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

NCT01406574 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2015-06-08

Study results available
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Summary

The purpose of this study is:

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

Conditions

Interventions

DRUG

OPB-31121

Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)

DRUG

OPB-31121 phase2

Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
20 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • Japan

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01406574 on ClinicalTrials.gov