A Phase 2 Pilot Study of Apixaban for the Prevention of Thromboembolic Events in Patients With Advanced (Metastatic) Cancer
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.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 16, 2016 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Prevention
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Bristol-Myers Squibb
- Interventions being studied
- Drug: Apixaban; Drug: Placebo
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key
- 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
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Cancer CenterTucson, Arizona
- Univ. Of Southern Calif. /Norris Comprehensive Cancer CenterLos Angeles, California
- Dana-Farber Cancer InstBoston, Massachusetts
- Nevada Cancer InstituteLas Vegas, Nevada
- Memorial Sloan-Kettering Cancer CenterNew York, New York
- Mount Sinai School Of MedicineNew York, New York
- University Of RochesterRochester, New York
- University Of Texas Md Anderson Cancer CtrHouston, Texas
- Local InstitutionHamilton, Ontario
- Local InstitutionLondon, Ontario
- Local InstitutionToronto, Ontario
- Local InstitutionToronto, Ontario
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 16, 2016. Always confirm current availability with the study team.