A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma.
2010년 10월 8일 업데이트: Pfizer
A Pivotal Study Of SU011248 In The Treatment Of Patients With Cytokine-Refractory Metastatic Renal Cell Carcinoma
To assess the safety and efficacy of SU011248 in patients with metastatic, refractory renal cell carcinoma
연구 개요
연구 유형
중재적
등록 (실제)
106
단계
- 2 단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Duarte, California, 미국, 91010-3000
- Pfizer Investigational Site
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Pasadena, California, 미국, 91105
- Pfizer Investigational Site
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San Francisco, California, 미국, 94115
- Pfizer Investigational Site
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- Pfizer Investigational Site
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Boston, Massachusetts, 미국, 02115
- Pfizer Investigational Site
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Boston, Massachusetts, 미국, 02215
- Pfizer Investigational Site
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- Pfizer Investigational Site
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Minnesota
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Rochester, Minnesota, 미국, 55905
- Pfizer Investigational Site
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New York
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New York, New York, 미국, 10021
- Pfizer Investigational Site
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New York, New York, 미국, 10022
- Pfizer Investigational Site
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North Carolina
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Durham, North Carolina, 미국, 27705
- Pfizer Investigational Site
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Ohio
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Cleveland, Ohio, 미국, 44195
- Pfizer Investigational Site
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Oregon
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Portland, Oregon, 미국, 97213
- Pfizer Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19111
- Pfizer Investigational Site
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- Pfizer Investigational Site
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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:
- Cytokine refractory metastatic renal cell carcinoma with clear cell component
- Radiographic evidence of disease progression during or within 9 months of completion of 1 cytokine therapy
- Prior nephrectomy
Exclusion Criteria:
- Prior treatment with any systemic therapy other than 1 cytokine therapy
- History of or known brain metastases
- Uncontrolled hypertension or other significant cardiac events within the 12 months prior to study start
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: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 1
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50-mg orally taken daily for 4 weeks and off treatment for 2 weeks until progression or unacceptable toxicity
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of Subjects With Confirmed Objective Response According to Response Evaluation Criteria in Solid Tumors(RECIST)
기간: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Overall confirmed objective response = confirmed Complete Response (CR) or confirmed Partial Response (PR) according to RECIST.
CR defined as disappearance of all target lesions.
PR defined as >= 30 percent decrease in the sum of the longest dimensions of the target lesions taking as a reference the baseline sum longest dimensions.
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Tumor Progression (TTP)
기간: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to cancer, whichever comes first.
TTP was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]).
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter
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Duration of Response (DR)
기간: Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Time in weeks from the first documentation of objective tumor response to objective tumor progression or death due to any cancer. Duration of tumor response was calculated as (the date of the first documentation of objective tumor progression or death due to cancer minus the date of the first CR or PR that was subsequently confirmed plus 1) divided by 7. DR was calculated for the subgroup of patients with a confirmed objective tumor response. |
Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death due to cancer
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Overall Survival (OS)
기간: From start of study treatment until death
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Time in weeks from the start of study treatment to date of death due to any cause.
OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 7. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the subject current status was death).
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From start of study treatment until death
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Progression-free Survival (PFS)
기간: From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Time in weeks from start of study treatment to first documentation of objective tumor progression or death due to any cause.
PFS was calculated as (first event date minus the date of first dose of study medication plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").
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From start of study treatment until Day 28 of Cycles 1-5, Day 28 of even Cycles thereafter or death
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Percent Chance of Patient Survival
기간: From start of study treatment until death
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Probability of survival 1 year and 2 years after the first dose of study treatment
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From start of study treatment until death
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Observed Plasma Trough Concentrations of Sunitinib
기간: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Metabolite
기간: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed Plasma Trough Concentrations of Sunitinib Plus Metabolite
기간: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Observed plasma trough (predose) concentrations of sunitinib plus its metabolite (SU012662)
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib
기간: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib.
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Metabolite
기간: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose Corrected Plasma Trough Concentrations of Sunitinib Plus Metabolite
기간: Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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Dose corrected plasma trough (predose) (Cmin) concentrations of sunitinib plus its metabolite (SU012662).
Dose-corrected trough concentrations were set to missing for trough samples collected outside acceptable times from dose administration, samples not collected within scheduled day range, samples with missing collection or administration dates or times, samples collected with dose interruption, and samples collected with inconsistent dose level within 10 days of last dose date.
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Day 28 of Cycle 1 through 4, Day 1 of Cycles 5 and greater
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
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
- de Velasco G, McKay RR, Lin X, Moreira RB, Simantov R, Choueiri TK. Comprehensive Analysis of Survival Outcomes in Non-Clear Cell Renal Cell Carcinoma Patients Treated in Clinical Trials. Clin Genitourin Cancer. 2017 Dec;15(6):652-660.e1. doi: 10.1016/j.clgc.2017.03.004. Epub 2017 Mar 21.
- Grunwald V, Lin X, Kalanovic D, Simantov R. Early Tumour Shrinkage: A Tool for the Detection of Early Clinical Activity in Metastatic Renal Cell Carcinoma. Eur Urol. 2016 Dec;70(6):1006-1015. doi: 10.1016/j.eururo.2016.05.010. Epub 2016 May 26.
- Grunwald V, McKay RR, Krajewski KM, Kalanovic D, Lin X, Perkins JJ, Simantov R, Choueiri TK. Depth of remission is a prognostic factor for survival in patients with metastatic renal cell carcinoma. Eur Urol. 2015 May;67(5):952-8. doi: 10.1016/j.eururo.2014.12.036. Epub 2015 Jan 7.
- Motzer RJ, Rini BI, Bukowski RM, Curti BD, George DJ, Hudes GR, Redman BG, Margolin KA, Merchan JR, Wilding G, Ginsberg MS, Bacik J, Kim ST, Baum CM, Michaelson MD. Sunitinib in patients with metastatic renal cell carcinoma. JAMA. 2006 Jun 7;295(21):2516-24. doi: 10.1001/jama.295.21.2516.
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
2004년 2월 1일
기본 완료 (실제)
2008년 9월 1일
연구 완료 (실제)
2008년 9월 1일
연구 등록 날짜
최초 제출
2004년 2월 13일
QC 기준을 충족하는 최초 제출
2004년 2월 17일
처음 게시됨 (추정)
2004년 2월 18일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2010년 10월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2010년 10월 8일
마지막으로 확인됨
2010년 10월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- A6181006
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. .