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

Key Inclusion Criteria:

• Recipients of either first- or second-line chemotherapy for advanced or metastaticlung, 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-linechemotherapy.

• Expected course of chemotherapy must have been ≥ 90 days after the start ofchemotherapy

• 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 interventionwithin 4 weeks of study entry

• Expected survival <6 months or an Eastern Cooperative Oncology Group performancestatus ≥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 bloodpressure >110 mm Hg

• Coagulopathy (international normalized ratio >1.5 or platelet count <10010^9/L) ifnot yet receiving chemotherapy or <5010^9/L if receiving chemotherapy). Plateletcount must have been >100*10^9/L before starting study medication

• One or more of the following: alanine aminotransferase >3 times the upper limit ofnormal (ULN), total bilirubin >2*ULN, or calculated creatinine clearance <30 mL/min.