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

August 22, 2019 updated by: Janssen Research & Development, LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
841

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Amberloup, Belgium
      • Bonheiden, Belgium
      • Brussel, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Laken (brussel), Belgium
      • Turnhout, Belgium
      • Wilrijk, Belgium
  • Brazil
      • Barretos, Brazil
      • Caxias do Sul, Brazil
      • Curitiba, Brazil
      • Itajai, Brazil
      • Lajeado, Brazil
      • Londrina, Brazil
      • Mogi das Cruzes, Brazil
      • Porto Alegre, Brazil
      • Porto Alegre, Rs, Brazil
      • Rio de Janeiro, Brazil
      • Santo André, Brazil
      • Sao Jose do Rio Preto, Brazil
      • Sao Paulo, Brazil
      • Sorocaba, Brazil
      • São Paulo, Brazil
  • Bulgaria
      • Plovdiv, Bulgaria
      • Plovdiv N/a, Bulgaria
      • Sofia, Bulgaria
  • Canada
      • Quebec, Canada
    • Ontario
      • Toronto, Ontario, Canada
    • Quebec
      • Saint-Jerome, Quebec, Canada
  • Czechia
      • Benesov Nad Cernou, Czechia
      • Brno, Czechia
      • Jindrichuv Hradec, Czechia
      • Kladno, Czechia
      • Liberec, Czechia
      • Novy Jicin, Czechia
      • Olomouc, Czechia
      • Pardubice, Czechia
      • Praha 4, Czechia
      • Praha 5, Czechia
      • Tabor, Czechia
  • France
      • Angers, France
      • Angers Cedex 9, France
      • Avignon Cedex 9, France
      • Dijon Cedex, France
      • Hyers, France
      • Le Mans Cedex 2, France
      • Le Mans cedex 9, France
      • Paris, France
      • Rennes Cedex, France
      • Saint Herblain, France
      • Valenciennes, France
  • Germany
      • Berlin, Germany
      • Brandenburg, Germany
      • Dortmund, Germany
      • Dresden, Germany
      • Esslingen, Germany
      • Gauting, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Herne, Germany
      • Kiel, Germany
      • Koeln, Germany
      • Leipzig, Germany
      • Luebeck, Germany
      • Magdeburg, Germany
      • Merseburg, Germany
      • Minden, Germany
      • München, Germany
      • Paderborn, Germany
      • Recklinghausen, Germany
      • Weiden, Germany
  • Russian Federation
      • Arkhangelsk, Russian Federation
      • Chelyabinsk, Russian Federation
      • Kursk, Russian Federation
      • Moscow, Russian Federation
      • Novosibirsk, Russian Federation
      • Omsk, Russian Federation
      • Saint Petersburg, Russian Federation
      • St Petersburg, Russian Federation
      • Tomsk, Russian Federation
      • Yaroslavi, Russian Federation
  • United Kingdom
      • Bournemouth, United Kingdom
      • Cheltenham, United Kingdom
      • Dundee, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Plymouth, United Kingdom
      • Swindon, United Kingdom
  • United States
    • Arizona
      • Phoenix, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Los Angeles, California, United States
      • Martinez, California, United States
      • Santa Barbara, California, United States
      • Torrance, California, United States
      • Upland, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • Norwich, Connecticut, United States
    • Florida
      • Gainesville, Florida, United States
      • Miami, Florida, United States
      • Miami Shores, Florida, United States
      • New Port Richey, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Evanston, Illinois, United States
      • Joliet, Illinois, United States
      • Peoria, Illinois, United States
      • Rockford, Illinois, United States
      • Skokie, Illinois, United States
      • Urbana, Illinois, United States
    • Indiana
      • Anderson, Indiana, United States
    • Iowa
      • Cedar Rapids, Iowa, United States
    • Maine
      • Brewer, Maine, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Silver Spring, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Michigan
      • Detroit, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
      • Saint Cloud, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
    • Nebraska
      • Grand Island, Nebraska, United States
    • Nevada
      • Las Vegas, Nevada, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New York
      • Albany, New York, United States
      • Bronx, New York, United States
      • East Syracuse, New York, United States
      • New York, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • High Point, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Erie, Pennsylvania, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • Greenville, South Carolina, United States
      • North Charleston, South Carolina, United States
    • South Dakota
      • Rapid City, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Abilene, Texas, United States
      • Austin, Texas, United States
      • Beaumont, Texas, United States
      • Bedford, Texas, United States
      • Dallas, Texas, United States
      • Denton, Texas, United States
      • Flower Mound, Texas, United States
      • Garland, Texas, United States
      • Houston, Texas, United States
      • Paris, Texas, United States
      • San Antonio, Texas, United States
      • Sugar Land, Texas, United States
      • Temple, Texas, United States
      • The Woodlands, Texas, United States
      • Tyler, Texas, United States
      • Waco, Texas, United States
    • Virginia
      • Roanoke, Virginia, United States
      • Winchester, Virginia, United States
    • Wisconsin
      • Green Bay, Wisconsin, United States
      • Weston, Wisconsin, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Rivaroxaban
Participants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Drug: Rivaroxaban
Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.
