A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
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 for venous thromboembolic events. 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.
Checked against the public recordLast updated Aug 16, 2016 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: Apixaban; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * 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 Criteria: * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Cancer CenterTucson, Arizona
- Univ. Of Southern Calif. /Norris Comprehensive Cancer CenterLos Angeles, California
- Dana-Farber Cancer InstBoston, Massachusetts
- Nevada Cancer InstituteLas Vegas, Nevada
- Memorial Sloan-Kettering Cancer CenterNew York, New York
- Mount Sinai School Of MedicineNew York, New York
- University Of RochesterRochester, New York
- University Of Texas Md Anderson Cancer CtrHouston, Texas
- Local InstitutionHamilton, Ontario
- Local InstitutionLondon, Ontario
- Local InstitutionToronto, Ontario
- Local InstitutionToronto, Ontario
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 16, 2016. Always confirm current availability with the study team.