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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001630-21-GB

Enrollment

700

Registered

2015-10-08

Start date

2015-12-15

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous thromboembolism (VTE) MedDRA version: 19.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866

Interventions

Trade Name: XARELTO® 10 mg Product Name: Rivaroxaban Product Code: JNJ-39039039/BAY 59-7939 Pharmaceutical Form: Film-coated tablet INN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - 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 02 - 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 +/- 1 week of receiving the first dose of study drug with the intent of receiving systemic cancer therapy during the double-blind treatment period with for an intended duration determined by the treating oncologist according to standard protocols of clinical care. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 560 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 140

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary efficacy objective 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 DVT, asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, and VTE-related death in ambulatory adult subjects with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE. ;Secondary Objective: The key secondary efficacy objectives of this study are to compare the efficacy of rivaroxaban with placebo for reducing the risk of symptomatic VTE events and VTE-related deaths and all-cause mortality in ambulatory adult subjects with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE. Other secondary efficacy objectives include the evaluation of the individual components of the primary efficacy composite variable confirmed confirmed fatal/non-fatal arterial thromboembolism (ATE) events,confirmed fatal/non-fatal visceral VTE events, symptomatic lower extremity proximal DVT, asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, non-fatal PE, incidental PE and all-cause mortality and a composite of symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE and VET-related deaths.; Primary end point(s): 1) Primary Efficacy Composite Endpoint is Time From Randomization to First Occurrence of Objectively Confirmed Symptomatic and Asymptomatic Lower Extremity Proximal DVT,Symptomatic Upper Extremity DVT, Symptomatic Non-Fatal PE, Incidental PE, VTE-Related Death 2) The Primary Safety Objective of This Study is to Assess the Major Bleeding Events as Defined by ISTH ; Timepoint(s) of evaluation of this end point: 1) From	—

Measure

Time frame

Main Objective: The primary efficacy objective 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 DVT, asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, and VTE-related death in ambulatory adult subjects with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE. ;Secondary Objective: The key secondary efficacy objectives of this study are to compare the efficacy of rivaroxaban with placebo for reducing the risk of symptomatic VTE events and VTE-related deaths and all-cause mortality in ambulatory adult subjects with various cancer types receiving systemic cancer therapy who are at high risk of developing a VTE. Other secondary efficacy objectives include the evaluation of the individual components of the primary efficacy composite variable confirmed confirmed fatal/non-fatal arterial thromboembolism (ATE) events,confirmed fatal/non-fatal visceral VTE events, symptomatic lower extremity proximal DVT, asymptomatic lower extremity proximal DVT, symptomatic upper extremity DVT, non-fatal PE, incidental PE and all-cause mortality and a composite of symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE and VET-related deaths.; Primary end point(s): 1) Primary Efficacy Composite Endpoint is Time From Randomization to First Occurrence of Objectively Confirmed Symptomatic and Asymptomatic Lower Extremity Proximal DVT,Symptomatic Upper Extremity DVT, Symptomatic Non-Fatal PE, Incidental PE, VTE-Related Death 2) The Primary Safety Objective of This Study is to Assess the Major Bleeding Events as Defined by ISTH ; Timepoint(s) of evaluation of this end point: 1) From

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Secondary

Measure	Time frame
Secondary end point(s): 1) Efficacy endpoint: Symptomatic VTE Events and VTE Related Deaths 2) Efficacy endpoint: All-cause Mortality 3) Safety Endpoints Include the Proportion of Clinically Relevant Non-Major Bleeding, Minor Bleeding, any Bleeding (Defined as Major, Clinically Relevant Non-Major, and Minor Bleeding) 4) Safety endpoint: All-cause Mortality 5) Number of Participants with Adverse Events (AEs) and Serious AEs ; Timepoint(s) of evaluation of this end point: 1) and 2): Up to Day 180+3 3) From the Time of Randomization to Two Days After the Last Dose of Study Drug 4) Up to Day 180 5) Screening up to follow-up (30 days after last dose administration)	—

Measure

Time frame

Secondary end point(s): 1) Efficacy endpoint: Symptomatic VTE Events and VTE Related Deaths 2) Efficacy endpoint: All-cause Mortality 3) Safety Endpoints Include the Proportion of Clinically Relevant Non-Major Bleeding, Minor Bleeding, any Bleeding (Defined as Major, Clinically Relevant Non-Major, and Minor Bleeding) 4) Safety endpoint: All-cause Mortality 5) Number of Participants with Adverse Events (AEs) and Serious AEs ; Timepoint(s) of evaluation of this end point: 1) and 2): Up to Day 180+3 3) From the Time of Randomization to Two Days After the Last Dose of Study Drug 4) Up to Day 180 5) Screening up to follow-up (30 days after last dose administration)

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Countries

Belgium, Bulgaria, Canada, Czech Republic, Germany, United Kingdom, United States

Contacts

Public ContactDaniel Yannicelli

Janssen Research and Development, LLC

HYannice@its.jnj.com+1908927 5625

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026