Phase 2
Completed N=130
A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
Source: ClinicalTrials.gov NCT00320255 ↗Enrolled (actual)
130
Serious AEs
18.9%
Results posted
Aug 2016
Primary outcomePrimary: Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding — 1; 1; 1; 4 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Composite of Confirmed Major Bleeding and Clinically Relevant Nonmajor (CRNM) Bleeding |
1; 1; 1; 4; 2; 3 | — |
| SECONDARY Number of Participants With Composite of Venous Thromboembolism (VTE) and All-cause Death |
4; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and All-cause Death |
3; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Composite of Venous Thromboembolism (VTE) and VTE-related Death |
4; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Composite of Proximal Deep Vein Thrombosis (DVT), Nonfatal Pulmonary Embolism (PE), and Venous Thromboembolism (VTE)-Related Death |
3; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With All-Cause Death |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Pulmonary Embolism (Fatal or Nonfatal) |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Nonfatal Pulmonary Embolism |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Deep Vein Thrombosis |
4; 0; 0; 1; 0; 0 | — |
| SECONDARY Number of Participants With Distal Deep Vein Thrombosis |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Proximal Deep Vein Thrombosis |
3; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants Who Died and With Adverse Events (AEs), Serious Adverse Events (SAEs), Bleeding AEs, and Discontinuations Due to AEs |
2; 1; 0; 0; 0; 0 | — |
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 200 mm Hg and/or diastolic blood pressure >110 mm Hg
- Coagulopathy (international normalized ratio >1.5 or platelet count 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.
Data sourced from ClinicalTrials.gov (NCT00320255). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.