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

Zeria Pharmaceutical

Status and phase

Completed

Phase 2

Phase 1

Conditions

Advanced Hepatocellular Carcinoma

Treatments

Drug: Z-208

Study type

Interventional

Funder types

Industry

Identifiers

NCT00731445

07010101

Details and patient eligibility

About

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

Full 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.

Enrollment

43 estimated patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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