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

This study has been completed.
Sponsor:
Information provided by:
Zeria Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00731445
First received: August 8, 2008
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Phase I : Determine the pharmacokinetics of this drug in these patients [ Time Frame: 28 days for 6 courses ] [ Designated as safety issue: Yes ]
  • Phase I : Determine the adverse effects profile of this drug in these patients [ Time Frame: 28 days for 6 courses ] [ Designated as safety issue: Yes ]
  • Phase II: Determine the PFS [ Time Frame: 28 days for 6 courses ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731445

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

No publications provided

Responsible Party: Zeria Pharmaceutical Co., Ltd
ClinicalTrials.gov Identifier: NCT00731445     History of Changes
Other Study ID Numbers: 07010101
Study First Received: August 8, 2008
Last Updated: June 29, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Zeria Pharmaceutical:
Z-208

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Carcinoma
Adenocarcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on October 19, 2014