JPRN-jRCT2080221507
Unknown
Phase 1
A multicenter, open-label, non-randomized, dose-escalation, therapeutic exploratory trial to evaluate the safety and efficacy of OPB-31121 in patients with progressive hepatocellular carcinoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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