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

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ClinicalTrials.gov Identifier: NCT01540461
Recruitment Status : Completed
First Posted : February 28, 2012
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Brivanib Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1 Study to Determine the Safety and Pharmacokinetics of Brivanib in Chinese Subjects With Advanced Hepatocellular Carcinoma (HCC)
Study Start Date : March 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm: Brivanib Drug: Brivanib
Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity
Other Name: BMS-582664



Primary Outcome Measures :
  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 Outcome Measures :
  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) ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540461


Locations
China, Beijing
Local Institution
Beijing, Beijing, China, 100071
China, Heilongjiang
Local Institution
Ha Erbin, Heilongjiang, China, 150040
China, Jiangsu
Local Institution
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01540461     History of Changes
Other Study ID Numbers: CA182-064
First Posted: February 28, 2012    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: June 2014

Keywords provided by Bristol-Myers Squibb:
HCC

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases