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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zeria Pharmaceutical

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