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)

Advanced Hepatocellular Carcinoma Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01942083
• Other study ID #: 317-12-001
• Secondary ID: There is no seco
• Status: Terminated
• Phase: Phase 1
• First received: June 26, 2013
• Last updated: May 7, 2017
• Start date: May 29, 2013
• Est. completion date: July 11, 2016

Study information

• Verified date: May 2017
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: July 11, 2016
• Est. primary completion date: June 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• OPB-111077

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of OPB-111077	Number of participants with adverse events as assessed by CTCAE v4.0	Within the first cycle [24 days]
Primary	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.	Within the first cycle [24 days]
Secondary	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.	Within the first cycle [24 days]
Secondary	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.	Approximately 3-18 weeks depending on tumor response
Secondary	Biomarker of OPB-111077	Change from baseline on predictable biomarker specified in the protocol	Within the first cycle [24 days]