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Completed

NCT Number: NCT01540461

Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)

The purpose of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of Brivanib in Chinese subjects with Advanced Hepatocellular Carcinoma (HCC).

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion criteria

Subjects with:

  • Confirmed Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
  • Not having received prior systemic treatment for advanced HCC
  • Normal or moderately impaired liver function (Child-Pugh Class A or B (CP total score of ≤ 7))
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion criteria

Subjects with:

  • Brain metastasis or evidence of leptomeningeal disease
  • History of impaired brain function (encephalopathy) or active heart disease
  • Unmanageable fluid in the abdomen (ascites)
  • Bleeding esophageal or gastric varices within 2 months prior to inclusion

Treatment and study plan

Brivanib

Drug

Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity

Other names: BMS-582664

Primary outcomes

  1. Maximum observed plasma concentration (Cmax) of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

  2. Trough observed plasma concentration (Cmin) of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

  3. Time of maximum observed plasma concentration (Tmax) of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

  4. Area under the plasma concentration-time curve from time zero to the end of the dosing interval [AUC(TAU)] of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

  5. Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

  6. Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

  7. Terminal half-life (T-HALF) of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

  8. Accumulation index calculated as the ratio: AUC(TAU) at steady-state (Day 8) divided by AUC(TAU) after the first dose (Day 1) [AI] of Brivanib

    Time frame: Days 1, 2, 8, 9 and 15

Secondary outcomes

  1. Safety assessments based on adverse event reports and the results of vital sign measurements, electrocardiograms (ECGs), 2-D Echocardiograms, physical examinations and clinical laboratory tests

    Time frame: Part A: Day 1-Week 1, Day 8-Week 2, Day 15-Week 3 and Day 29-Week 5, Part B: End of treatment (approximately 24 months)

  2. Preliminary evidence of anti-tumor activity as measured by objective response rate (ORR) and disease control rate (DCR) in Chinese subjects with advanced HCC treated with Brivanib

    Time frame: Screening, Week 7 and every 6 weeks up to End of treatment (approximately 24 months)

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Feb 28, 2012
Registry last updated
Jul 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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