Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
The purpose of this study is:
Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
Drug: OPB-31121 phase2
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Subjects With Treatment Emergent Adverse Events [ Time Frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) ] [ Designated as safety issue: Yes ]Treatment emergent adverse events observed during outcome measure time frame.
- Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) ] [ Designated as safety issue: Yes ]
Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.
DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice
- Best Overall Response [ Time Frame: From first dose of study medication up to 28 weeks ] [ Designated as safety issue: No ]Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.
|Study Start Date:||July 2011|
|Study Completion Date:||March 2014|
|Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
Experimental: OPB-31121 p1
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
Experimental: OPB-31121 p2
Drug: OPB-31121 phase2
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406574