Status:
COMPLETED
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Lead Sponsor:
Bristol-Myers Squibb
Collaborating Sponsors:
Ontario Clinical Oncology Group (OCOG)
Conditions:
Thrombosis
Cancer
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to learn whether apixaban is well-tolerated and acceptable as anticoagulant therapy, when administered to patients with advanced or metastatic cancer and at increased risk...
Eligibility Criteria
Inclusion
- Key
- Recipients of either first- or second-line chemotherapy for advanced or metastatic lung, breast, gastrointestinal, bladder, ovarian, or prostate cancer or myeloma, selected lymphomas, or cancer of unknown origin
- Able to begin study medication ≤6 weeks of starting either first- or second-line chemotherapy.
- Expected course of chemotherapy must have been ≥ 90 days after the start of chemotherapy
- Per Protocol Amendment 5, patients receiving bevacizumab were eligible to participate, provided that bevacizumab was used for indications approved by local country law
- Key
Exclusion
- Women who are pregnant, breastfeeding
- History of deep vein thrombosis or pulmonary embolism
- Active bleeding or at high risk of bleeding
- Metastatic brain cancer
- Familial bleeding diathesis
- Serious hemorrhage requiring hospitalization, transfusion, or surgical intervention within 4 weeks of study entry
- Expected survival \<6 months or an Eastern Cooperative Oncology Group performance status ≥3.
- Candidates for bone marrow transplantation within the 12-week treatment period or 30-day follow-up period
- Uncontrolled hypertension (systolic blood pressure \>200 mm Hg and/or diastolic blood pressure \>110 mm Hg
- Coagulopathy (international normalized ratio \>1.5 or platelet count \<100\*10\^9/L) if not yet receiving chemotherapy or \<50\*10\^9/L if receiving chemotherapy). Platelet count must have been \>100\*10\^9/L before starting study medication
- One or more of the following: alanine aminotransferase \>3 times the upper limit of normal (ULN), total bilirubin \>2\*ULN, or calculated creatinine clearance \<30 mL/min.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT00320255
Start Date
June 1 2006
End Date
January 1 2009
Last Update
August 16 2016
Active Locations (14)
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1
Arizona Cancer Center
Tucson, Arizona, United States, 85724
2
Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
3
Dana-Farber Cancer Inst
Boston, Massachusetts, United States, 02115
4
Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135