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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Neoplasms

Treatments: Drug: Rivaroxaban; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02555878

39039039STM4001 (Other Identifier)

CR107047

2015-001630-21 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 841 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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841 participants in 2 patient groups

Rivaroxaban

Experimental group

Description:

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

Treatment:

Drug: Rivaroxaban

Placebo

Experimental group

Description:

Participants will be administered matching placebo tablet orally once daily for 180 days.

Treatment:

Drug: Placebo