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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


Phase 1/Phase 2
20 Years
79 Years
Open (Enrolling)
Both
Hepatocellular Carcinoma

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Phase1: safety

Outcome Description:

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 Time Frame:

1 month

Safety Issue:

Yes

Authority:

Japan: Ministry of Health, Labor and Welfare

Study ID:

252-11-001

NCT ID:

NCT01406574

Start Date:

July 2011

Completion Date:

February 2014

Related Keywords:

  • Hepatocellular Carcinoma
  • Hepatocellular carcinoma
  • Carcinoma
  • Carcinoma, Hepatocellular

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