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)

Korea Otsuka Pharmaceutical Co., Ltd.0 sites33 target enrollmentMay 29, 2013

ConditionsAdvanced Hepatocellular Carcinoma

InterventionsOPB-111077

DrugsOPB-111077

Overview

Phase: Phase 1
Intervention: OPB-111077
Conditions: Advanced Hepatocellular Carcinoma
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Enrollment: 33
Primary Endpoint: Safety of OPB-111077
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 29, 2013

End Date

July 11, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

OPB-111077

orally, once daily

Intervention: OPB-111077

Outcomes

Primary Outcomes

Safety of OPB-111077

Time Frame: Within the first cycle [24 days]

Number of participants with adverse events as assessed by CTCAE v4.0

To investigate the maximum tolerated dose (MTD) of OPB-111077

Time Frame: Within the first cycle [24 days]

• The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.

Secondary Outcomes

Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.(Within the first cycle [24 days])
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1(Approximately 3-18 weeks depending on tumor response)
Biomarker of OPB-111077(Within the first cycle [24 days])