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

This study has been completed.
Information provided by:
Zeria Pharmaceutical Identifier:
First received: August 8, 2008
Last updated: June 29, 2012
Last verified: June 2012
This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma

Condition Intervention Phase
Advanced Hepatocellular Carcinoma
Drug: Z-208
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral Z-208 in Patients With Advanced Hepatocellular Carcinoma

Further study details as provided by Zeria Pharmaceutical:

Primary Outcome Measures:
  • Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma [ Time Frame: 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 ]

Secondary Outcome Measures:
  • 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 ]
  • Phase I : Determine the pharmacokinetics of this drug in these patients [ Time Frame: 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 ]
  • Phase II: Determine the PFS [ Time Frame: 28 days for 6 courses ]

Estimated Enrollment: 43
Study Start Date: July 2008
Study Completion Date: June 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Z-208
    Oral pills taken daily; 8mg, 12mg, 16mg, 4mg
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.


Ages Eligible for Study:   20 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00731445

The University of Tokyo Hospital
Tokyo, Japan
Sponsors and Collaborators
Zeria Pharmaceutical
Study Chair: Masao Omata, PhD, MD Tokyo University
  More Information

Responsible Party: Zeria Pharmaceutical Co., Ltd Identifier: NCT00731445     History of Changes
Other Study ID Numbers: 07010101
Study First Received: August 8, 2008
Last Updated: June 29, 2012

Keywords provided by Zeria Pharmaceutical:

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on April 28, 2017