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PF-04856884 (CVX-060) In Combination With Axitinib In Patients With Previously Treated Metastatic Renal Cell Carcinoma

2018년 12월 19일 업데이트: Pfizer

A PHASE II TRIAL OF PF-04856884 (CVX-060), A SELECTIVE ANGIOPOIETIN-2 (ANG-2) INHIBITOR IN COMBINATION WITH AG-013736 (AXITINIB) IN PATIENTS WITH PREVIOUSLY TREATED METASTATIC RENAL CELL CARCINOMA

To evaluate the combination of PF-04856884 (CVX-060) in combination with Axitinib (AG-013736) in patients that have received one prior systemic regimen for metastatic renal cell carcinoma (mRCC) vs. axitinib alone.

연구 개요

상태

종료됨

정황

개입 / 치료

상세 설명

The study was prematurely discontinued on 06Nov2012 due to tolerability findings in patients treated in Part I of the study that have prompted the Sponsor to re-evaluate the strategic development of the program. An unexpected frequency of arterial thrombotic events (ATEs) and venous thrombotic events (VTEs) were reported in patients treated in Part I.

연구 유형

중재적

등록 (실제)

18

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 미국
    • Arizona
      • Scottsdale, Arizona, 미국, 85258
        • Pinnacle Oncology Hematology
      • Tucson, Arizona, 미국, 85704
        • Arizona Oncology Associates, PC - HOPE
      • Tucson, Arizona, 미국, 85710
        • Arizona Oncology Associates, PC-Hope
    • Colorado
      • Aurora, Colorado, 미국, 80012
        • Rocky Mountain Cancer Centers
      • Boulder, Colorado, 미국, 80303
        • Rocky Mountain Cancer Centers
      • Centennial, Colorado, 미국, 80112
        • Rocky Mountain Cancer Centers
      • Colorado Springs, Colorado, 미국, 80907
        • Rocky Mountain Cancer Centers
      • Colorado Springs, Colorado, 미국, 80909
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, 미국, 80218
        • Rocky Mountain Cancer Centers
      • Denver, Colorado, 미국, 80220
        • Rocky Mountain Cancer Centers
      • Lakewood, Colorado, 미국, 80228
        • Rocky Mountain Cancer Centers
      • Littleton, Colorado, 미국, 80120-4413
        • Rocky Mountain Cancer Centers
      • Lone Tree, Colorado, 미국, 80124
        • Rocky Mountain Cancer Centers
      • Longmont, Colorado, 미국, 80501
        • Rocky Mountain Cancer Centers
      • Parker, Colorado, 미국, 80138
        • Rocky Mountain Cancer Centers
      • Pueblo, Colorado, 미국, 81008
        • Rocky Mountain Cancer Centers
      • Thornton, Colorado, 미국, 80260
        • Rocky Mountain Cancer Centers
    • Nebraska
      • Omaha, Nebraska, 미국, 68114
        • Nebraska Methodist Hospital
    • Nevada
      • Henderson, Nevada, 미국, 89074
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, 미국, 89052
        • Comprehensive Cancer Centers of Nevada
      • Henderson, Nevada, 미국, 89014
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, 미국, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, 미국, 89128
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, 미국, 89169
        • Comprehensive Cancer Centers of Nevada
    • North Carolina
      • Durham, North Carolina, 미국, 27704
        • Regional Cancer Care-Durham
    • Texas
      • Tyler, Texas, 미국, 75702
        • Texas Oncology-Tyler
    • Washington
      • Seattle, Washington, 미국, 98109
        • Seattle Cancer Care Alliance
      • Seattle, Washington, 미국, 98195
        • University of Washington Medical Center
  • 체코
      • Brno, 체코, 65653
        • Masarykuv onkologicky ustav

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:

  • Adult male or female patients with histologically or cytologically confirmed renal cell cancer (RCC) with a component of clear cell subtype and evidence of metastasis
  • Evidence of unidimensionally measurable disease
  • Prior therapy: Part I: Having received 1 to 3 prior systemic regimens for treatment of mRCC
  • Part II: Evidence of disease progression following 1 prior regimen administered as 1st line therapy for mRCC. The prior regimen must have contained one of the following: VEGFR2 tyrosine kinase inhibitor (TKI) or other anti VEGF [Vascular Endothelial Growth Factor] compounds, such as bevacizumab
  • adequate bone marrow, liver and renal function

Exclusion Criteria:

Part I:

  • Intolerant to prior AG 013736 therapy or prior treatment with compounds which contain the core platform antibody as PF 04856884

Part II:

  • Prior AG 013736 therapy, more than one systemic first-line regimen for the treatment of mRCC and prior treatment with compounds which contain the core platform antibody as PF 04856884
  • major surgery <4 weeks or radiation therapy <2 weeks prior to start of therapy
  • clinically significant gastrointestinal abnormalities
  • current use or anticipated need for drugs that are known potent CYP3A4 inhibitors and drugs that are known CYP3A4 or CYP1A2 inducers
  • history of bleeding diathesis or coagulopathy
  • Grade 3 or greater hemorrhage from any cause <4 weeks prior to screening;
  • hemoptysis >½ teaspoon of blood per day within 2 weeks prior to screening.

