Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral Z-208 in 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma
28 days
Yes
Masao Omata, PhD, MD
Study Chair
The University of Tokyo
Japan: Pharmaceuticals and Medical Devices Agency
07010101
NCT00731445
July 2008
June 2012
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