A Phase 1/2 interventional study of Z-208 in Advanced Hepatocellular Carcinoma, sponsored by Zeria Pharmaceutical. Completed at 1 site in Japan. Open to participants aged 20 Years to 79 Years. Per ClinicalTrials.gov, last updated 2012-07-03.
Sponsored by Zeria Pharmaceutical · Phase 1/2, Interventional, and Treatment
This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma
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.
Zeria Pharmaceutical is the lead sponsor of 23 studies on the registry; none are open to participants now.
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Exclusion criteria
Oral pills taken daily; 8mg, 12mg, 16mg, 4mg
Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma
Time frame: 28 days
Phase II : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time frame: 28 days for 6 courses
Phase I : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
Time frame: 28 days for 6 courses
Phase I : Determine the pharmacokinetics of this drug in these patients
Time frame: 28 days for 6 courses
Phase I : Determine the adverse effects profile of this drug in these patients
Time frame: 28 days for 6 courses
Phase II: Determine the PFS
Time frame: 28 days for 6 courses
The record gives a start of Jul 2008, a primary completion of Jan 2012 and a completion of Jun 2012. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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