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)

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01942083

Enrollment

Registered

2013-09-13

Start date

2013-05-29

Completion date

2016-07-11

Last updated

2017-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Hepatocellular Carcinoma

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.

Interventions

DRUGOPB-111077

Study design

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Dose escalation study

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Safety of OPB-111077	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	Within the first cycle [24 days]	• The highest dose that does not lead to discontinuation of dose escalation is defined as the MTD.

Secondary

Measure	Time frame	Description
Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.	Within the first cycle [24 days]	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.
Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1	Approximately 3-18 weeks depending on tumor response	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.
Biomarker of OPB-111077	Within the first cycle [24 days]	Change from baseline on predictable biomarker specified in the protocol

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026