Advanced/Metastatic Solid Tumors
Conditions
Brief summary
This study is a Phase 1b, open label, multi center, multi-dose trial designed to estimate the maximum tolerated dose (MTD) and select the recommended dose for phase 2 (RP2D) investigations of PF- 05082566 in combination with KW-0761 (mogamulizumab) in patients with advanced solid tumors. Once the MTD of PF-05082566 administered in combination with KW-0761 is estimated (dose finding), one or more expansion cohorts of patients with selected advanced solid tumors (dose-expansion ) will be enrolled to further characterize the combination in term of safety profile, anti tumor activity, pharmacokinetics, pharmacodynamics and biomarkers modulation.
Interventions
DRUGPF-05082566
Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.
DRUGKW-0761
Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.
Sponsors
Kyowa Kirin Co., Ltd.
Pfizer
Study design
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological or cytological diagnosis of advanced/metastatic solid tumor malignancy. Dose Finding Cohorts: Tumor types will be limited to CRC, SCCHN, squamous NSCLC, bladder, or ovarian carcinomas which have progressed on standard therapy, or for which no standard therapy is available. * Measurable disease by RECIST version 1.1. * For Expansion Cohorts only: patients must have tumor accessible for biopsies (core needle biopsy or excision preferred). * Age 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate bone marrow, renal and liver function. * Serum/urine pregnancy test (for females of childbearing potential) negative at screening and before the patient will receive the study treatment. * Male and female patients of childbearing potential and at risk for pregnancy must agree to use two (2) highly effective methods of contraception throughout the study and for 60 days after the last dose of assigned study treatment.
Exclusion criteria
* Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis. * Therapeutic or experimental monoclonal antibodies in last 60 days prior registration. * Systemic anticancer therapy or major surgery within 28 days prior to registration. In absence of toxicity from prior systemic anticancer therapy, 5 half-lives since completion of prior systemic anticancer therapy is allowed. * Systemic steroids, any other form of immunosuppressive therapy or radiation therapy within 14 days prior to registration. * Live vaccine within 30 days prior to registration. * Severe hypersensitivity reaction to treatment with another monoclonal antibody, known or suspected hypersensitivity to study drugs or any component of their formulation. * History of autoimmune disease or known inflammatory bowel disease. * Uncontrolled hypertension (blood pressure \>150/100 mmHg despite optimal medical therapy) or any of the following within 12 months prior to registration: myocardial infarction, congenital long QT syndrome, torsade de points, arrhythmias, right bundle branch block and left anterior hemiblock uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, ongoing NCICTCAE Grade 2 cardiac dysrhythmias, atrial fibrillation or QTcF interval \>470 msec.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) | First 2 Cycles (28 days in each cycle) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5 | 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. | Time of last measurable concentration was observed directly from data. |
| Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Day 1 up to 60 days after last dose of study treatment | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Day 1 up to 60 days after last dose of study treatment | 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. |
| Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Day 1 up tp 60 days after last dose of study treatment | 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. |
| Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | The hematology laboratory tests include: Anemia, Hemoglobin increased, Lymphocyte count increased, Lymphopenia, Neutrophils (absolute), Platelets, White blood cells. |
| Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | 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). |
| Number of Participants With Clinical Significant Observations in Vital Signs | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | Blood pressure (BP) and pulse rate were recorded in supine or sitting position. |
| Number of Participants With Significant Changes From Baseline in Physical Examination | Cycle 2 Day 1; End of the treatment. | 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. |
| Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5 | Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment | 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. |
| Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5 | 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. | Maximum Observed Serum Concentration (Cmax) was observed directly from the data. |
| Dose Normalized Cmax of PF-05082566-Cycle 5 | 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. | Dose normalized Cmax was calculated by Cmax / Dose |
| Cmax of Mogamulizumab-Cycles 1 and 5 | 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 | Maximum Observed Serum Concentration (Cmax) was observed directly from the data. |
| Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5 | 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. | Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data |
| Ctrough of Mogamulizumab- Cycle 5 | 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 | Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data. |
| Tmax of Mogamulizumab-Cycles 1 and 5 | 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 | Time for Cmax (Tmax) was observed directly from the data. |
