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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00731445

Enrollment

Registered

2008-08-11

Start date

2008-07-31

Completion date

2012-06-30

Last updated

2012-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Z-208

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.

Interventions

DRUGZ-208

Oral pills taken daily; 8mg, 12mg, 16mg, 4mg

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026