Trials / Completed
CompletedNCT01406574
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Otsuka Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 79 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | OPB-31121 | Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month) |
| DRUG | OPB-31121 phase2 | Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months) |
Timeline
- Start date
- 2011-07-01
- Primary completion
- 2014-03-01
- Completion
- 2014-03-01
- First posted
- 2011-08-01
- Last updated
- 2015-06-08
- Results posted
- 2015-06-08
Locations
2 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT01406574. Inclusion in this directory is not an endorsement.