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Trial record 1 of 1 for:    NCT02444793
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A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors

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ClinicalTrials.gov Identifier: NCT02444793
Recruitment Status : Terminated (The study was terminated due to marginal efficacy and change in sponsor prioritization. The combination had a manageable safety profile.)
First Posted : May 14, 2015
Results First Posted : February 15, 2019
Last Update Posted : February 27, 2019
Sponsor:
Collaborator:
Kyowa Kirin Co., Ltd.
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE May 12, 2015
First Posted Date  ICMJE May 14, 2015
Results First Submitted Date  ICMJE September 26, 2018
Results First Posted Date  ICMJE February 15, 2019
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE May 2015
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
Number of Participants With Dose Limiting Toxicities (DLT) [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
Number of participant with Dose-Limiting Toxicities (DLTs) [ Time Frame: First 2 cycles of treatment ]
DLTs of PF-05082566 in combination with KW-0761 occurred during the first 2 treatment cycles
Change History Complete list of historical versions of study NCT02444793 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2018)
  • Number of Participants With Treatment-Emergent Adverse Events (All Causalities) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ 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. ]
    Maximum Observed Serum Concentration (Cmax) was observed directly from the data.
  • Dose Normalized Cmax of PF-05082566-Cycle 5 [ 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. ]
    Dose normalized Cmax was calculated by Cmax / Dose
  • Cmax of Mogamulizumab-Cycles 1 and 5 [ 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 ]
    Maximum Observed Serum Concentration (Cmax) was observed directly from the data.
  • Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5 [ 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. ]
    Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data
  • Ctrough of Mogamulizumab- Cycle 5 [ 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 ]
    Pre-dose Concentration during Multiple Dosing (Ctrough) was observed directly from data.
  • Time for Cmax (Tmax) of PF-05082566-Cycle 5 [ 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. ]
    Time for Cmax (Tmax) was observed directly from the data.
  • Time of Last Measurable Concentration (Tlast) of PF-05082566-Cycle 5 [ 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. ]
    Time of last measurable concentration was observed directly from data.
  • Tmax of Mogamulizumab-Cycles 1 and 5 [ 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 ]
    Time for Cmax (Tmax) was observed directly from the data.
  • Tlast of Mogamulizumab-Cycles 1 and 5 [ 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 ]
    Time of last measurable concentration 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 [ 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. ]
    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 [ 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. ]
    Dose normalized AUClast was calculated by AUClast / Dose
  • AUClast of Mogamulizumab-Cycles 1 and 5 [ 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 ]
    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 [ Time Frame: 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 [ 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 ]
    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 [ 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 ]
    Clearance (CL) was measured by Dose / AUCtau
  • Anti-Drug Antibody (ADA) Titer for PF-05082566 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
  • Maximum plasma concentration (Cmax) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Cmax is defined as the maximum plasma concentration of PF-05082566
  • Maximum plasma concentration (Cmax) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Cmax is defined as the maximum plasma concentration of KW-0761
  • Time to reach the maximum plasma concentration (Tmax) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Tmax is the time needed from the start of infusion, to reach the maximum plasma concentration of PF-05082566
  • Time to reach the maximum plasma concentration (Tmax) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Tmax is the time needed from the start of infusion, to reach the maximum plasma concentration of KW-0761
  • Trough plasma concentration (Ctrough) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Ctrough is defined as the concentration at the end of PF-05082566 dosage interval
  • Trough plasma concentration (Ctrough) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Ctrough is defined as the concentration at the end of KW-0761 dosage interval
  • Area Under the Curve0-last (AUC0-last) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    AUC0-last is the area under the curve from time 0 to last measurable concentration of PF-05082566
  • Area Under the Curve0-last (AUC0-last) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    AUC0-last is the area under the curve from time 0 to last measurable concentration of KW-0761
  • Area Under the Curve0-inf (AUC0-inf) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    AUC0-inf is the area under the curve from time 0 to infinite concentration of PF-05082566
  • Area Under the Curve0-inf (AUC0-inf) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    AUC0-inf is the area under the curve from time 0 to infinite concentration of KW-0761
  • Elimination half life (t½) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    t1/2 is defined as the time required for the concentration of PF-05082566 to reach half of its original value.
