Progressive hepatocellular carcinoma
Conditions
Interventions
investigational material(s)
Generic name etc : OPB-31121
INN of investigational material :
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational materia
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase1: safety Adverse events, vital signs (blood pressure, pulse rate, and body temperature), body weight, clinical laboratory tests, 12-lead ECG, and ECOG Performance Status (PS) Phase2: efficacy Disease control rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase1: efficacy Overall response and tumor markers Phase2: safety Adverse events, vital signs (blood pressure, pulse rate, and body temperature), body weight, clinical laboratory tests, 12-lead ECG, and ECOG Performance Status (PS) | — |
Outcome results
None listed