A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants

Completed · Phase 3 · Has a placebo group

Conditions studied: Neoplasms

In brief

The purpose of this study is to demonstrate that rivaroxaban is superior to placebo for reducing the risk of the primary composite outcome as defined by objectively confirmed symptomatic lower extremity proximal deep vein thrombosis (DVT), asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal pulmonary embolism (PE), incidental PE, and venous thromboembolism (VTE)-related death in ambulatory adult participants with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE.

Key facts

Study ID

NCT02555878

Run by

Janssen Research & Development, LLC

People needed

841

Starts

2015-09-11

Expected to finish

2018-08-24

Last updated by the study team

2019-09-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Have histologically confirmed solid malignancy including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease
• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
• Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
• Plan to initiate systemic cancer therapy within plus or minus (+-) 1 week of receiving the first dose of study drug with the intention of receiving systemic cancer therapy during the double-blind treatment period for an intended duration determined by the treating oncologist according to standard protocols of clinical care

You may not qualify if…

• Diagnosis of primary brain tumors
• Known history of brain metastases
• Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
• Hematologic malignancies with the exception of lymphoma
• Platelet count less than (<) 50,000/millimeter\^3 (mm\^3), Life expectancy of less than or equal to (<=) 6 months

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Little Rock, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Martinez, California, United States
• Study site — Santa Barbara, California, United States
• Study site — Torrance, California, United States
• Study site — Upland, California, United States
• Study site — Denver, Colorado, United States
• Study site — Norwich, Connecticut, United States
• Study site — Gainesville, Florida, United States
• Study site — Miami, Florida, United States
• Study site — Miami Shores, Florida, United States
• Study site — New Port Richey, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Evanston, Illinois, United States
• Study site — Joliet, Illinois, United States
• Study site — Peoria, Illinois, United States
• Study site — Rockford, Illinois, United States
• Study site — Skokie, Illinois, United States
• Study site — Urbana, Illinois, United States
• Study site — Anderson, Indiana, United States
• Study site — Cedar Rapids, Iowa, United States
• Study site — Brewer, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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