Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01406574
First received: July 28, 2011
Last updated: March 24, 2014
Last verified: March 2014
  Purpose

The purpose of this study is:

Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: OPB-31121
Drug: OPB-31121 phase2
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • Phase1: safety [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Disease control rate


Secondary Outcome Measures:
  • Phase1: efficacy [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Overall response and tumor markers

  • Phase2: safety [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Adverse events, vital signs (blood pressure, pulse rate, and body temperature), body weight, clinical laboratory tests, 12-lead ECG, and ECOG PS


Enrollment: 24
Study Start Date: July 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OPB-31121 p1
Phase1 step
Drug: OPB-31121
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
Experimental: OPB-31121 p2
Phase2 step
Drug: OPB-31121 phase2
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01406574

Locations
Japan
Chiba, Japan
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
  More Information

No publications provided

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01406574     History of Changes
Other Study ID Numbers: 252-11-001, JapicCTI-111546
Study First Received: July 28, 2011
Last Updated: March 24, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on July 20, 2014