Status:
COMPLETED
Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Zeria Pharmaceutical
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
20-79 years
Phase:
PHASE1
PHASE2
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 t...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2012
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00731445
Start Date
July 1 2008
End Date
June 1 2012
Last Update
July 3 2012
Active Locations (1)
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1
The University of Tokyo Hospital
Tokyo, Japan