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
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 23
- Primary Endpoint
- Subjects With Treatment Emergent Adverse Events
Study Overview
Brief Summary
The purpose of this study is:
Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 79 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma
- •Patients with Child-Pugh classification A or B
- •Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy
- •Patients who are able to take oral medication
- •Patients age 20 to 79 years (inclusive) at time of informed consent
- •Patients with an ECOG performance status score of 0-2
- •Patients have the eligible organ function.
Exclusion Criteria
- •Patients with a primary malignant tumor
- •Patients with a history of liver transplant
- •Patients with brain metastases
- •Patients with a complication of uncontrolled
- •Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial
Arms & Interventions
OPB-31121 p1
Phase1 step
Intervention: OPB-31121 (Drug)
OPB-31121 p2
Phase2 step
Intervention: OPB-31121 phase2 (Drug)
Outcomes
Primary Outcomes
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)
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)
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
Secondary Outcomes
- Best Overall Response(From first dose of study medication up to 28 weeks)