  • Elimination half life (t½) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    t1/2 is defined as the time required for the concentration of KW-0761 to reach half of its original value.
  • Volume of distribution (Vd) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Vd is defined as the theoretical volume in which the total amount of PF-05082566 would need to be uniformly distributed to produce the desired blood concentration of PF-05082566.
  • Volume of distribution (Vd) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Vd is defined as the theoretical volume in which the total amount of KW-0761 would need to be uniformly distributed to produce the desired blood concentration of KW-0761
  • Total body Clearance (CL) of PF-05082566 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Clearance (CL) is defined as the volume of plasma that would contain the amount of PF-05082566 excreted per minute
  • Total body Clearance (CL) of KW-0761 [ Time Frame: Cycles 1 - 5, 6, 8, 10, 12, 16, 20, 24 up to 24 months ]
    Clearance (CL) is defined as the volume of plasma that would contain the amount of KW-0761 excreted per minute
  • Anti-Drug Antibody (ADA) levels of PF-05082566/Neutralizing antibodies (Nab) titers for PF-05082566 [ Time Frame: Cycles 1, 3, 5, 6, 8, 10 ,12, 16, 20, 24 up to 24 months ]
    Immunogenicity assessments of PF-05082566
  • Anti-Drug Antibody (ADA) levels of KW-0761/Neutralizing antibodies (Nab) titers for KW-0761 [ Time Frame: Cycles 1, 3, 5, 6, 8, 10 ,12, 16, 20, 24 up to 24 months ]
    Immunogenicity assessments of KW-0761
  • Number of participants with Objective Response [ Time Frame: Every 8 weeks up to 24 months ]
    Number of participants with objective response (ie, confirmed complete or partial response according to RECIST version 1.1 and Immune Related Response Criteria (irRC))
  • Duration of Response (DR) [ Time Frame: Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months ]
    For participants in the expansion cohorts, who achieved on treatment a complete (CR) or partial (PR) response as per RECIST version 1.1 and irRC. DR is the time in days between the first date of documentation of CR or PR and the date of tumor progression or death due to any cause, whichever occurred first
  • Time to Response (TTR) [ Time Frame: Every 8 weeks up to 24 months ]
    For participant to the expansion cohort only. TTR is defined as time from the date of the first dose of study treatment to the date of the first documented objective response by RECIST version 1.1 and irRC
  • Progression Free Survival (PFS) [ Time Frame: Every 8 weeks up to 24 months ]
    For participants to the expansion cohorts only. PFS is defined as the difference in days between the first date that criteria for progression (by RECIST v 1.1 and irRC) was met or the patient died due to any cause and the date of registration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
Official Title  ICMJE A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced/Metastatic Solid Tumors
Intervention  ICMJE
  • Drug: PF-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.
  • Drug: KW-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.
    Other Name: KW-0761= Mogamulizumab or POTELIGEO®
Study Arms  ICMJE Experimental: PF-05082566 + KW-0761
During Parts 1 & 2 Mogamulizumab and PF-05082566 will be administered at appropriate intervals. Part 1: PF-05082566 dose escalation; increased doses of PF-05082566 IV are administered with mogamulizumab IV. Part 2: patients will be treated with the maximum tolerated dose established in Phase 1 for the combination.
Interventions:
  • Drug: PF-05082566
  • Drug: KW-0761
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 8, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: May 12, 2015)
70
Actual Study Completion Date  ICMJE October 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02444793
Other Study ID Numbers  ICMJE B1641004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Kyowa Kirin Co., Ltd.
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
Principal Investigator: Michael J Pishvaian, MD, PhD Georgetown University
Principal Investigator: Esra E Cohen, MD University of California, San Diego
Principal Investigator: Dale R Shepard, MD, PhD The Cleveland Clinic
PRS Account Pfizer
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP