Trial record 1 of 2 for:    Comparison of Brivanib and Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment
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Comparison of Brivanib and Best Supportive Care to Placebo for Treatment of Liver Cancer for Those Subjects Who Have Failed Sorafenib Treatment (BRISK PS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00825955
First received: January 20, 2009
Last updated: August 28, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to determine if Brivanib is an effective treatment for liver cancer in patients who have failed or could not take Sorafenib


Condition Intervention Phase
Liver Cancer
Drug: Brivanib
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Multi-center Phase III Study of Brivanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed or Are Intolerant to Sorafenib: The BRISK PS Study (Brivanib Study in HCC Patients at Risk Post Sorafenib)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare overall survival of subjects with advanced HCC who have progressed on/after or are intolerant to Sorafenib and receive Brivanib plus best supportive care (BSC) to those receiving placebo plus BSC [ Time Frame: computerized tomography (CT)/ magnetic resonance imaging (MRI) every six weeks until progression or death ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare time to progression (TTP) (Investigator assessed using modified Response Evaluation Criteria In Solid Tumors (RECIST) for HCC criteria) [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • To compare the Independent Radiological Review Committee (IRRC) assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST for HCC criteria [ Time Frame: 35 months ] [ Designated as safety issue: No ]
  • To assess duration of response, duration of disease control and time to response [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • To assess safety profile of brivanib. Safety will be assessed by the number of adverse events (AEs), serious adverse events (SAEs), periodic data monitoring committee (DMC) review [ Time Frame: 35 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 414
Study Start Date: February 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brivanib Drug: Brivanib
Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
Other Name: BMS-582664
Placebo Comparator: Placebo Drug: Placebo
Tablets, Oral, 0 mg, once daily, until disease progression or toxicity

  Eligibility

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

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

Inclusion Criteria:

  • Histologic or cytologic confirmed diagnosis of HCC
  • Advanced disease defined as (i) disease not eligible for surgical or loco-regional therapy or (ii) disease progressive after surgical or loco-regional therapy
  • Patient has failed ≥ 14 days of Sorafenib treatment
  • Cirrhotic status of Child-Pugh Class A or B with a score of 7
  • Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2
  • Subjects who have a life expectancy of at least 8 weeks
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy
  • Previous or concurrent cancer that is distinct in primary site
  • History of active cardiac disease
  • Thrombotic or embolic events within the past 6 months
  • Any other hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 within 4 weeks
  • Inability to swallow tablets or untreated malabsorption syndrome
  • History of human immunodeficiency virus (HIV) infection
  • Prior use of systemic investigational agents for HCC (except for Sorafenib)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00825955

  Show 113 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00825955     History of Changes
Other Study ID Numbers: CA182-034, EUDRACT #: 2008-005084-34
Study First Received: January 20, 2009
Last Updated: August 28, 2014
Health Authority: Brazil: Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Canada: Health Canada
Mexico: Federal Commission for Protection Against Health Risks
United States: Food and Drug Administration
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Belgium: Federal Agency for Medicinal Products and Health Products
Spain: Spanish Agency of Medicines
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Italy: National Institute of Health
Sweden: Lakemedelverket
South Africa: Medicines Control Council
South Africa: Department of Health
Hong Kong: Department of Health
Korea: Food and Drug Administration
Taiwan: Department of Health
Thailand: Food and Drug Administration
China: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Czech Republic: State Institute for Drug Control
Turkey: Ministry of Health
Japan: Japanese Ministry of Health

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sorafenib
Carcinoma, Hepatocellular
Digestive System Diseases
Adenocarcinoma
Carcinoma
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014