A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Condition: Thrombosis; Cancer; Pulmonary Embolism
MeSH terms: Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism
Intervention: Apixaban; Placebo
Intervention description: Oral tablets administered once daily in 5-, 10-, or 20-mg dose; Oral tablets administered once daily
Intervention MeSH terms: Apixaban
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 130.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: anticoagulant

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 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.
    

Eligibility criteria:

        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.