A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer - Full Text View

Sponsors and Collaborators:	Bristol-Myers Squibb Ontario Clinical Oncology Group
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00320255

Purpose

The purpose of this study is to gain information on whether apixaban, when administered to patients with advanced or metastatic cancer will be well-tolerated and acceptable as anticoagulant therapy. These patients are at increased risk for venous thromboembolic events (VTE). Demonstration of a favorable benefit:risk profile could lead to significant reduction in this serious and sometimes fatal complication of ongoing cancer and its treatment.

Condition	Intervention	Phase
Thrombosis Cancer Pulmonary Embolism	Drug: Apixaban Drug: Placebo	Phase II

MedlinePlus related topics: Blood Thinners Cancer Pulmonary Embolism

Drug Information available for: Apixaban

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Study of Apixaban for the Prevention of Thromboembolic Events in Patients Undergoing Treatment for Advanced Cancer: A Phase 2 Pilot Study

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The occurrence of either a major bleeding (fatal or non-fatal) event or a clinically relevant non-major bleeding event [ Time Frame: during the treatment period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Symptoms compatible with venous thromboembolism [ Time Frame: during the treatment and 30 day follow-up periods ] [ Designated as safety issue: No ]

Estimated Enrollment:	160
Study Start Date:	June 2006
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator	Drug: Apixaban Tablets, Oral, 5 mg QD, once daily for 12 weeks
A2: Placebo Comparator	Drug: Placebo Tablets, Oral, 0 mg, once daily for 12 weeks

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Advanced or metastatic cancer
Chemotherapy for ≥90 days
Enter study within 6 wks start of chemo

Exclusion Criteria:

Women who are pregnant, breastfeeding
Venous Thromboembolic Events (VTE) history
Active/high risk of bleeding
Metastatic brain cancer
Expected survival < 6 months
Bone marrow transplant candidate
Low platelet count
ALT >3xULN, bilirubin > 2xULN, Clcr <30 mL/min
Receiving Plavix® Aggrenox™
Receiving bevacizumab (Avastin™ ) for off-label/investigational indications
Receiving Nexavar® or Sutent® (within 3 months)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320255

Locations

United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, Massachusetts
Dana-Farber Cancer Inst
Boston, Massachusetts, United States, 02115
United States, New York
Mount Sinai School Of Medicine
New York, New York, United States, 10029
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States, 77030
Canada, Ontario
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H3G 1A4

Sponsors and Collaborators

Bristol-Myers Squibb

Ontario Clinical Oncology Group

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CV185-027
Study First Received:	April 28, 2006
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00320255
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

anticoagulant

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Embolism

Lung Diseases
Vascular Diseases
Thrombosis

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009