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:
Bristol-Myers Squibb
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
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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
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 | |
| Mount Sinai School Of Medicine | |
| New York, New York, United States, 10029 | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| 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, H3G 1A4 | |
| Local Institution | |
| Montreal, Quebec, Canada, H1T 2M4 | |
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 Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013