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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01540461
First received: February 23, 2012
Last updated: July 4, 2014
Last verified: June 2014

February 23, 2012
July 4, 2014
March 2012
November 2013   (final data collection date for primary outcome measure)
  • Maximum observed plasma concentration (Cmax) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
  • Trough observed plasma concentration (Cmin) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
  • Time of maximum observed plasma concentration (Tmax) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Average steady state concentration calculated as AUC(TAU)/24 (Css_av) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
  • Degree of fluctuation calculated as ((Cmax- Cmin)/Css_av) [Degree of fluctuation] of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
  • Terminal half-life (T-HALF) of Brivanib [ Time Frame: Days 1, 2, 8, 9 and 15 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01540461 on ClinicalTrials.gov Archive Site
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Determine the Pharmacokinetics and Safety of Brivanib in Chinese Subjects With Advanced Primary Liver Cancer (Hepatocellular Carcinoma: HCC)
A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced 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).

Not Provided
Interventional
Phase 1
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hepatocellular Carcinoma
Drug: Brivanib
Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity
Other Name: BMS-582664
Experimental: Arm: Brivanib
Intervention: Drug: Brivanib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
November 2013
November 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01540461
CA182-064
No
Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP