Protocol Summary

Protocol No.: 14792

Sponsor Protocol No.: 39039039 STM4001

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

Principal Investigator(s)
Rajasekhar, Anita

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 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.

Phase: Phase III

Age Group: Adult

Scope: National

Participants will be administered rivaroxaban 10 milligram (mg) tablet or placebo tablet orally once daily for 180 days.

Detailed Eligibility
1. Ages 18 years old and older
2. 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
3. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
4. Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
5. Creatinine clearance (CrCl) >= 30 milliliter per minute (mL/min)
6. 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

1. Diagnosis of primary brain tumors
2. Known history of brain metastases
3. Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with a high risk for bleeding
4. Hematologic malignancies with the exception of lymphoma
5. Platelet count less than (

Applicable Disease Sites
Supportive Care Trials

Participating Institutions
UF Gainesville : Anita Rajasekhar

Anita Rajasekhar, MD
Phone: 352-273-8699


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