Phase III Trans-Arterial Chemo-Embolization (TACE) Adjuvant HCC - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00908752

Purpose

The purpose of this study is to compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy.

Condition	Intervention	Phase
Hepatocellular Carcinoma	Drug: Brivanib Drug: Brivanib Placebo	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, Multicenter Phase III Study of Brivanib Versus Placebo as Adjuvant Therapy to Trans-Arterial Chemo-Embolization (TACE) in Patients With Unresectable Hepatocellular Carcinoma (The BRISK TA Study)

Resource links provided by NLM:

Drug Information available for: BMS540215

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To compare the Overall Survival (OS) of HCC patients who receive brivanib as adjuvant treatments to TACE therapy, with the OS of HCC patients who receive matched placebo with TACE therapy [ Time Frame: Survival will be assessed continuously ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare the Time-To-Disease Progression (TTDP) of patients receiving brivanib with TACE therapy to that of patients receiving placebo with TACE therapy [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
To compare the time to extrahepatic spread or vascular invasion in the brivanib and placebo arms [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
To determine the total number of TACE sessions in the brivanib and placebo arms and to compare the rate of TACE sessions in the brivanib and placebo arms [ Time Frame: End of Study ] [ Designated as safety issue: No ]
To evaluate the safety of brivanib in combination with TACE [ Time Frame: Every 8 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	870
Study Start Date:	August 2009
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Brivanib: Active Comparator	Drug: Brivanib Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
Brivanib Placebo: Placebo Comparator	Drug: Brivanib 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

Inclusion Criteria:

Patients with diagnosis of hepatocellular carcinoma
One lesion that is ≥ 5 cm, OR multinodular disease with 4 or more lesions (at least one of which has a diameter > 3 cm)
Cirrhotic status of Child-Pugh Class A or B with a score of 7
ECOG performance status of 0 or 1
Adequate hematologic, hepatic, and renal function

Exclusion criteria:

Prior use of any systemic anticancer chemotherapy, immunotherapy, investigational or molecular targeted agents for HCC
History of cardiac disease
Active and untreated hepatitis B
Inability to swallow tablets or untreated malabsorption syndrome
History of human immunodeficiency virus (HIV) infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00908752

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 104 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:	NCT00908752 History of Changes
Other Study ID Numbers:	CA182-037, EUDRACT # 2008-008715-26
Study First Received:	May 22, 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; Canada: Health Canada; China: State Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Hong Kong: Department of Health; Italy: Istituto Superiore de Sanita (ISS); Japan: Pharmaceuticals and Medical Devices Agency; Korea: Food and Drug Administration; Spain: Agencia Espanola del Medicamento y Productos Sanitarios; Taiwan: Department of Health; Thailand: Food and Drug Administration; United States: Food and Drug Administration

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 September 07, 2010