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)

NCT01942083 | Terminated Phase 1

• 2 other identifiers: 317-12-001There is no secondary ID.
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Safety of OPB-111077

  Number of participants with adverse events as assessed by CTCAE v4.0

  Within the first cycle [24 days]

• 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 Outcomes (3)

• Pharmacokinetics (PK) properties of OPB-111077 and its metabolites.

  Within the first cycle [24 days]

• Tumor response measured by RECIST(Response Evaluation Criteria in Solid Tumor) 1.1

  Approximately 3-18 weeks depending on tumor response

• Biomarker of OPB-111077

  Within the first cycle [24 days]

Study Arms (1)

OPB-111077

EXPERIMENTAL

orally, once daily

Drug: OPB-111077

Interventions

OPB-111077 DRUG

OPB-111077

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histopathologically or clinically diagnosed HCC by Korean Liver Cancer Study Group (KLCSG) guidelines.
• Subject who has advanced HCC
• Documented evidence of unresponsiveness to, intolerance to, or ineligibility for sorafenib, or unavailability of appropriate sorafenib treatment
• Male or female subject, age at consent ≥20 years and ≤75 years.
• Life expectancy ≥12 weeks.
• 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.
• 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.

You may not qualify if:

• Past liver transplantation
• Uncontrollable hepatic encephalopathy or ascites
• Presence of brain metastases
• Clinically significant gastrointestinal bleeding in past 6 months or current active gastrointestinal bleeding.
• Primary malignancy other than HCC
• Human immunodeficiency virus (HIV) infection
• Severe or poorly controlled complication that may affect the conduct or results of the study.
• Use of Interferon preparation within 4 weeks (28 days) before start of study treatment in the present study.
• Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period
• Other cases judged by the Investigator to be ineligible for participation in the study.

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Seoul & Gyeonggi-Do, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation study

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: September 13, 2013
• Study Start: May 29, 2013
• Primary Completion: June 1, 2016
• Study Completion: July 11, 2016
• Last Updated: May 9, 2017

Record last verified: 2017-05

Locations

KR (1)