| Time for Cmax (Tmax) of PF-05082566-Cycle 5 | 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. | Time for Cmax (Tmax) was observed directly from the data. |
| Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5 | 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. | 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. |
| Dose Normalized AUClast of PF-05082566-Cycle 5 | 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. | Dose normalized AUClast was calculated by AUClast / Dose |
| AUClast of Mogamulizumab-Cycles 1 and 5 | 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 | 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. |
| Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1 | Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22 | 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. |
| Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5 | 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 | AUCtau was area under the serum concentration-time profile from time 0 to time tau, the dosing interval, where tau=336 hours |
| Clearance (CL) of Mogamulizumab-Cycle 5 | 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 | Clearance (CL) was measured by Dose / AUCtau |
| Anti-Drug Antibody (ADA) Titer for PF-05082566 | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | Serum samples were assayed for ADA using a validated analytical method. |
| Neutralizing Antibodies (NAb) Titers for PF-05082566 | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | ADA positive samples were further analyzed for NAb using a validated assay. |
| Anti-Drug Antibody (ADA) Titers for Mogamulizumab | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | Serum samples were assayed for ADA using a validated analytical method. |
| Neutralizing Antibodies (NAb) Titers for Mogamulizumab | Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months | ADA positive samples were further analyzed for NAb using a validated assay |
| Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | Every 8 weeks up to 24 months | 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. |
| Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion | Every 8 weeks up to 24 months | 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. |
| Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion | Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months | 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. |
| Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion | Every 8 weeks up to 24 months | 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. |
| Tlast of Mogamulizumab-Cycles 1 and 5 | 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 | Time of last measurable concentration was observed directly from the data. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 11 |
| 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. | 6 |
| 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. | 4 |
| 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. | 3 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 3 | 0 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 0 | 0 |
| Overall Study | Objective progression or relapse | 9 | 1 | 2 | 3 |
| Overall Study | Other | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 100 mg + Mogamulizumab 1 mg/kg | PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 4.9 | 66.2 years STANDARD_DEVIATION 8.6 | 67.8 years STANDARD_DEVIATION 4 | 62.7 years STANDARD_DEVIATION 8.7 | 63.9 years STANDARD_DEVIATION 6.5 |
| Race/Ethnicity, Customized Black | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 9 Participants | 6 Participants | 3 Participants | 1 Participants | 19 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 5 Participants | 2 Participants | 2 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 3 / 6 | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 11 / 11 | 6 / 6 | 4 / 4 | 3 / 3 |
| serious Total, serious adverse events | 3 / 11 | 3 / 6 | 2 / 4 | 2 / 3 |
Outcome results
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.
Time frame: First 2 Cycles (28 days in each cycle)
Population: All enrolled participants who were eligible for the study and received study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Dose Limiting Toxicities (DLT) | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Dose Limiting Toxicities (DLT) | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Dose Limiting Toxicities (DLT) | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Dose Limiting Toxicities (DLT) | 0 Participants |
Secondary
Anti-Drug Antibody (ADA) Titer for PF-05082566
Serum samples were assayed for ADA using a validated analytical method.
Time frame: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Population: Number of participants analyzed was determined as participants with treatment-induced ADA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Anti-Drug Antibody (ADA) Titer for PF-05082566 | 14.98 Titer |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Anti-Drug Antibody (ADA) Titer for PF-05082566 | 10.80 Titer |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Anti-Drug Antibody (ADA) Titer for PF-05082566 | 17.25 Titer |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Anti-Drug Antibody (ADA) Titer for PF-05082566 | 8.03 Titer |
Secondary
Anti-Drug Antibody (ADA) Titers for Mogamulizumab
Serum samples were assayed for ADA using a validated analytical method.
Time frame: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Population: Number of participants analyzed was determined as participants with treatment-induced ADA.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Anti-Drug Antibody (ADA) Titers for Mogamulizumab | 1024 Titer |
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.