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
  • 할당: 무작위
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: ARM A
PF-04856884 in combination with AG-013736
생물학적: PF-04856884
15 mg/kg/week intravenously [IV] until toxicity or disease progression
의약품: Axitinib (AG-013736)
5 mg PO BID
활성 비교기: ARM B
AG-013736 alone
의약품: Axitinib (AG-013736)
5 mg PO BID

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Non-serious Adverse Events (AEs) in Part I (Reported in ≥2 of the Participants Overall).
기간: 4 months

Incidence and severity of all treatment-emergent AEs (TEAEs) of both all-causality and treatment-related by preferred term (PT) categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades reported in ≥2 participants overall (CTCAE Grades 3, 4 and 5, combined) for any PT are presented. Participants who are included under all-causality TEAE PT are coded as NA if they appear for the same PT under treatment-related TEAE below.

Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
4 months
Number of Participants With Serious Adverse Events (SAEs) in Part I
기간: 4 months
Incidence and severity of all-causality serious adverse events (SAEs) are presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week). Participants with treatment-related TEAE are coded as NA if they appear for the same preferred term under all-causality TEAE.
4 months
Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) in Part II
기간: 3 years
PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. Progression free survival was to be calculated as (first event date - the date of randomization +1).
3 years

2차 결과 측정

결과 측정
측정값 설명
기간
Number of Participants With Non-serious AEs and SAEs
기간: 3 years
Incidence and severity of all-causality AEs and SAEs to be presented by PT categorized according to Common Terminology Criteria for Adverse Events (CTCAE) grades. Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice daily. Following the decision on 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
3 years
Overall Response Rate (ORR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone.
기간: 4 months
ORR is defined as the proportion of participants with confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST), relative to all randomized participants as defined in the FA Set. Confirmed responses are those that persist on repeat imaging study ≥ 4 weeks after initial documentation of response. Participants who do not have on-study radiographic tumor evaluation or who die, progress, or drop out for any reason prior to reaching a CR or PR will be counted as non-responders (NR) in the assessment of ORR.
4 months
Duration of Response (DR) in Metastatic Renal Cell Cancer (mRCC) Patients Treated With PF-04856884 in Combination With AG-013736 vs. AG-013736 Alone
기간: 3 years
DR is defined as the time from the first documentation of objective tumor response (CR or PR) that is subsequently confirmed to the first documentation of tumor progression or to death due to cancer. Duration of tumor response was to be calculated as (the end date for DR - first CR or PR that is subsequently confirmed +1).
3 years
Tmax (Time When Maximum Serum PF-04856884 Concentration Was Reached)
기간: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Pharmacokinetic parameter, Tmax (Time when maximum serum PF-04856884 concentration was reached) was done using non-compartmental methods.
Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Cmax (Observed Peak Serum PF-04856884 Concentration)
기간: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Pharmacokinetic parameter Cmax (observed peak PF-04856884 serum concentration) was estimated using noncompartmental methods.
Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Cmin (Trough PF-04856884 Serum Concentration)
기간: Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Pharmacokinetic parameter Cmin (trough PF-04856884 serum concentration) was estimated using noncompartmental methods.
Pre-dose, 1, 2, 4, 6, 8, 192, 360, 361, 362, 365, 367 hours post dose and end of treatment
Number of Anti-drug Antibodies (ADA) Samples Confirmed Positive
기간: 0 and 360 hours post dose and end of study
Detection of neutralizing anti-PF-04856884 antibodies was based on the ability of anti-PF-04856884 neutralizing antibodies to bind to Tag-PF-04856884.
0 and 360 hours post dose and end of study
Progression Free Survival (PFS) in Adult Participants With Previously Treated Metastatic Renal Cell Cancer (mRCC) as Measured by an Independent Radiological Assessment
기간: 3 years
PFS is defined as the time (in days) from date of randomization to first documentation of investigator assessed tumor progression or death, whichever comes first. PFS was to be calculated as (first event date - the date of randomization +1).
3 years
Overall Survival (OS) at 2 Years
기간: 5 years
OS is defined as the time from the first dose date to date of death. For participants not expiring, their survival times will be censored at the last date they are known to be alive, or 2 year whichever is earlier. The 2-year OS rate will be estimated from a time-to event analysis of OS.
5 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Pfizer

간행물 및 유용한 링크

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

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)

2011년 11월 21일

기본 완료 (실제)

2014년 3월 27일

연구 완료 (실제)

2014년 3월 27일

연구 등록 날짜

최초 제출

2011년 8월 26일

QC 기준을 충족하는 최초 제출

2011년 9월 23일

처음 게시됨 (추정)

2011년 9월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2019년 1월 8일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 12월 19일

마지막으로 확인됨

2018년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • B1131004
  • 2011-002190-33 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

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. .

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