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

NCT00731445 | Completed Phase 1 DMC

• 1 other identifier: 07010101
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Advanced Hepatocellular Carcinoma

Keywords

Z-208

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Interventions

Z-208 DRUG

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

Eligibility Criteria

• Age: 20 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zeria Pharmaceutical: lead

Study Sites (1)

The University of Tokyo Hospital

Tokyo, Japan

Location

Study Officials

• Masao Omata, PhD, MD

  Tokyo University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 8, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2008
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 3, 2012

Record last verified: 2012-06

Locations

JP (1)