Phase I/II study of OPB-31121 in patients with progressive hepatocellular carcinoma
- Conditions
- Progressive hepatocellular carcinoma
- Registration Number
- JPRN-jRCT2080221507
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- Not specified
1) Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma
2) Patients with Child-Pugh classification A or B
3) Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy
4) Patients who are able to take oral medication
5) Patients age 20 to 79 years (inclusive) at time of informed consent
6) Patients with an ECOG performance status score of 0-2
7) Patients have the eligible organ function in screening visit
1) Patients with a primary malignant tumor
2) Patients with a history of liver transplant
3) Patients with brain metastases
4) Patients with a complication of uncontrolled
5) Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method