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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is:

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Criteria

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