At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 23 enrolled
Drug / intervention
OPB-31121 +1 moredrug
Likely dose
OPB-31121 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating OPB-31121 and OPB-31121 phase2 for Hepatocellular Carcinoma. Completed, enrolled 23 participants across 2 sites.
Detailed Summary
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatocellular Carcinoma
CountriesJapan
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJul 2011
First PostedAug 2011
Primary CompletionMar 2014
TodayJul 2026
First PostedAug 1, 2011
Enrollment StartJul 1, 2011
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.9 years ago
Interventions
OPB-31121drug
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
OPB-31121 phase2drug
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)