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)

NCT ID: NCT01942083

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-29
• Study Completion Date: 2016-07-11

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.

Conditions

Advanced Hepatocellular Carcinoma

Study Design

• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

OPB-111077

orally, once daily

Group Type: EXPERIMENTAL

OPB-111077

Intervention Type: DRUG

Interventions

OPB-111077

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines.

2. Subject who has advanced HCC

3. Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment

4. Male or female subject, age at consent ≥20 years and ≤75 years.

5. Life expectancy ≥12 weeks.

6. 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.

7. 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

1. Past liver transplantation

2. Uncontrollable hepatic encephalopathy or ascites

3. Presence of brain metastases

4. Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding.

5. Primary malignancy other than HCC

6. Human immunodeficiency virus (HIV) infection

7. Severe or poorly controlled complication that may affect the conduct or results of the study.

8. Use of Interferon preparation within 4 weeks (28 days) before start of study treatment in the present study.

9. Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period

10. Other cases judged by the Investigator to be ineligible for participation in the study.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Korea Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul & Gyeonggi-Do, , South Korea

Countries

South Korea

Other Identifiers

There is no secondary ID.

Identifier Type: -

Identifier Source: secondary_id

317-12-001

Identifier Type: -

Identifier Source: org_study_id