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
2 other identifiers
interventional
23
1 country
2
Brief Summary
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hepatocellular-carcinoma
Started Jul 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 28, 2011
CompletedFirst Posted
Study publicly available on registry
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2014
CompletedResults Posted
Study results publicly available
June 8, 2015
CompletedJune 8, 2015
May 1, 2015
2.7 years
July 28, 2011
April 14, 2015
May 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Subjects With Treatment Emergent Adverse Events
Treatment emergent adverse events observed during outcome measure time frame.
From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
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
From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Secondary Outcomes (1)
Best Overall Response
From first dose of study medication up to 28 weeks
Study Arms (2)
OPB-31121 p1
EXPERIMENTALPhase1 step
OPB-31121 p2
EXPERIMENTALPhase2 step
Interventions
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unknown Facility
Chiba, Japan
Unknown Facility
Tokyo, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Leader of Department of "Small Global" Clinical Development
- Organization
- Otsuka Pharmaceutical Co., Ltd
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2011
First Posted
August 1, 2011
Study Start
July 1, 2011
Primary Completion
March 1, 2014
Study Completion
March 1, 2014
Last Updated
June 8, 2015
Results First Posted
June 8, 2015
Record last verified: 2015-05