- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00971126
Study of Sorafenib With Combination of Thalidomide in Hepatocellular Carcinoma (HCC)
A Phase I/II Study of Sorafenib With Combination of Thalidomide in Advanced or Metastatic Hepatocellular Carcinoma
The purpose of this phase I study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC.
The Phase II purpose of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC.
연구 개요
상세 설명
This is a non-randomized, open-labeled, single-arm, multi-center, phase I /II clinical study. The Phase I purpose of this study is to determine the maximal tolerable dose (MTD) of thalidomide (THADO®) in combination with fixed dose of sorafenib (NEXAVAR®) for the treatment of advanced or metastatic HCC, and the dose-limiting toxicity (DLT) profiles and other toxicity profiles in patients receiving fixed dose of sorafenib (NEXAVAR®) plus escalating dose of thalidomide (THADO). The Phase II primary objective of this study is to determine the disease control rate (complete response + partial response + stable disease) for at least 4 months of sorafenib (NEXAVAR®) plus phase I determined MTD of thalidomide (THADO®) in patients with advanced or metastatic HCC. The Phase II secondary objective of this study is to determine the objective tumor response rate, the time to tumor progression, the progression-free survival, the overall survival, and the safety and adverse event profiles, the changes of circulating biomarkers relating to angiogenesis and their correlation with disease control rate.
The sample size are required up to 24 patients for the phase I study and 53 patients for the phase II study.
Sorafenib (NEXAVAR®): supplied to Good Manufacturing Practice standards by Bayer Health Care, Taiwan as a film-coated tablet, each of which contains sorafenib tosylate (274mg) equivalent to 200 mg of sorafenib. Thalidomide (THADO®): supplied to Good Manufacturing Practice standards by TTY Biopharm Co., Ltd. as a white-yellow capsule, each of which contains 50 mg of thalidomide.
연구 유형
등록 (실제)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 장소
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Chia-Yi, 대만, 613
- Ghang-Gung Memorial Hospital at Chia-Yi
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients must be at least 18 years of age.
- With histologically or cytologically documented HCC or clinically diagnosed HCC.
- Advanced (surgically unresectable and unsuitable for local therapy), and/or metastatic HCC, and/or patient refused local therapy.
- Performance status of ECOG score 0-2.
- Life expectancy of at least 12 weeks.
At least one tumor lesion that meets both of the following criteria:
- measurable (must be by CT-scan or MRI) in at least one dimension according to RECIST;
- the lesion has not been previously treated with local therapy, such as radiation therapy, hepatic arterial (chemo) embolization, radiofrequency ablation, and percutaneous interventional therapy.
- Previous local therapy, such as radiotherapy, hepatic arterial (chemo)embolization, radiofrequency ablation, percutaneous interventional therapy, is allowed but the treatment must be completed at least 4 weeks prior to the baseline scan.
Patients have adequate bone marrow reserves defined as:
- ANC ≧ 1,500/μl;
- Platelets count ≧ 75,000/μl;
- Hemoglobin ≧ 8.5 g/dl.
Adequate liver and renal functions defined as:
- Child-Turcotte-Pugh score of 7 or lower (class A and well-compensated class B);
- Liver transaminase (ALT) ≦ 5 x upper limit of normal (ULN);
- Serum total bilirubin ≦ 3mg/dl;
- Serum albumin ≧ 2.8 g/dl;
- Prothrombin time (PT)-internal normalized ration (INR) ≦ 2.3 or partial thrombin time (PTT) ≦ 6 seconds above control;
- Serum creatinine ≦ 1.5 x ULN.
- Women of childbearing potential and men must agree to use adequate contraception, prior to study entry, during treatment, and at least 3 months after last dose of treatment.
- Patients must understand the protocol and sign a written informed consent.
Exclusion Criteria:
- Previous use of systemic anti-cancer therapy for HCC such as chemotherapy, immunotherapy, and targeting therapy within 4 weeks to study entry.
- Patients with prior use of investigational drugs including sorafenib and thalidomide.
- Active cardiac disease, including CHF NYHA class > 2, active CAD, cardiac arrhythmias requiring anti-arrhythmic therapy other than beta-blockers or digoxin, and uncontrolled hypertension.
- Patients with hemorrhagic diathesis or have history of active bleeding with 30 days prior to study entry.
- History of HIV infection.
- Active or uncontrolled infections requiring antibiotics treatment.
- Metastatic brain or leptomeningeal tumours unless the patients is > 6 months from definitive therapy, has negative imaging study within 4 weeks of study entry, and is clinically stable with respect to the tumour at the time of study entry.
- With seizure disorder requiring medication (such as steroids or anti-epileptics).
- History of organ allograft.
- Undergoing renal dialysis.
- Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, superficial bluffer tumours [Ta, Tis & T1] or any cancer curatively treated > 3 years prior to study entry.
- Pregnant or breast-feeding patients.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 단일 그룹 할당
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Phase I Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and Escalation dose of Thalidomide at dose Level I: 50 mg/day (50mg, p.o., qd); Level II: 100 mg/day (50mg, p.o., bid); Level III: 150 mg/day (100mg/50mg, p.o., bid); Level IV: 200 mg/day (100mg, p.o., bid). Phase II Fixed dose of Sorafenib 800mg/day (400mg, p.o., bid); and MTD of Thalidomide at phase I study.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Terms of efficacy assessment: objective tumor response, overall survival, progression-free survival. Terms of safety assessment: adverse effects, laboratory values.
기간: The overall survival will be measured from the time the patient has started protocol treatment to the date of the patient's death. 2. An interim analysis of safety profiles will be reviewed by safety committee.
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The overall survival will be measured from the time the patient has started protocol treatment to the date of the patient's death. 2. An interim analysis of safety profiles will be reviewed by safety committee.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Chung Hu Chan, MD, PHD, National Health Research Institutes, Taiwan
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 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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H. Lee Moffitt Cancer Center and Research Institute종료됨
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Exelixis모집하지 않고 적극적으로간세포 암미국, 아르헨티나, 호주, 오스트리아, 벨기에, 브라질, 캐나다, 중국, 콜롬비아, 체코, 프랑스, 그루지야, 독일, 홍콩, 헝가리, 아일랜드, 이스라엘, 이탈리아, 대한민국, 멕시코, 네덜란드, 뉴질랜드, 필리핀 제도, 폴란드, 루마니아, 러시아 연방, 싱가포르, 스페인, 스위스, 대만, 태국, 칠면조, 우크라이나, 영국
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