NCT00731445

Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)

Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral Z-208 in Patients With Advanced Hepatocellular Carcinoma

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Zeria Pharmaceutical · Industry
• Sex: All
• Age: 20 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Z-208	Oral pills taken daily; 8mg, 12mg, 16mg, 4mg

Timeline

• Start date: 2008-07-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2008-08-11
• Last updated: 2012-07-03

Locations

1 site across 1 country: Japan