Clinical trial · Interventional
Resminostat (YHI-1001) in Combination With Sorafenib in Asian Patients With Advanced Hepatocellular Carcinoma (HCC)
A Phase I/II Study in Combination of Resminostat and Sorafenib in Patients With Advanced Hepatocellular Carcinoma Previously Untreated With Systemic Chemotherapy
NCT02400788CI-TRIAL-00031186completedPhase 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)
The purpose of this study is to assess efficacy and safety in combination of resminostat and sorafenib in Asian patients with advanced HCC previously untreated with systemic chemotherapy.
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 |
|---|---|---|---|
| Resminostat | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Resminostat + Sorafenib
- description
- oral administration
- interventionNames
- Drug: Resminostat
- Drug: Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- oral administration
- interventionNames
- Drug: Sorafenib
Primary outcomes (2)
- measure
- Phase 1 : Number of participants with dose limited toxicities as measure of safety and tolerability
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Main Inclusion Criteria: * Patients with advanced or metastatic hepatocellular carcinoma * Patients with ECOG PS of 0-1 * Patients who can be treated with oral medications and have no gastrointestinal function disorder which is considered to affect the absorption of medications Main Exclusion Criteria: * Patients with a history of treatment with HDAC inhibitors * Pregnant women and lactating mothers * Patients with brain metastases or suspected brain metastases based on the clinical symptoms
References
Publications (0)
Data not yet available
No reference posted for this study.