This clinical study is to test the safety (the impact of the study drug named OPB-111077 on your body) and tolerability.
- Conditions
- Neoplasms
- Registration Number
- KCT0001016
- Lead Sponsor
- Korea Otsuka Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 48
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 or Sub-investigator using the written consent form, and give written consent to participate in the study of their own free will.
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 or Subinvestigator to be ineligible for participation in the study.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the safety, tolerability and maximum tolerated dose (MTD) of OPB 111077 administered orally once daily (QD) in subjects with advanced hepatocellular carcinoma (HCC).
- Secondary Outcome Measures
Name Time Method To investigate the pharmacokinetics (PK) properties of OPB 111077 and its metabolites in plasma after single and repeated administration of OPB-111077;Tumor response measured by RECIST 1.1 (Response Evaluation Criteria in Solid Tumor)