Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral Z-208 in Patients With Advanced Hepatocellular Carcinoma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma
研究概览
简要总结
This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma
详细描述
This is an open-label, dose-escalation study PhaseI Treatments repeats for 28 days for 1 course in the unacceptable toxicity
Cohort of 3 patients receive escalating doses of Z-208 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 1 of 3 patients experience dose-limiting toxicity.
PhaseII Treatments repeats for 28 days for 6 courses until absence of disease progression or unacceptable toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed hepatocellular carcinoma
- •At least one measurable site of disease according to RECIST criteria that has not been irradiated.
- •Child-Pugh classification A & B
- •ECOG performance status of 0-1
- •Life expectancy is more than 90 days
- •Adequate organ function as defined by the following criteria, Hemoglobin ≥ 8.0 g/dL WBC ≥ 3,000/mm^3 <12,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 50,000/mm^3 AST and ALT ≤ 5 times upper limit of normal (ULN) Albumin ≥ 2.8 g/dL Bilirubin ≤ 2.0 mg/dL Creatinine ≤ 1.5 times ULN
- •Must provide written informed consent prior to the implementation of any study assessment or procedures
排除标准
- •Patients received treatment with any of the following within the specified timeframe;Any surgical procedure, radiofrequency ablation, intraarterial chemotherapy within 30 days prior to signing the ICF, any treatment with transfusion, albumin preparation, G-CSF within 15 days prior to signing the ICF
- •CNS involvement must have completed appropriate treatment
- •Prior deep vein thrombosis
- •Has ascites, pleural effusions or pericardial fluid refractory
- •Active clinically serious infection excluding chronic hepatitis
- •Any history of deep vein thrombosis, pulmonary embolism, myocardial infraction, cerebrovascular accident
- •Allergy or hypersensitivity to Vitamin A
- •Women who are pregnant or breast feeding
结局指标
主要结局
Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma
时间窗: 28 days
Phase II : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
时间窗: 28 days for 6 courses
次要结局
- Phase I : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria(28 days for 6 courses)
- Phase I : Determine the pharmacokinetics of this drug in these patients(28 days for 6 courses)
- Phase I : Determine the adverse effects profile of this drug in these patients(28 days for 6 courses)
- Phase II: Determine the PFS(28 days for 6 courses)