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

Primary Purpose

Advanced Hepatocellular Carcinoma

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Z-208

About this trial

This is an interventional treatment trial for Advanced Hepatocellular Carcinoma focused on measuring Z-208

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Tokyo Hospital

Outcomes

Primary Outcome Measures

Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma

Phase II : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Secondary Outcome Measures

Phase I : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Phase I : Determine the pharmacokinetics of this drug in these patients

Phase I : Determine the adverse effects profile of this drug in these patients

Phase II: Determine the PFS

Full Information

NCT ID

NCT00731445

First Posted

August 8, 2008

Last Updated

June 29, 2012

Sponsor

Zeria Pharmaceutical

1. Study Identification

Unique Protocol Identification Number

NCT00731445

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Zeria Pharmaceutical

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Hepatocellular Carcinoma

Keywords

Z-208

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

43 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Z-208

Intervention Description

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

Primary Outcome Measure Information:

Title

Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma

Time Frame

28 days

Title

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 Measure Information:

Title

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

Title

Phase I : Determine the pharmacokinetics of this drug in these patients

Time Frame

28 days for 6 courses

Title

Phase I : Determine the adverse effects profile of this drug in these patients

Time Frame

28 days for 6 courses

Title

Phase II: Determine the PFS

Time Frame

28 days for 6 courses

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Masao Omata, PhD, MD

Organizational Affiliation

Tokyo University

Official's Role

Study Chair

Facility Information:

Facility Name

The University of Tokyo Hospital

City

Tokyo

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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