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A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors

2019년 2월 13일 업데이트: Pfizer

A PHASE 1B STUDY OF PF-05082566 IN COMBINATION WITH MOGAMULIZUMAB (KW-0761) IN PATIENTS WITH ADVANCED SOLID TUMORS

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.

연구 개요

상태

종료됨

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

24

단계

  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • California
      • La Jolla, California, 미국, 92093
        • University of California San Diego Moores Cancer Center
      • La Jolla, California, 미국, 92037-0845
        • UC San Diego Moores Cancer Center
      • La Jolla, California, 미국, 92037
        • UC San Diego Medical Center - La Jolla(Thornton Hospital)
      • La Jolla, California, 미국, 92093
        • University Of California / San Diego Moores Cancer Center
      • San Diego, California, 미국, 92103
        • UC San Diego Medical Center - Hillcrest
    • District of Columbia
      • Washington, District of Columbia, 미국, 20007
        • Georgetown University Medical Center
      • Washington, District of Columbia, 미국, 20007
        • MedStar Georgetown University Hospital
      • Washington, District of Columbia, 미국, 20007
        • Georgetown University
    • Florida
      • Tampa, Florida, 미국, 33612
        • Moffitt Cancer Center and Research Institute
    • Michigan
      • Detroit, Michigan, 미국, 48202
        • Henry Ford Hospital
      • Detroit, Michigan, 미국, 48202
        • Henry Ford Hospital Research Pharmacy
    • North Carolina
      • Chapel Hill, North Carolina, 미국, 27514
        • UNC Cancer Hospital Infusion Pharmacy
      • Chapel Hill, North Carolina, 미국, 27599-7600
        • UNC Hospitals, University of North Carolina at Chapel Hill
    • Ohio
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, 미국, 44195
        • Cleveland Clinic Taussig Cancer Institute
    • South Dakota
      • Sioux Falls, South Dakota, 미국, 57104
        • Sanford Cancer Center
      • Sioux Falls, South Dakota, 미국, 57105
        • Sanford USD Medical Center
      • Sioux Falls, South Dakota, 미국, 57104
        • Sanford Research
    • Tennessee
      • Gallatin, Tennessee, 미국, 37066
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, 미국, 37203
        • Tennessee Oncology, PLLC
      • Nashville, Tennessee, 미국, 37203
        • The Sarah Cannon Research Institute

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
의약품: 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.
다른 이름들:
  • KW-0761= Mogamulizumab or POTELIGEO®

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Dose Limiting Toxicities (DLT)
기간: 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.
First 2 Cycles (28 days in each cycle)

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Treatment-Emergent Adverse Events (All Causalities)
기간: 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.
Day 1 up to 60 days after last dose of study treatment
Number of Participants With Treatment-Emergent Adverse Events (PF-05082566 Related)
기간: 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.
Day 1 up to 60 days after last dose of study treatment
Number of Participants With Treatment-Emergent Adverse Events (Mogamulizumab Related)
기간: 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.
Day 1 up tp 60 days after last dose of study treatment
Number of Participants With Hematology Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4
기간: 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.
Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Number of Participants With Chemistries Laboratory Abnormalities as Characterized by Type, Frequency, Severity (as Graded by NCI CTCAE) -Grades 3 or 4
기간: 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).
Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Number of Participants With Clinical Significant Observations in Vital Signs
기간: 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.
Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Number of Participants With Significant Changes From Baseline in Physical Examination
기간: 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.
Cycle 2 Day 1; End of the treatment.
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status Shift to Grades 2, 3, 4 or 5
기간: 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.
Screening (within 28 days prior to registration) up to 28 days (+7 days) after the last dose of study treatment
Maximum Observed Serum Concentration (Cmax) of PF-05082566-Cycle 5
기간: 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.
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 of PF-05082566-Cycle 5
기간: 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
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.
Cmax of Mogamulizumab-Cycles 1 and 5
기간: 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.
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
Pre-dose Concentration During Multiple Dosing (Ctrough) of PF-05082566-Cycle 5
기간: 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
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.
Ctrough of Mogamulizumab- Cycle 5
기간: 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.
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) of PF-05082566-Cycle 5
기간: 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.
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 (Tlast) of PF-05082566-Cycle 5
기간: 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.
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.
Tmax of Mogamulizumab-Cycles 1 and 5
기간: 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.
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
Tlast of Mogamulizumab-Cycles 1 and 5
기간: 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.
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
Area Under the Serum Concentration-time Profile From Time 0 to the Time of the Last Measurable Concentration (AUClast) of PF-05082566-Cycle 5
기간: 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.
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 of PF-05082566-Cycle 5
기간: 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
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 of Mogamulizumab-Cycles 1 and 5
기간: 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.
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
Area Under the Serum Concentration-time Profile From Time 0 to 168 Hours (AUC168) of Mogamulizumab-Cycle 1
기간: 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.
Cycle 1: pre-dose and at the end of mogamulizumab infusion on Days 1, 8, 15 and 22
Area Under the Serum Concentration-time Profile From Time 0 to Time Tau (AUCtau) of Mogamulizumab-Cycle 5
기간: 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
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) of Mogamulizumab-Cycle 5
기간: 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
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
Anti-Drug Antibody (ADA) Titer for PF-05082566
기간: 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.
Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Neutralizing Antibodies (NAb) Titers for PF-05082566
기간: 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.
Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Anti-Drug Antibody (ADA) Titers for Mogamulizumab
기간: 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.
Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Neutralizing Antibodies (NAb) Titers for Mogamulizumab
기간: 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
Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 12, 16, 20, 24 up to 24 months
Number of Participants With Objective Response (OR) and Immune-related Objective Response (irOR)
기간: 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.
Every 8 weeks up to 24 months
Time to Response (TTR) and Immue-related Time to Response (irTTR)-Dose Expansion Portion
기간: 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.
Every 8 weeks up to 24 months
Duration of Response (DR) and Immune-related DR (irDR) -Dose Expansion Portion
기간: 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.
Every 8 weeks from the first occurrence of CR or PR, until disease progression or death up to 24 months
Progression Free Survival (PFS) and Immune-related PFS (irPFS) - Dose Expansion Portion
기간: 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.
Every 8 weeks up to 24 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

협력자

Kyowa Kirin Co., Ltd.

수사관

  • 수석 연구원: Michael J Pishvaian, Md, PhD, Georgetown University
  • 수석 연구원: Esra E Cohen, MD, University of California, San Diego
  • 수석 연구원: Dale R Shepard, MD, PhD, The Cleveland Clinic

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

유용한 링크

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2015년 5월 1일

기본 완료 (실제)

2017년 9월 1일

연구 완료 (실제)

2017년 10월 1일

연구 등록 날짜

최초 제출

2015년 5월 12일

QC 기준을 충족하는 최초 제출

2015년 5월 12일

처음 게시됨 (추정)

2015년 5월 14일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 2월 27일

QC 기준을 충족하는 마지막 업데이트 제출

2019년 2월 13일

마지막으로 확인됨

2019년 2월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B1641004

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

IPD 계획 설명

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.

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

PF-05082566에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Saint Lucia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

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