Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
NCT ID: NCT01406574
Last Updated: 2015-06-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
23 participants
INTERVENTIONAL
2011-07-31
2014-03-31
Brief Summary
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Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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OPB-31121 p1
Phase1 step
OPB-31121
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
OPB-31121 p2
Phase2 step
OPB-31121 phase2
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
Interventions
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OPB-31121
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
OPB-31121 phase2
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
Eligibility Criteria
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Inclusion Criteria
* 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 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
20 Years
79 Years
ALL
No
Sponsors
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Otsuka Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Chiba, , Japan
Tokyo, , Japan
Countries
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Other Identifiers
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JapicCTI-111546
Identifier Type: OTHER
Identifier Source: secondary_id
252-11-001
Identifier Type: -
Identifier Source: org_study_id
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