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

Sponsored by:	Zeria Pharmaceutical
Information provided by:	Zeria Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00731445

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 I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ] [ 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
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

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

Contacts

Contact: Fumihiko Kanai, PhD, MD

0356447050

Locations

Japan
The University of Tokyo Hospital	Recruiting
Tokyo, Japan
Contact: Shuichiro Shiina, PhD, MD
Principal Investigator: Shuichiro Shiina, PhD, MD

Sponsors and Collaborators

Zeria Pharmaceutical

Investigators

Study Chair:

Masao Omata, PhD, MD

The University of Tokyo

More Information

Responsible Party:	Zeria Pharmaceutical Co., Ltd
Study ID Numbers:	07010101
Study First Received:	August 8, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00731445
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Zeria Pharmaceutical:

Z-208

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms

Gastrointestinal Neoplasms
Adenocarcinoma
Hepatocellular carcinoma
Neoplasms, Glandular and Epithelial
Carcinoma

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009