Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)
Phase 1
Completed
- Conditions
- Advanced Hepatocellular Carcinoma
- Registration Number
- NCT00731445
- Lead Sponsor
- Zeria Pharmaceutical
- Brief Summary
This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma 28 days Phase II : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 28 days for 6 courses
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The University of Tokyo Hospital
🇯🇵Tokyo, Japan