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

May 21, 2015 updated by: Otsuka Pharmaceutical Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
      • Tokyo, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
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.
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)
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
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
Time Frame: 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.
From first dose of study medication up to 28 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 252-11-001
  • JapicCTI-111546 (OTHER: JAPIC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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