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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01406574
Recruitment Status : Completed
First Posted : August 1, 2011
Results First Posted : June 8, 2015
Last Update Posted : June 8, 2015
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:

The purpose of this study is:

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: OPB-31121 Drug: OPB-31121 phase2 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Subjects With Treatment Emergent Adverse Events [ Time Frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) ]
    Treatment emergent adverse events observed during outcome measure time frame.

  2. Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs) [ Time Frame: From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32) ]

    Recommended Dose (RD) of OPB-31121 was defined as the highest dose at which Dose Limited Toxicity (DLT) occurred at an incidence of < 30%.

    DLT was defined as adverse events related to OPB-31121 occurring until Day 32, and 1) Grade 4 neutrophil count decreased persisting for ≧ 8 days, or Grade 3 or 4 febrile neutropenia, or infection with neutrophil count decreased 2) Grade 4 Plt decreased, or Grade 3 Plt decreased persisting for ≧ 8 days 3) Grade 3 or 4 nausea, vomiting, or diarrhoea that occurred despite the use of an anti-emetic or anti-diarrheal agents 4) Grade 3 or more severe AEsa excluding the AEs presented above 1) to 3) 5) AEs requiring interruption of IMP administration for a period of ≧ 8 consecutive days 6) Same AEs causing interruption of IMP administration twice

Secondary Outcome Measures :
  1. Best Overall Response [ Time Frame: From first dose of study medication up to 28 weeks ]
    Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01406574

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Chiba, Japan
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
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Responsible Party: Otsuka Pharmaceutical Co., Ltd. Identifier: NCT01406574    
Other Study ID Numbers: 252-11-001
JapicCTI-111546 ( Other Identifier: JAPIC )
First Posted: August 1, 2011    Key Record Dates
Results First Posted: June 8, 2015
Last Update Posted: June 8, 2015
Last Verified: May 2015
Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Hepatocellular carcinoma
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases