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
Phase 2
18 Years
90 Years
18 Years
90 Years
Not Enrolling
Both
Thrombosis, Cancer, Pulmonary Embolism
Both
Thrombosis, Cancer, Pulmonary Embolism
Trial Information
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
The occurrence of either a major bleeding (fatal or non-fatal) event or a clinically relevant non-major bleeding event
Outcome Time Frame:
during the treatment period
Safety Issue:
Yes
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
CV185-027
NCT ID:
NCT00320255
Start Date:
June 2006
Completion Date:
January 2009
Related Keywords:
- Thrombosis
- Cancer
- Pulmonary Embolism
- anticoagulant
- Embolism
- Pulmonary Embolism
- Thromboembolism
- Thrombosis
Name | Location |
|---|---|
| Arizona Cancer Center | Tucson, Arizona 85724 |
| Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
| Mount Sinai School of Medicine | New York, New York 10029 |
| University of Rochester | Rochester, New York 14642 |
| Nevada Cancer Institute | Las Vegas, Nevada 89135 |
| University Of Texas Md Anderson Cancer Ctr | Houston, Texas 77030 |
| Univ. Of Southern Calif. /Norris Comprehensive Cancer Center | Los Angeles, California 90033 |
| Dana-Farber Cancer Inst | Boston, Massachusetts 02115 |