Time frame: Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1 | 1945 μg*hr/mL | Geometric Coefficient of Variation 25 |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1 | 2124 μg*hr/mL | Geometric Coefficient of Variation 33 |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1 | 2353 μg*hr/mL | Geometric Coefficient of Variation 14 |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1 | 2123 μg*hr/mL | Geometric Coefficient of Variation 24 |
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.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5 | 1143 μg*hr/mL |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5 | 2700 μg*hr/mL |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5 | 3875 μg*hr/mL |
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
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5 | 6868 μg*hr/mL |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5 | 6160 μg*hr/mL |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5 | 6950 μg*hr/mL |
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.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | AUClast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 2001 μg*hr/mL | Geometric Coefficient of Variation 24 |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | AUClast of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 6853 μg*hr/mL | — |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | AUClast of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 5870 μg*hr/mL | — |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | AUClast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 2182 μg*hr/mL | Geometric Coefficient of Variation 36 |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | AUClast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 1382 μg*hr/mL | Geometric Coefficient of Variation 133 |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | AUClast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 2126 μg*hr/mL | Geometric Coefficient of Variation 24 |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | AUClast of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 2310 μg*hr/mL | — |
Secondary
Clearance (CL) of Mogamulizumab-Cycle 5
Clearance (CL) was measured by Dose / AUCtau
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Clearance (CL) of Mogamulizumab-Cycle 5 | 0.146 mL/hr/kg |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Clearance (CL) of Mogamulizumab-Cycle 5 | 0.162 mL/hr/kg |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Clearance (CL) of Mogamulizumab-Cycle 5 | 0.144 mL/hr/kg |
Secondary
Cmax of Mogamulizumab-Cycles 1 and 5
Maximum Observed Serum Concentration (Cmax) was observed directly from the data.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Cmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 18.78 μg/mL | Geometric Coefficient of Variation 19 |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Cmax of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 31.05 μg/mL | — |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Cmax of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 31.90 μg/mL | — |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Cmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 19.73 μg/mL | Geometric Coefficient of Variation 32 |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Cmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 19.77 μg/mL | Geometric Coefficient of Variation 16 |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Cmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 19.82 μg/mL | Geometric Coefficient of Variation 19 |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Cmax of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 32.62 μg/mL | — |
Secondary
Ctrough of Mogamulizumab- Cycle 5
Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.
Time frame: 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
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Ctrough of Mogamulizumab- Cycle 5 | 15.45 μg/mL |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Ctrough of Mogamulizumab- Cycle 5 | 9.040 μg/mL |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Ctrough of Mogamulizumab- Cycle 5 | 15.99 μg/mL |
Secondary
Dose Normalized AUClast of PF-05082566-Cycle 5
Dose normalized AUClast was calculated by AUClast / Dose
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Dose Normalized AUClast of PF-05082566-Cycle 5 | 952.5 µg•hr/mL/mg/kg |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Dose Normalized AUClast of PF-05082566-Cycle 5 | 2490 µg•hr/mL/mg/kg |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Dose Normalized AUClast of PF-05082566-Cycle 5 | 773.0 µg•hr/mL/mg/kg |
Secondary
Dose Normalized Cmax of PF-05082566-Cycle 5
Dose normalized Cmax was calculated by Cmax / Dose
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Dose Normalized Cmax of PF-05082566-Cycle 5 | 15.61 µg/mL/mg/kg |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Dose Normalized Cmax of PF-05082566-Cycle 5 | 25.60 µg/mL/mg/kg |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Dose Normalized Cmax of PF-05082566-Cycle 5 | 21.13 µg/mL/mg/kg |
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.
Time frame: Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months
Population: No participants were enrolled in the dose-expansion portion.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion | DR | — |
| Unknown | Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion | irDR | — |
Secondary
Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5
Maximum Observed Serum Concentration (Cmax) was observed directly from the data.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5 | 18.71 μg/mL |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5 | 27.80 μg/mL |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5 | 105.7 μg/mL |
Secondary
Neutralizing Antibodies (NAb) Titers for Mogamulizumab
ADA positive samples were further analyzed for NAb using a validated assay
Time frame: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Population: Number of participants analyzed was determined as participants with treatment-induced NAb.
