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

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

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.

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.