Back to resultsA Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB(Otsuka Pharmaceutical Biwa)-111077 in Subjects With Advanced HCC(Hepatocellular Carcinoma)
Primary Purpose
Advanced Hepatocellular Carcinoma
Status
Terminated
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
OPB-111077
Sponsored by
About this trial
This is an interventional treatment trial for Advanced Hepatocellular Carcinoma
Eligibility Criteria
Inclusion Criteria:
- Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines.
- Subject who has advanced HCC
- Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment
- Male or female subject, age at consent ≥20 years and ≤75 years.
- Life expectancy ≥12 weeks.
- Subjects who agree that they or their partner(s) will practice contraception during the study period and 3 months (12 weeks) after the completion of study treatment.
- Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the Investigator using the written consent form, and give written consent to participate in the study of their own free will.
Exclusion Criteria:
- Past liver transplantation
- Uncontrollable hepatic encephalopathy or ascites
- Presence of brain metastases
- Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding.
- Primary malignancy other than HCC
- Human immunodeficiency virus (HIV) infection
- Severe or poorly controlled complication that may affect the conduct or results of the study.
- Use of Interferon preparation within 4 weeks (28 days) before start of study treatment in the present study.
- Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period
- Other cases judged by the Investigator to be ineligible for participation in the study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPB-111077
Arm Description
orally, once daily
Outcomes
Primary Outcome Measures
Safety of OPB-111077
Number of participants with adverse events as assessed by CTCAE v4.0
To investigate the maximum tolerated dose (MTD) of OPB-111077
• The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.
Secondary Outcome Measures
Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1
Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the Early Termination (discontinuation) Visit.
Biomarker of OPB-111077
Change from baseline on predictable biomarker specified in the protocol
Full Information
NCT ID
NCT01942083
First Posted
June 26, 2013
Last Updated
May 7, 2017
Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01942083
Brief Title
A Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB(Otsuka Pharmaceutical Biwa)-111077 in Subjects With Advanced HCC(Hepatocellular Carcinoma)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Company decision
Study Start Date
May 29, 2013 (Actual)
Primary Completion Date
June 1, 2016 (Actual)
Study Completion Date
July 11, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a Phase I, open label, non randomized, multicenter study designed to investigate the safety and tolerability of escalating doses of OPB-111077 administered orally, once daily in subjects with advanced HCC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Hepatocellular Carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation study
Masking
None (Open Label)
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPB-111077
Arm Type
Experimental
Arm Description
orally, once daily
Intervention Type
Drug
Intervention Name(s)
OPB-111077
Primary Outcome Measure Information:
Title
Safety of OPB-111077
Description
Number of participants with adverse events as assessed by CTCAE v4.0
Time Frame
Within the first cycle [24 days]
Title
To investigate the maximum tolerated dose (MTD) of OPB-111077
Description
• The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.
Time Frame
Within the first cycle [24 days]
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
Description
The following PK parameters (Cmax (maximum observed concentration), AUC(area uder the concentration time curve from zero), tmax (Time to maximum plasma concentration), etc.) will be determined using a non-compartmental methods.
Time Frame
Within the first cycle [24 days]
Title
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1
Description
Assessment will be conducted at Screening, end of Cycle 1, end of Cycle 2, end of every 2 cycles thereafter, at the Early Termination (discontinuation) Visit.
Time Frame
Approximately 3-18 weeks depending on tumor response
Title
Biomarker of OPB-111077
Description
Change from baseline on predictable biomarker specified in the protocol
Time Frame
Within the first cycle [24 days]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines.
Subject who has advanced HCC
Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment
Male or female subject, age at consent ≥20 years and ≤75 years.
Life expectancy ≥12 weeks.
Subjects who agree that they or their partner(s) will practice contraception during the study period and 3 months (12 weeks) after the completion of study treatment.
Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the Investigator using the written consent form, and give written consent to participate in the study of their own free will.
Exclusion Criteria:
Past liver transplantation
Uncontrollable hepatic encephalopathy or ascites
Presence of brain metastases
Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding.
Primary malignancy other than HCC
Human immunodeficiency virus (HIV) infection
Severe or poorly controlled complication that may affect the conduct or results of the study.
Use of Interferon preparation within 4 weeks (28 days) before start of study treatment in the present study.
Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period
Other cases judged by the Investigator to be ineligible for participation in the study.
Facility Information:
City
Seoul & Gyeonggi-Do
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
A Phase I, Open Label, Non Randomized, Multicenter, Dose Escalation Clinical Study to Investigate Safety and Tolerability of OPB(Otsuka Pharmaceutical Biwa)-111077 in Subjects With Advanced HCC(Hepatocellular Carcinoma)
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