Sunitinib Drug Levels and Outcomes in Kidney Cancer (CRESTO)
Correlating Renal Cell Cancer Treatment Efficacy With Sunitinib Therapeutic Levels and Outcomes
Sunitinib is an oral drug used for treatment of advanced kidney cancer. The standard dose is 50mg, but many patients require a dose decrease due to side-effects. Drug levels of sunitinib vary approximately 10-fold between patients.
This study will measure blood levels of sunitinib and its metabolite, and correlate these with side-effects and the response to the treatment. The study aims to establish whether blood levels change with time, and see how useful blood levels are for monitoring patients treated with sunitinib.
연구 개요
상태
정황
상세 설명
Rationale: Sunitinib is an oral multi-targeted tyrosine kinase inhibitor used for first-line systemic therapy in metastatic renal cell carcinoma. It is metabolised to a pharmacologically active metabolite, SU012662, which is of equal potency to the parent compound. At a standard 50mg daily dose, variability in plasma levels between patients is approximately ten-fold. In clinical trials, over 30% of patients require a dose reduction due to toxicity. However, some patients can tolerate up to 100mg without excessive toxicity. It is unknown if sunitinib clearance changes with time. Pre-clinical experiments observed tyrosine kinase inhibition at a plasma concentration of 50-100ng/ml.
Design: This is a prospective non-randomized, Phase II clinical study. Decision to treat patients with single-agent sunitinib is pre-determined by treating specialists before entering this study. Toxicity and trough sunitinib/metabolite levels will be measured every six weeks during treatment.
Aim: This study will prospectively examine the relationship between steady-state trough levels of sunitinib/metabolites and the time on treatment, in addition to changes in trough levels over time. Trough levels will also be correlated with other measures of efficacy and treatment-related toxicity. Furthermore, we aim to confirm that the putative target of 50ng/ml correlates with toxicity and time on sunitinib.
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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New South Wales
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Westmead, New South Wales, 호주, 2145
- 모병
- Crown Princess Mary Cancer Centre, Westmead Hospital
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연락하다:
- Howard Gurney, MBBS (Hon), FRACP
- 전화번호: +61298455200
- 이메일: howard.gurney@sydney.edu.au
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수석 연구원:
- Howard Gurney, MBBS (Hon), FRACP
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Metastatic renal cell cancer treated with single agent sunitinib
- No known primary liver disease and no other severe or uncontrolled concurrent medical conditions
- Signed informed consent
Exclusion Criteria:
- Patients who are unable to sign informed consent
- Patients unable to give blood
- Patients who are pregnant, nursing or not using an effective contraception method
- Patients who had bone-marrow-transplantation prior to sunitinib treatment
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to treatment failure (time on sunitinib treatment)
기간: Sunitinib duration (median)
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This duration extends from the date the patient starts sunitinib until the date sunitinib is abandoned.
The group with sunitinib concentration below the population median are expected to have a median Time to Treatment Failure (TTF) of approximately 8 months, compared with 14 months in those with sunitinib concentration above the population median.
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Sunitinib duration (median)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Toxicity
기간: Every 6 weeks
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Pre-specified toxicities (BP, fatigue, diarrhoea, stomatitis, hand-foot syndrome) will be graded every 6 weeks
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Every 6 weeks
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Overall survival
기간: 2 years
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Measured from the date of starting sunitinib treatment to the date of death from any cause
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2 years
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Progression-free survival
기간: 2 years
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Progression as determined by the clinician according to RECIST 1.1 definitions
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2 years
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Time to second line therapy
기간: 2 years
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Date of starting sunitinib treatment to the date further systemic therapy is started
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2 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Howard Gurney, MBBS, FRACP, Crown Princess Mary Cancer Centre, Westmead
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HGWH008
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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