- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01009177
Effect of Bosentan in Patients With Metastatic Melanoma Treated With Dacarbazine (DTIC)
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Effect of Bosentan in Patients With Stage IV Metastatic Melanoma Treated With Dacarbazine
연구 개요
상세 설명
This is a randomized, double-blind (1:1 bosentan : placebo) trial to evaluate the effect of bosentan in combination with DTIC on TTP or death in patients with metastatic melanoma stage IV.
The patients will receive study medication (bosentan or placebo) and DTIC for 35 weeks to 105 weeks; the study will be completed when 66 events (tumor progression, death due to underlying disease, other/additional anti-tumor therapy) have been observed.
Study drug will be administered orally, 500 mg twice a day. DTIC will be given once every three weeks in a dosage of 1000 mg/m2 intravenously (i.v.) or in accordance with the Institution's DTIC treatment protocol.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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-
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Geelong, 호주, VIC 3220
- Barwon Health - The Geelong Hospital
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Hornsby, 호주, NSW
- Sydney Haematology and Oncology Unit
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Malvern, 호주, VIC 2144
- Cabrini Hopsital - Oncology Department
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New Castle, 호주, NSW
- New Castle Melanoma Unit
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Perth, 호주, WA
- Mount Medical Centre
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Redcliffe, 호주, QLD 4020
- Redcliffe Hospital - Dept Oncology & Palliative Care
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South Brisbane, 호주, QLD 4001
- Mater Adult Hospital
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Southport, 호주, QLD 4215
- Pacific Private Clinic
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St Leonards, 호주, NSW
- Royal North Shore Hospital
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Sydney, 호주, NSW
- Sydney Cancer Centre, Royal Prince Alfred Hospital
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Westmead, 호주, NSW 2145
- Westmead Hospital - Department of Oncology
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Wollongong, 호주, NSW
- Southern Medical Day Care Centre
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-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male or female patients 18 years of age or older
- Histologically proven malignant melanoma (Balch et al., J. Clin Oncol. 19(16): 3635-48, 2001) with stage IV measurable disease as defined by RECIST criteria (Therasse et al., J Natl Cancer Inst, 92(3): 205-16, 2000).
- Patients with prior radiation therapy (> 30 days prior to study drug initiation) will be allowed provided the indicator lesion(s) used for this study was (were) outside the field of radiation or represent new lesions not previously irradiated.
- Patients who had no prior therapy with DTIC.
- Patients with cutaneous melanoma lesions must consent to having a biopsy obtained during the screening period and at the end of treatment for exploratory analysis of endothelin receptor expression. Biopsies obtained prior to the study that have been frozen in accordance with procedures specified for this protocol may be used.
- ECOG performance status (≤ 2)
- Life expectancy > 12 weeks
- Female patients must be non-pregnant, non-breast feeding, and either post menopausal, surgically sterile, or practicing a reliable method of contraception (hormonal methods alone are not sufficient)
- Provide written informed consent
- Willing to return to study center for follow up
Exclusion Criteria:
- ALT and/or AST > 3 × the upper limit of normal (ULN) at screening OR ALT and /or AST > 2 x ULN and total bilirubin > 2.0 mg/dl at screening
- Lactate dehydrogenase > 1.5 x ULN
- Hemoglobin >30% below the lower limit of normal
- Systolic blood pressure < 85 mmHg
- NYHA class III/IV congestive heart failure
- Any prior chemotherapy, biological therapy or immunotherapy for stage IV metastatic disease.
- Received immunotherapy < 30 days before treatment start (completed adjuvant immunotherapy for previous resected metastatic disease is allowed)
- Concurrent use of calcineurin inhibitors (cyclosporine A, tacrolimus), sirolimus, fluconazole or glibenclamide (glyburide) or expected to receive any of these drugs during the study at inclusion and during the study.
- History of other malignancy in the last 5 years, with the exception of squamous cell carcinoma of the skin treated with local resection and basal cell carcinoma
- CNS metastases or carcinomatous meningitis
- Ocular melanoma
- Known hypersensitivity to any excipients of Tracleer™
- Prior therapy with bosentan
- Use of therapy with another investigational drug within 4 weeks of the start of dosing with bosentan or plan to receive such treatment during the study
- Known drug or alcohol dependence or any other factor that will interfere with the conduct of the study
- Any standard contraindications for the use of DTIC as per Australian package insert
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: 위약
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위약
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실험적: 보센탄
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Bosentan 500 mg bid
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Time to tumor progression (TTP) or death (progression free survival) after initiation of treatment. Tumor progression is defined per RECIST criteria.
기간: 6 weekly
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6 weekly
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2차 결과 측정
결과 측정 |
기간 |
---|---|
• Tumor response rate • Duration of overall response • Best overall response • Survival will be assessed at 12 months after initiation of study drug and every year thereafter for 5 years
기간: 6 weekly
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6 weekly
|
공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Andjela Kusic-Pajic, MD, Actelion Pharmaceuticals Australia Pty. Ltd
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
- AC-052-281
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. .
위약에 대한 임상 시험
-
Assistance Publique - Hôpitaux de Paris아직 모집하지 않음
-
University Hospital, Strasbourg, France모집하지 않고 적극적으로
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AJU Pharm Co., Ltd.OM Pharma SA모병