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First Line Hepato Cellular Carcinoma (HCC) (BRISK FL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00858871
First received: March 9, 2009
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The purpose of this study is to compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic therapy.


Condition Intervention Phase
Hepato Cellular Carcinoma (HCC)
Drug: Brivanib
Drug: Placebo
Drug: Sorafenib
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 Versus Sorafenib as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • To compare the overall survival of brivanib versus sorafenib in subjects with advanced HCC who have not received prior systemic treatment [ Time Frame: Survival will be assessed continuously ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the time to progression (TTP) (investigator assessed using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare the investigator assessed objective response rate (ORR) and disease control rate (DCR) using modified RECIST criteria for HCC [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To determine duration of response, duration of disease control, and time to response (TTR) [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To assess the safety profile of brivanib and sorafenib [ Time Frame: Every 6 weeks ] [ Designated as safety issue: Yes ]
  • To explore PK and exposure-response in the study population [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare time to symptomatic progression [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]
  • To compare health-related quality of life [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 1714
Study Start Date: May 2009
Study Completion Date: September 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Brivanib Drug: Brivanib
Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity
Other Name: BMS-582664
Drug: Placebo
Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
Active Comparator: Sorafenib Drug: Sorafenib
Capsules, Oral, 800 mg, twice daily, Until disease progression or unacceptable toxicity
Drug: Placebo
Tablets, Oral, Once Daily, Until disease progression or unacceptable 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 HCC: disease not eligible for surgical and/or locoregional therapies OR progressive disease after surgical and/or locoregional therapies
  • Child-Pugh Class A
  • ECOG performance status 0-1
  • Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

  • Prior use of any systemic anti-cancer chemotherapy, immunotherapy or molecular targeted agents for HCC
  • History of active cardiac disease
  • Thrombotic or embolic events within the past 6 months (except HCC tumor thrombus)
  • Any other hemorrhage/bleeding event >= CTCAE Grade 3 within 8 weeks except for esophageal or gastric varices
  • Inability to swallow tablets or untreated malabsorption syndrome
  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: NCT00858871

  Show 173 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: NCT00858871     History of Changes
Other Study ID Numbers: CA182-033, EUDRACT # 2008-003533-24
Study First Received: March 9, 2009
Last Updated: February 12, 2014
Health Authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Agence Fédérale des Médicaments et des Produits de Santé
Brazil: National Health Surveillance Agency
Canada: Health Canada
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Bundeinstitut fur Arzneimittel und Medizinprodukte (BfArM)
India: Central Drugs Standard Control Organization
Hong Kong: Department of Health
Italy: Istituto Superiore de Sanita (ISS)
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Mexico: Federal Commission for Sanitary Risks Protection
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Lakemedelverket
Taiwan: Department of Health
Thailand: Food and Drug Administration
Turkey: T.C. Saglik Bakanligi Ilac Eczacilik Genel Mudurlugu
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014