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

The purpose of this study is:

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

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: OPB-31121; Drug: OPB-31121 phase2

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Japan
  • Chiba, Japan
  • Tokyo, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: FACTORIAL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: OPB-31121 p1; Phase1 step	Drug: OPB-31121; Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
EXPERIMENTAL: OPB-31121 p2; Phase2 step	Drug: OPB-31121 phase2; Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (ACTUAL): March 1, 2014
• Study Completion (ACTUAL): March 1, 2014

Study Registration Dates

• First Submitted: July 28, 2011
• First Submitted That Met QC Criteria: July 29, 2011
• First Posted (ESTIMATE): August 1, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): June 8, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Hepatocellular carcinoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 252-11-001; JapicCTI-111546 (OTHER: JAPIC)