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

Last updated: August 22, 2019
Sponsor: Janssen Research & Development, LLC
Overall Status: Completed

Phase

3

Condition

Venous Thromboembolism

Venous Thrombosis

Blood Clots

Treatment

N/A

Clinical Study ID

NCT02555878
CR107047
2015-001630-21
39039039STM4001
  • Ages > 18
  • All Genders

Study 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

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 receivingthe first dose of study drug with the intention of receiving systemic cancer therapyduring the double-blind treatment period for an intended duration determined by thetreating oncologist according to standard protocols of clinical care

Exclusion

Exclusion Criteria:

  • Diagnosis of primary brain tumors

  • Known history of brain metastases

  • Bleeding diathesis, hemorrhagic lesions, active bleeding, and other conditions with ahigh risk for bleeding

  • Hematologic malignancies with the exception of lymphoma

  • Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less thanor equal to (<=) 6 months

Study Design

Total Participants: 841
Study Start date:
September 11, 2015
Estimated Completion Date:
August 24, 2018

Study 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.

Connect with a study center

  • Amberloup,
    Belgium

    Site Not Available

  • Bonheiden,
    Belgium

    Site Not Available

  • Brussel,
    Belgium

    Site Not Available

  • Bruxelles,
    Belgium

    Site Not Available

  • Edegem,
    Belgium

    Site Not Available

  • Laken (brussel),
    Belgium

    Site Not Available

  • Turnhout,
    Belgium

    Site Not Available

  • Wilrijk,
    Belgium

    Site Not Available

  • Barretos,
    Brazil

    Site Not Available

  • Caxias do Sul,
    Brazil

    Site Not Available

  • Curitiba,
    Brazil

    Site Not Available

  • CEPON - Centro de Pesquisas Oncologicas de Santa Catarina

    Florianopolis, 88034
    Brazil

    Site Not Available

  • Itajai,
    Brazil

    Site Not Available

  • Lajeado,
    Brazil

    Site Not Available

  • Londrina,
    Brazil

    Site Not Available

  • Mogi das Cruzes,
    Brazil

    Site Not Available

  • Porto Alegre,
    Brazil

    Site Not Available

  • Porto Alegre, Rs,
    Brazil

    Site Not Available

  • Rio de Janeiro,
    Brazil

    Site Not Available

  • Santo André,
    Brazil

    Site Not Available

  • Sao Jose do Rio Preto,
    Brazil

    Site Not Available

  • Sao Jose do Rio Preto,
    Brazil

    Site Not Available

  • Sao Paulo,
    Brazil

    Site Not Available

  • Sorocaba,
    Brazil

    Site Not Available

  • São Paulo,
    Brazil

    Site Not Available

  • Plovdiv,
    Bulgaria

    Site Not Available

  • Plovdiv N/a,
    Bulgaria

    Site Not Available

  • Sofia,
    Bulgaria

    Site Not Available

  • Toronto, Ontario
    Canada

    Site Not Available

  • Niagara Health System

    Welland, Ontario L3B 4W6
    Canada

    Site Not Available

  • Saint-Jerome, Quebec
    Canada

    Site Not Available

  • Quebec,
    Canada

    Site Not Available

  • Benesov Nad Cernou,
    Czechia

    Site Not Available

  • Brno,
    Czechia

    Site Not Available

  • Jindrichuv Hradec,
    Czechia

    Site Not Available

  • Kladno,
    Czechia

    Site Not Available

  • Liberec,
    Czechia

    Site Not Available

  • Novy Jicin,
    Czechia

    Site Not Available

  • Olomouc,
    Czechia

    Site Not Available

  • Pardubice,
    Czechia

    Site Not Available

  • Praha 4,
    Czechia

    Site Not Available

  • Praha 5,
    Czechia

    Site Not Available

  • Tabor,
    Czechia

    Site Not Available

  • Angers,
    France

    Site Not Available

  • Angers Cedex 9,
    France

    Site Not Available

  • Avignon Cedex 9,
    France

    Site Not Available

  • Dijon Cedex,
    France

    Site Not Available

  • Hyers,
    France

    Site Not Available

  • Le Mans Cedex 2,
    France

    Site Not Available

  • Le Mans cedex 9,
    France

    Site Not Available

  • Paris,
    France

    Site Not Available

  • Rennes Cedex,
    France

    Site Not Available

  • Saint Herblain,
    France

    Site Not Available

  • Valenciennes,
    France

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Brandenburg,
    Germany

    Site Not Available

  • Dortmund,
    Germany

    Site Not Available

  • Dresden,
    Germany

    Site Not Available

  • Esslingen,
    Germany

    Site Not Available

  • Gauting,
    Germany

    Site Not Available

  • Hamburg,
    Germany

    Site Not Available

  • St. Vinzenz-Krankenhaus Hanau gGmbH

    Hanau, 63450
    Germany

    Site Not Available

  • Hannover,
    Germany

    Site Not Available

  • Herne,
    Germany

    Site Not Available

  • Kiel,
    Germany

    Site Not Available

  • Koeln,
    Germany

    Site Not Available

  • Leipzig,
    Germany

    Site Not Available

  • empty

    Leipzig, Saxonia,
    Germany

    Site Not Available

  • Luebeck,
    Germany

    Site Not Available

  • Magdeburg,
    Germany

    Site Not Available

  • St. Hildegardis-Krankenhaus- Katholisches Klinikum Mainz

    Mainz, 55131
    Germany

    Site Not Available

  • Merseburg,
    Germany

    Site Not Available

  • Minden,
    Germany

    Site Not Available

  • München,
    Germany

    Site Not Available

  • LMU Campus Innenstadt

    Mÿnchen, 80336
    Germany

    Site Not Available

  • Paderborn,
    Germany

    Site Not Available

  • Recklinghausen,
    Germany

    Site Not Available

  • Weiden,
    Germany

    Site Not Available

  • Azienda Ospedaliera Istituti Ospitalieri di Cremona

    Cremona, 26100
    Italy

    Site Not Available

  • Ente Ospedaliero Ospedali Galliera

    Genova, 16128
    Italy

    Site Not Available

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100
    Italy

    Site Not Available

  • University of Perugia Hospital

    Perugia, 06129
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, 20089
    Italy

