Conditions: Thrombosis Cancer Pulmonary Embolism
Keywords: anticoagulant
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

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 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.

Detailed description:

Arms:
arm 1: Participants received placebo tablets once daily arm 2: Participants received apixaban as tablet, 5 mg, once daily arm 3: Participants received apixaban as tablet, 10 mg, once daily arm 4: Participants received apixaban as tablet, 20 mg, once daily arm 5: Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily. arm 6: Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.

Interventions: intervention 1: Apixaban intervention 2: Placebo
Intervention descriptions: intervention 1: Oral tablets administered once daily in 5-, 10-, or 20-mg dose intervention 2: Oral tablets administered once daily

Protocol document: