First Line Hepato Cellular Carcinoma (HCC) - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00858871

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 III

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:

Drug Information available for: Sorafenib Sorafenib tosylate BMS540215

U.S. FDA Resources

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 ]

Estimated Enrollment:	1050
Study Start Date:	May 2009
Estimated Study Completion Date:	February 2013
Estimated Primary Completion Date:	February 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Brivanib: Active Comparator	Drug: Brivanib Tablets, Oral, 800 mg, Once Daily, Until disease progression or unacceptable toxicity Drug: Placebo Capsules, Oral, twice Daily, Until disease progression or unacceptable toxicity
Sorafenib: Active Comparator	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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00858871

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 197 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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 ( Study Director )
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:	August 30, 2010
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: State Food and Drug Administration; Czech Republic: State Institute for Drug Control; France: Afssaps - French Health Products Safety Agency; 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 and Social Development 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
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site

Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 07, 2010