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

This study has been completed.
Sponsor:
Collaborator:
Ontario Clinical Oncology Group (OCOG)
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00320255
First received: April 28, 2006
Last updated: February 28, 2012
Last verified: February 2012
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


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 ]

Enrollment: 129
Study Start Date: June 2006
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Apixaban
Tablets, Oral, 5 mg QD, once daily for 12 weeks
Other Name: BMS-562247
Placebo Comparator: A2 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
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: NCT00320255

Locations
United States, Arizona
Arizona Cancer Center
Tucson, Arizona, United States, 85724
United States, California
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
United States, Massachusetts
Dana-Farber Cancer Inst
Boston, Massachusetts, United States, 02115
United States, Nevada
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Mount Sinai School Of Medicine
New York, New York, United States, 10029
University Of Rochester
Rochester, New York, United States, 14642
United States, Texas
University Of Texas Md Anderson Cancer Ctr
Houston, Texas, United States, 77030
Canada, Ontario
Local Institution
Hamilton, Ontario, Canada, L8V 2C5
Local Institution
London, Ontario, Canada, N6A 4L6
Local Institution
Toronto, Ontario, Canada, M5G 2M9
Local Institution
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Local Institution
Montreal, Quebec, Canada, H1T 2M4
Local Institution
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
Bristol-Myers Squibb
Ontario Clinical Oncology Group (OCOG)
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00320255     History of Changes
Other Study ID Numbers: CV185-027
Study First Received: April 28, 2006
Last Updated: February 28, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:
anticoagulant

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Thromboembolism
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014