Clinical trial · Interventional
A Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB(Otsuka Pharmaceutical Biwa)-111077 in Subjects With Advanced HCC(Hepatocellular Carcinoma)
NCT01942083CI-TRIAL-00027468terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Company decision
Summary
Brief summary (as posted)
This is a Phase I, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in subjects with advanced HCC.
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 |
|---|---|---|---|
| OPB-111077 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- OPB-111077
- description
- orally, once daily
- interventionNames
- Drug: OPB-111077
Primary outcomes (2)
- measure
- Safety of OPB-111077
- timeFrame
- Within the first cycle [24 days]
- description
- Number of participants with adverse events as assessed by CTCAE v4.0
- measure
- To investigate the maximum tolerated dose (MTD) of OPB-111077
- timeFrame
- Within the first cycle [24 days]
- description
- • The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines. 2. Subject who has advanced HCC 3. Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment 4. Male or female subject, age at consent ≥20 years and ≤75 years. 5. Life expectancy ≥12 weeks. 6. Subjects who agree that they or their partner(s) will practice contraception during the study period and 3 months (12 weeks) after the completion of study treatment. 7. Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the Investigator using the written consent form, and give written consent to participate in the study of their own free will. Exclusion Criteria: 1. Past liver transplantation 2. Uncontrollable hepatic encephalopathy or ascites 3. Presence of brain metastases 4. Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding. 5. Primary malignancy other than HCC 6. Human immunodeficiency virus (HIV) infection 7. Severe or poorly controlled complication that may affect the conduct or results of the study. 8. Use of Interferon preparation within 4 weeks (28 days) before start of study treatment in the present study. 9. Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period 10. Other cases judged by the Investigator to be ineligible for participation in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.