Status:
COMPLETED
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
20-79 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01406574
Start Date
July 1 2011
End Date
March 1 2014
Last Update
June 8 2015
Active Locations (2)
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1
Chiba, Japan
2
Tokyo, Japan