Clinical trial · Interventional
Phase I/II Study of Z-208 in Advanced Hepatocellular Carcinoma (HCC)
Phase I/II Dose Escalation, Pharmacokinetic, Safety, and Efficacy Study of Oral Z-208 in Patients With Advanced Hepatocellular Carcinoma
NCT00731445CI-TRIAL-00007338completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase I/II is studying the side effect and best dose of Z-208 for patients with advanced hepatocellular carcinoma
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Z-208 | Drug | Tamibarotene | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Phase I: Determine the maximum tolerated dose (MTD) of Z-208 in patients with advanced hepatocellular carcinoma
- timeFrame
- 28 days
- measure
- Phase II : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- timeFrame
- 28 days for 6 courses
Secondary outcomes (4)
- measure
- Phase I : Assess the objective tumor response rate in patients according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- timeFrame
- 28 days for 6 courses
- measure
- Phase I : Determine the pharmacokinetics of this drug in these patients
- timeFrame
- 28 days for 6 courses
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.