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

This study is currently recruiting participants.
Verified May 2013 by Otsuka Pharmaceutical Co., Ltd.
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01406574
First received: July 28, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  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

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


Estimated Enrollment: 48
Study Start Date: July 2011
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01406574

Contacts
Contact: Drug Information Center +81-3-6361-7314

Locations
Japan
Recruiting
Chiba, Japan
Recruiting
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: May 14, 2013
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 May 19, 2013