Experimental: Placebo
Participants will be administered matching placebo tablet orally once daily for 180 days.
Drug: Placebo
Placebo tablet will be administered orally once daily for 180 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)
Time Frame: Up to Day 180
Percentage of participants with time to the first occurrence of primary efficacy endpoint (composite and components) was reported. The primary efficacy composite endpoint is time to first occurrence of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE, or VTE-related death as adjudicated by an independent blinded Clinical Endpoint Committee (CEC).
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)
Time Frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Major bleeding is defined as clinically overt bleeding that is associated with a reduction in hemoglobin of 2 gram per deciliter (g/dL) or more, or a transfusion of 2 or more units of packed red blood cells or whole blood, or occurrence at a critical site defined as intracranial, intra-spinal, intraocular, pericardial, intra-articular, intra-muscular with compartment syndrome, retroperitoneal, or fatal outcome.
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths
Time Frame: Up to Day 180
Percentage of participants with time to first occurrence of the composite endpoint of symptomatic VTE events (symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, or symptomatic non-fatal PE) or VTE related deaths as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Up to Day 180
Percentage of Participants With All-Cause Mortality
Time Frame: Up to Day 180
Percentage of participants with all-cause mortality as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported. Overall deaths occurred during observation period (defined by start to end date of the observation period [that is approximately 180 days] are reported here.
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)
Time Frame: Up to Day 180
Percentage of participants with time to first occurrence of fatal/non-fatal ATE (a composite of occurrence of myocardial infarction (MI), stroke [ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma] or any other ATE recorded) event as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE
Time Frame: Up to Day 180
Percentage of participants with time to the first occurrence of fatal or non-fatal visceral VTE as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1
Time Frame: Up to Day 180
Percentage of participants with time to first occurrence of composite efficacy endpoint 1 (composite of objectively confirmed symptomatic and asymptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, incidental PE or all-cause mortality) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Up to Day 180
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2
Time Frame: Up to Day 180
Percentage of participants with time to first occurrence of composite efficacy endpoint 2 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE or VTE-related deaths) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Up to Day 180
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3
Time Frame: Up to Day 180
Percentage of participants with time to first occurrence of composite efficacy endpoint 3 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, asymptomatic lower extremity proximal DVT, symptomatic non-fatal PE, incidental PE, VTE-related deaths, fatal/non-fatal ATE [MI, stroke {ischemic infarction with or without hemorrhagic conversion or primary hemorrhagic events - intraparenchymal hemorrhage, subdural hematoma or epidural hematoma} or any ATE] or fatal/non-fatal visceral VTE) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Up to Day 180
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4
Time Frame: Up to Day 180
Percentage of participants with time to first occurrence of composite efficacy endpoint 4 (composite of objectively confirmed symptomatic lower extremity proximal DVT, symptomatic lower extremity distal DVT, symptomatic upper extremity DVT, symptomatic non-fatal PE, VTE-related deaths or major bleeding events up to Day 180) as adjudicated by an independent blinded CEC up-to-Day 180 observation period was reported.
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding
Time Frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Percentage of participants with time to the first occurrence of clinically relevant non-major bleeding was reported. Clinically relevant non-major bleeding is defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, or unscheduled contact with a physician, or temporary cessation of study treatment, or discomfort such as pain, or impairment of activities of daily life.
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Percentage of Participants With Time to the First Occurrence of Minor Bleeding
Time Frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Percentage of participants with time to the first occurrence of minor bleeding was reported. Minor bleeding (that is, minimal bleeding) is defined as overt bleeding episodes not meeting the criteria for major or clinically relevant non-major bleeding event.
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Percentage of Participants With Time to the First Occurrence of Any Bleeding
Time Frame: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Percentage of participants with time to the first occurrence of any bleeding event was reported. Any bleeding is defined as a composite of major bleeding, clinically relevant non-major bleeding, or minor bleeding.
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 18, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR107047
  • 39039039STM4001 (Other Identifier: Janssen Research & Development, LLC)
  • 2015-001630-21 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings