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

Otsuka

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Drug: OPB-31121; Drug: OPB-31121 phase2

Study type: Interventional

Funder types: Industry

Identifiers

NCT01406574

JapicCTI-111546 (Other Identifier)

252-11-001

Details and patient eligibility

About

The purpose of this study is:

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

Enrollment: 23 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

OPB-31121 p1

Experimental group

Description:

Phase1 step

Treatment:

Drug: OPB-31121

OPB-31121 p2

Experimental group

Description:

Phase2 step

Treatment:

Drug: OPB-31121 phase2