    Site Not Available

  • Azienda Ospedaliera Ospedale Treviglio-Caravaggio di Treviglio

    Treviglio, 24047
    Italy

    Site Not Available

  • Universita dell Insubria

    Varese, 21100
    Italy

    Site Not Available

  • Arkhangelsk,
    Russian Federation

    Site Not Available

  • Chelyabinsk,
    Russian Federation

    Site Not Available

  • Kursk,
    Russian Federation

    Site Not Available

  • Moscow,
    Russian Federation

    Site Not Available

  • Novosibirsk,
    Russian Federation

    Site Not Available

  • Omsk,
    Russian Federation

    Site Not Available

  • Saint Petersburg,
    Russian Federation

    Site Not Available

  • St Petersburg,
    Russian Federation

    Site Not Available

  • Tomsk,
    Russian Federation

    Site Not Available

  • Yaroslavi,
    Russian Federation

    Site Not Available

  • Bournemouth,
    United Kingdom

    Site Not Available

  • Cheltenham,
    United Kingdom

    Site Not Available

  • Dundee,
    United Kingdom

    Site Not Available

  • London,
    United Kingdom

    Site Not Available

  • Manchester,
    United Kingdom

    Site Not Available

  • Plymouth,
    United Kingdom

    Site Not Available

  • Swindon,
    United Kingdom

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Tucson, Arizona
    United States

    Site Not Available

  • Little Rock, Arkansas
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Martinez, California
    United States

    Site Not Available

  • Santa Barbara, California
    United States

    Site Not Available

  • Torrance, California
    United States

    Site Not Available

  • Upland, California
    United States

    Site Not Available

  • Denver, Colorado
    United States

    Site Not Available

  • Helen & Harry Gray Cancer Center-Hartford Hospital

    Hartford, Connecticut 06102
    United States

    Site Not Available

  • Norwich, Connecticut
    United States

    Site Not Available

  • Gainesville, Florida
    United States

    Site Not Available

  • Miami, Florida
    United States

    Site Not Available

  • Miami Shores, Florida
    United States

    Site Not Available

  • New Port Richey, Florida
    United States

    Site Not Available

  • Florida Hospital Tampa

    Tampa, Florida 33613
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Evanston, Illinois
    United States

    Site Not Available

  • Joliet, Illinois
    United States

    Site Not Available

  • Peoria, Illinois
    United States

    Site Not Available

  • Rockford, Illinois
    United States

    Site Not Available

  • Skokie, Illinois
    United States

    Site Not Available

  • Urbana, Illinois
    United States

    Site Not Available

  • Anderson, Indiana
    United States

    Site Not Available

  • Cedar Rapids, Iowa
    United States

    Site Not Available

  • Brewer, Maine
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • Silver Spring, Maryland
    United States

    Site Not Available

  • Boston, Massachusetts
    United States

    Site Not Available

  • Detroit, Michigan
    United States

    Site Not Available

  • Rochester, Minnesota
    United States

    Site Not Available

  • Saint Cloud, Minnesota
    United States

    Site Not Available

  • Coborn Cancer Center

    St. Cloud, Minnesota 56303
    United States

    Site Not Available

  • Kansas City, Missouri
    United States

    Site Not Available

  • Grand Island, Nebraska
    United States

    Site Not Available

  • Las Vegas, Nevada
    United States

    Site Not Available

  • Lebanon, New Hampshire
    United States

    Site Not Available

  • Albany, New York
    United States

    Site Not Available

  • Bronx, New York
    United States

    Site Not Available

  • East Syracuse, New York
    United States

    Site Not Available

  • New York, New York
    United States

    Site Not Available

  • Albert Einstein College Of Medicine

    The Bronx, New York 10467
    United States

    Site Not Available

  • Charlotte, North Carolina
    United States

    Site Not Available

  • High Point, North Carolina
    United States

    Site Not Available

  • Cleveland, Ohio
    United States

    Site Not Available

  • Eugene, Oregon
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Erie, Pennsylvania
    United States

    Site Not Available

  • Charleston, South Carolina
    United States

    Site Not Available

  • Greenville, South Carolina
    United States

    Site Not Available

  • Charleston Cancer Center

    N Charleston, South Carolina 29406
    United States

    Site Not Available

  • North Charleston, South Carolina
    United States

    Site Not Available

  • Rapid City, South Dakota
    United States

    Site Not Available

  • Nashville, Tennessee
    United States

    Site Not Available

  • Abilene, Texas
    United States

    Site Not Available

  • Austin, Texas
    United States

    Site Not Available

  • Beaumont, Texas
    United States

    Site Not Available

  • Bedford, Texas
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Denton, