Clinical trial NCT01942083: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Hepatocellular Carcinoma
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-09-13
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation study
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Safety of OPB-111077
timeFrame: Within the first cycle [24 days]
measure: To investigate the maximum tolerated dose (MTD) of OPB-111077
timeFrame: Within the first cycle [24 days]
Secondary outcomes:
measure: Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.
timeFrame: Within the first cycle [24 days]
measure: Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1
timeFrame: Approximately 3-18 weeks depending on tumor response
measure: Biomarker of OPB-111077
timeFrame: Within the first cycle [24 days]
Other outcomes:
Locations:
city: Seoul & Gyeonggi-Do
country: Korea, Republic of
Study officials:
References: