Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

Phase 1

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: OPB-31121 phase2; Drug: OPB-31121

• Registration Number: NCT01406574
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

The purpose of this study is:

Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-28
• Study First Submitted QC: 2011-07-29
• Study First Posted: 2011-08-01
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Results First Submitted: 2015-04-14
• Status Verified: 2015-05
• Results First Submitted QC: 2015-05-21
• Last Update Submitted: 2015-05-21
• Results First Posted: 2015-06-08
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
OPB-31121 p2	OPB-31121 phase2	Phase2 step
OPB-31121 p1	OPB-31121	Phase1 step

Primary Outcome Measures

Name	Time	Method
Subjects With Treatment Emergent Adverse Events	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)	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 Outcome Measures

Name	Time	Method
Best Overall Response	From first dose of study medication up to 28 weeks	Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.