Secondary
Neutralizing Antibodies (NAb) Titers for PF-05082566
ADA positive samples were further analyzed for NAb using a validated assay.
Time frame: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Population: Number of participants analyzed was determined as participants with treatment-induced NAb.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Neutralizing Antibodies (NAb) Titers for PF-05082566 | 1.80 Titer |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Neutralizing Antibodies (NAb) Titers for PF-05082566 | 1.30 Titer |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Neutralizing Antibodies (NAb) Titers for PF-05082566 | 2.64 Titer |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Neutralizing Antibodies (NAb) Titers for PF-05082566 | 1.30 Titer |
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).
Time frame: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Population: All enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoglycemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Alkaline phosphatase | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypocalcemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypercalcemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoalbuminemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Bilirubin (total) | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypomagnesemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperglycemia | 1 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypernatremia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | ALT | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyponatremia | 1 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperkalemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Creatinine | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypophosphatemia | 1 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypokalemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypermagnesemia | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | AST | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypermagnesemia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoglycemia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypernatremia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | AST | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoalbuminemia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypocalcemia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyponatremia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Bilirubin (total) | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | ALT | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Creatinine | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypomagnesemia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypercalcemia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Alkaline phosphatase | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperglycemia | 1 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypophosphatemia | 1 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypokalemia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperkalemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoalbuminemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Alkaline phosphatase | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | AST | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Bilirubin (total) | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Creatinine | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypercalcemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperglycemia | 1 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperkalemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypermagnesemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypernatremia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | ALT | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypocalcemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoglycemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypokalemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypomagnesemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyponatremia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypophosphatemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoglycemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperkalemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyperglycemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Alkaline phosphatase | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypokalemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypercalcemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Creatinine | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | ALT | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypomagnesemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Bilirubin (total) | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | AST | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypoalbuminemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypophosphatemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypocalcemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypernatremia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hypermagnesemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hyponatremia | 0 Participants |
Secondary
Number of Participants With Clinical Significant Observations in Vital Signs
Blood pressure (BP) and pulse rate were recorded in supine or sitting position.
Time frame: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Population: All enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Clinical Significant Observations in Vital Signs | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Clinical Significant Observations in Vital Signs | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Clinical Significant Observations in Vital Signs | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Clinical Significant Observations in Vital Signs | 0 Participants |
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.
Time frame: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Population: All enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5 | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5 | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5 | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5 | 0 Participants |
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.
Time frame: Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Population: All enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Anemia | 1 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Platelets | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Neutrophils (absolute) | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hemoglobin increased | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | White blood cells | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphocyte count increased | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphopenia | 6 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Platelets | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphopenia | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphocyte count increased | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Neutrophils (absolute) | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | White blood cells | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hemoglobin increased | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Anemia | 1 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphopenia | 2 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Anemia | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hemoglobin increased | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphocyte count increased | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Neutrophils (absolute) | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Platelets | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | White blood cells | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphocyte count increased | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | White blood cells | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Platelets | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Hemoglobin increased | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Anemia | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Neutrophils (absolute) | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4 | Lymphopenia | 0 Participants |
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.
Time frame: Every 8 weeks up to 24 months
Population: The full analysis set included all enrolled participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | Objective Response | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | immune-related Objective Response | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | immune-related Objective Response | 1 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | Objective Response | 1 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | immune-related Objective Response | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | Objective Response | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | immune-related Objective Response | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR) | Objective Response | 0 Participants |
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.
Time frame: Cycle 2 Day 1; End of the treatment.
