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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01540461
First received: February 23, 2012
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Hepatocellular Carcinoma
 Drug: Brivanib
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 12
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01540461     History of Changes
Other Study ID Numbers: CA182-064
Study First Received: February 23, 2012
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration
China: State Administration of Traditional Chinese Medicine of the People's Republic of China
China: Ministry of Health

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

ClinicalTrials.gov processed this record on May 19, 2013