Phase 3 N=841 Randomized Triple-blind Prevention

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

Neoplasms

Bottom Line

View on ClinicalTrials.gov: NCT02555878 ↗

Enrolled (actual)

841

Serious AEs

32.4%

Results posted

Sep 2019

Primary outcome: Primary: Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) — 8.79; 5.95; 1.90; 2.14 Percentage of participants — p== 0.101

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Rivaroxaban (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Janssen Research & Development, LLC
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)	8.79; 5.95; 1.90; 2.14; 1.19; 0.48	= 0.101
PRIMARY Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)	0.99; 1.98	= 0.265
SECONDARY Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths	5.23; 3.81	—
SECONDARY Percentage of Participants With All-Cause Mortality	23.8; 20.0	—
SECONDARY Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)	1.66; 0.95	—
SECONDARY Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE	0.48; 0.24	—
SECONDARY Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1	29.5; 23.1	—
SECONDARY Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2	5.23; 3.81	—
SECONDARY Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3	10.7; 6.90	—
SECONDARY Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4	6.89; 5.71	—
SECONDARY Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding	1.98; 2.72	—
SECONDARY Percentage of Participants With Time to the First Occurrence of Minor Bleeding	3.96; 6.91	—
SECONDARY Percentage of Participants With Time to the First Occurrence of Any Bleeding	6.44; 11.1	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02555878). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.