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



Status:Completed
Conditions:Cancer, Cancer, Cardiology, Cardiology, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology
Healthy:No
Age Range:18 - Any
Updated:9/29/2018
Start Date:September 11, 2015
End Date:August 24, 2018

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Efficacy and Safety of Rivaroxaban Prophylaxis Compared With Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

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.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group,
superiority study comparing the efficacy and safety of rivaroxaban with placebo for primary
prophylaxis of venous thromboembolism (VTE) in ambulatory adult participants, with various
cancer types who are scheduled to initiate systemic cancer therapy. The study consists of 3
Phases: Screening Phase (14 Days), double-blind treatment Phase (180 Days) and follow up
Phase (30 Days). The duration of participation in the study for each participant is
approximately 32 weeks.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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