine or sitting position. | All enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Number of Participants With Significant Changes From Baseline in Physical Examination | Physical examination included an examination of major body systems, including general, head, ears, eyes, nose, mouth, throat, neck, lungs, heart, abdomen, musculoskeletal, lymph nodes, neurological and external genitalia. Significant changes from baseline were reported in each category. | All enrolled participants who received at least 1 dose of study treatment. Number analyzed was the number of participants at the given category. | Posted | | Count of Participants | | Participants | | Cycle 2 Day 1; End of the treatment. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 |
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| Secondary | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5 | ECOG performance status was classified as 5 grades: 0 (Fully active, able to carry on all predisease performance without restriction); 1 (Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, ie, light house work, office work); 2 (Ambulatory and capable of all self care but unable to carry out any work activities. Up and about more than 50% of waking hours); 3 (Capable of only limited self care, confined to bed or chair more than 50% of waking hours); 4 (Completely disabled. Cannot carry on any self care. Totally confined to bed or chair); 5 (Death). On-study shifts to ECOG performance statuses of 2, 3, 4 or 5 were reported. | All enrolled participants who received at least 1 dose of study treatment. | Posted | | Count of Participants | | Participants | | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | |
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| Secondary | Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5 | Maximum Observed Serum Concentration (Cmax) was observed directly from the data. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Dose Normalized Cmax of PF-05082566-Cycle 5 | Dose normalized Cmax was calculated by Cmax / Dose | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg/mL/mg/kg | | Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Cmax of Mogamulizumab-Cycles 1 and 5 | Maximum Observed Serum Concentration (Cmax) was observed directly from the data. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15 | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 |
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| Secondary | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5 | Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Ctrough of Mogamulizumab- Cycle 5 | Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg/mL | | Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15 | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Time for Cmax (Tmax) of PF-05082566-Cycle 5 | Time for Cmax (Tmax) was observed directly from the data. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hour | | Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | |
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| Secondary | Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5 | Time of last measurable concentration was observed directly from data. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hour | | Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Tmax of Mogamulizumab-Cycles 1 and 5 | Time for Cmax (Tmax) was observed directly from the data. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hour | | Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15 | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Tlast of Mogamulizumab-Cycles 1 and 5 | Time of last measurable concentration was observed directly from the data. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Median | Full Range | hour | | Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15 | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5 | AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg*hr/mL | | Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Dose Normalized AUClast of PF-05082566-Cycle 5 | Dose normalized AUClast was calculated by AUClast / Dose | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | µg•hr/mL/mg/kg | | Cycle 5: Day 1 at pre-dose, at the end of PF-05082566 infusion, and at 2, 6, 168 hours (Day 8) and 336 hours (Day 15) after the start of PF-05082566 infusion. | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | AUClast of Mogamulizumab-Cycles 1 and 5 | AUClast was area under the serum concentration-time profile from time 0 to the time of the last measurable concentration (Clast), which was measured by Linear/Log trapezoidal method. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg*hr/mL | | Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22; Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15 | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1 | AUC168 was area under the serum concentration-time profile from time 0 to 168 hours post dose (Cycle 1 only where dosing was once a week), which was measured by Linear/Log trapezoidal method. | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg*hr/mL | | Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22 | | | | ID | Title | Description |
|---|
| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | |
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| Secondary | Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5 | AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | μg*hr/mL | | Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | |
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| Secondary | Clearance (CL) of Mogamulizumab-Cycle 5 | Clearance (CL) was measured by Dose / AUCtau | The PK parameter analysis population was defined as all enrolled participants who had been treated and whose concentration time data allowed the estimation of at least 1 of the PK parameters of interest. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mL/hr/kg | | Cycle 5: Pre-dose, at the end of mogamulizumab infusion, and at 6 hours, 168 hours (Day 8) after the start of the mogamulizumab infusion; Pre-dose on Day 15 | | | | ID | Title | Description |
|---|
| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg |
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| Secondary | Anti-Drug Antibody (ADA) Titer for PF-05082566 | Serum samples were assayed for ADA using a validated analytical method. | Number of participants analyzed was determined as participants with treatment-induced ADA. | Posted | | Median | Inter-Quartile Range | Titer | | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Neutralizing Antibodies (NAb) Titers for PF-05082566 | ADA positive samples were further analyzed for NAb using a validated assay. | Number of participants analyzed was determined as participants with treatment-induced NAb. | Posted | | Median | Inter-Quartile Range | Titer | | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Anti-Drug Antibody (ADA) Titers for Mogamulizumab | Serum samples were assayed for ADA using a validated analytical method. | Number of participants analyzed was determined as participants with treatment-induced ADA. | Posted | | Median | Inter-Quartile Range | Titer | | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Neutralizing Antibodies (NAb) Titers for Mogamulizumab | ADA positive samples were further analyzed for NAb using a validated assay | Number of participants analyzed was determined as participants with treatment-induced NAb. | Posted | | | | | | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG002 | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 2.4 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | OR was defined as best overall response (BOR) of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumor (RECIST) version 1.1. Immune-related OR (irOR) was defined as immune-related BOR (irBOR) of immune-related CR (irCR) and immune-related PR (irPR) according to immune-related RECIST. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. | The full analysis set included all enrolled participants. | Posted | | Count of Participants | | Participants | | Every 8 weeks up to 24 months | | | | ID | Title | Description |
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| OG000 | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 1.2 mg/kg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. | | OG001 | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 was administered as a 1-hour intravenous infusion every 4 weeks on Day 1 of each cycle at 100 mg. Mogamulizumab was administered as a 1-hour intravenous infusion weekly for 4 consecutive weeks (Days 1, 8, 15 and 22) followed by biweekly dosing (Days 1 and 15) at 1 mg/kg. |
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| Secondary | Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion | TTR was defined, for participants with an OR, as the time from the date of first dose of study treatment to the first documentation of OR (CR or PR), which was subsequently confirmed. irTTR was defined, for participants with an irOR, as the time from the first dose of study treatment to the first documentation of irOR (irCR or irPR) which was subsequently confirmed. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. | No participants were enrolled in the dose-expansion portion. | Posted | | | | | | Every 8 weeks up to 24 months | | | | ID | Title | Description |
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| OG000 | Dose Expansion Cohort | Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers. |
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| Secondary | Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion | DR was defined, for participants with an OR, as the time from first documentation of OR (CR or PR) to the date of first documentation of objective progression disease (PD) or death due to any cause. irDR was defined, for participants with an irOR, as the time from the first documentation of irOR (irCR or irPR) to the date of first documentation of immune-related PD (irPD) (which was subsequently confirmed) or death due to any cause. CR: Complete disappearance of all target lesions with the exception of nodal disease; PR: Greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions; PD: 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. | No participants were enrolled in the dose-expansion portion. | Posted | | | | | | Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months | | | | ID | Title | Description |
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| OG000 | Dose Expansion Cohort | Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers. |
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| Secondary | Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion | PFS was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. irPFS was defined as the time from the first dose of study treatment to the date of first documentation of irPD (which was subsequently confirmed) or death due to any cause, whichever occurred first. PD:20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. | No participants were enrolled in the dose-expansion portion. | Posted | | | | | | Every 8 weeks up to 24 months | | | | ID | Title | Description |
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| OG000 | Dose Expansion Cohort | Expansion cohorts of participants were to be enrolled to further study the safety, tolerability, PK/PD, and preliminary anti tumor activity for PF-05082566 in combination with mogamulizumab, as well as to study tumor associated biomarkers. |
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