Population: All enrolled participants who received at least 1 dose of study treatment. Number analyzed was the number of participants at the given category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | End of Treatment | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | Cycle 2 Day 1 | 1 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | End of Treatment | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | Cycle 2 Day 1 | 1 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | Cycle 2 Day 1 | 1 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | End of Treatment | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | End of Treatment | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Significant Changes From Baseline in Physical Examination | Cycle 2 Day 1 | 0 Participants |
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.
Time frame: Day 1 up to 60 days after last dose of study treatment
Population: All enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | AEs | 11 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | SAEs | 3 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 3 or 4 | 2 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 5 | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | SAEs | 3 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 3 or 4 | 3 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 5 | 2 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | AEs | 6 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 3 or 4 | 2 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | SAEs | 2 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 5 | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | AEs | 4 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 5 | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | SAEs | 2 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | AEs | 3 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (All Causalities) | Grade 3 or 4 | 1 Participants |
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.
Time frame: Day 1 up tp 60 days after last dose of study treatment
Population: All enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | AEs | 7 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | SAEs | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 3 or 4 AEs | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | SAEs | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 3 or 4 AEs | 2 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | AEs | 6 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 3 or 4 AEs | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | SAEs | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | AEs | 4 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | SAEs | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | AEs | 3 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related) | Grade 3 or 4 AEs | 0 Participants |
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.
Time frame: Day 1 up to 60 days after last dose of study treatment
Population: All enrolled participants who received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | AEs | 7 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | SAEs | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 3 or 4 AEs | 0 Participants |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | SAEs | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 3 or 4 AEs | 2 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | AEs | 6 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 3 or 4 AEs | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | SAEs | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | AEs | 3 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 5 AEs | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | SAEs | 0 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | AEs | 3 Participants |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related) | Grade 3 or 4 AEs | 0 Participants |
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
Time frame: 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.
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5 | 1.300 μg/mL |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5 | 1.160 μg/mL |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5 | 3.464 μg/mL |
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.
Time frame: Every 8 weeks up to 24 months
Population: No participants were enrolled in the dose-expansion portion.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion | PFS | — |
| Unknown | Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion | irPFS | — |
Secondary
Time for Cmax (Tmax) of PF-05082566-Cycle 5
Time for Cmax (Tmax) was observed directly from the data.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Time for Cmax (Tmax) of PF-05082566-Cycle 5 | 2.02 hour |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Time for Cmax (Tmax) of PF-05082566-Cycle 5 | 6.00 hour |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Time for Cmax (Tmax) of PF-05082566-Cycle 5 | 1.08 hour |
Secondary
Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5
Time of last measurable concentration was observed directly from data.
Time frame: 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.
Population: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5 | 336 hour |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5 | 309 hour |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5 | 97.6 hour |
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.
Time frame: Every 8 weeks up to 24 months
Population: No participants were enrolled in the dose-expansion portion.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion | TTR | — |
| Unknown | Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion | irTTR | — |
Secondary
Tlast of Mogamulizumab-Cycles 1 and 5
Time of last measurable concentration was observed directly from the data.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Tlast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 166 hour |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Tlast of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 335 hour |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Tlast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 166 hour |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Tlast of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 308 hour |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Tlast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 143 hour |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Tlast of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 107 hour |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Tlast of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 166 hour |
Secondary
Tmax of Mogamulizumab-Cycles 1 and 5
Time for Cmax (Tmax) was observed directly from the data.
Time frame: 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
Population: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Tmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 1.28 hour |
| PF-05082566 1.2 mg/kg + Mogamulizumab 1 mg/kg | Tmax of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 13.5 hour |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Tmax of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 1.05 hour |
| PF-05082566 100 mg + Mogamulizumab 1 mg/kg | Tmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 1.30 hour |
| PF-05082566 2.4 mg/kg + Mogamulizumab 1 mg/kg | Tmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 1.24 hour |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Tmax of Mogamulizumab-Cycles 1 and 5 | Cycle 1 | 1.03 hour |
| PF-05082566 5 mg/kg + Mogamulizumab 1 mg/kg | Tmax of Mogamulizumab-Cycles 1 and 5 | Cycle 5 | 1.05 hour |