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

June 29, 2012 updated by: Zeria Pharmaceutical

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

This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma

Study Overview

Status

Completed

Conditions

Advanced Hepatocellular Carcinoma

Intervention / Treatment

Drug: Z-208

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.

Study Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Japan
- - Tokyo, Japan
    - The University of Tokyo Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma Time Frame: 28 days	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	28 days for 6 courses

Secondary Outcome Measures

Outcome Measure	Time Frame
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	28 days for 6 courses
Phase I : Determine the pharmacokinetics of this drug in these patients Time Frame: 28 days for 6 courses	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	28 days for 6 courses
Phase II: Determine the PFS Time Frame: 28 days for 6 courses	28 days for 6 courses

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zeria Pharmaceutical

Investigators

Study Chair: Masao Omata, PhD, MD, Tokyo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

August 8, 2008

First Submitted That Met QC Criteria