Clinical trial · Interventional
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
A Multicenter, Open-label, Non-randomized, Dose-escalation, Therapeutic Exploratory Trial to Evaluate the Safety and Efficacy of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
NCT01406574CI-TRIAL-00018208completedPhase 1 / Phase 2Results postedClinicalTrials.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)
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OPB-31121 | Drug | — | UNRESOLVED |
| OPB-31121 phase2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- OPB-31121 p1
- description
- Phase1 step
- interventionNames
- Drug: OPB-31121
- type
- EXPERIMENTAL
- label
- OPB-31121 p2
- description
- Phase2 step
- interventionNames
- Drug: OPB-31121 phase2
Primary outcomes (2)
- measure
- Subjects With Treatment Emergent Adverse Events
- timeFrame
- From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 79 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma * Patients with Child-Pugh classification A or B * Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy * Patients who are able to take oral medication * Patients age 20 to 79 years (inclusive) at time of informed consent * Patients with an ECOG performance status score of 0-2 * Patients have the eligible organ function. Exclusion Criteria: * Patients with a primary malignant tumor * Patients with a history of liver transplant * Patients with brain metastases * Patients with a complication of uncontrolled * Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial
References
Publications (0)
Data not yet available
No reference posted for this study.