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

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
OPB-31121
OPB-31121 phase2
Sponsored by
Otsuka Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular carcinoma

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

OPB-31121 p1

OPB-31121 p2

Arm Description

Phase1 step

Phase2 step

Outcomes

Primary Outcome Measures

Subjects With Treatment Emergent Adverse Events
Treatment emergent adverse events observed during outcome measure time frame.
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
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

Best Overall Response
Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.

Full Information

First Posted
July 28, 2011
Last Updated
May 21, 2015
Sponsor
Otsuka Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01406574
Brief Title
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is: Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OPB-31121 p1
Arm Type
Experimental
Arm Description
Phase1 step
Arm Title
OPB-31121 p2
Arm Type
Experimental
Arm Description
Phase2 step
Intervention Type
Drug
Intervention Name(s)
OPB-31121
Intervention Description
Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
Intervention Type
Drug
Intervention Name(s)
OPB-31121 phase2
Intervention Description
Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
Primary Outcome Measure Information:
Title
Subjects With Treatment Emergent Adverse Events
Description
Treatment emergent adverse events observed during outcome measure time frame.
Time Frame
From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Title
Number of Participants Who Experienced Dose-Limiting Toxicities (DLTs)
Description
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
Time Frame
From first study medication to on Day 32 (after repeated 28 days medication from Day 4 to 32)
Secondary Outcome Measure Information:
Title
Best Overall Response
Description
Overall response was evaluated based on the Response Evaluation Criteria in Solid Tumors (RECIST guideline) - mRECIST 1.0.
Time Frame
From first dose of study medication up to 28 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Chiba
Country
Japan
City
Tokyo
Country
Japan

12. IPD Sharing Statement

Learn more about this trial

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

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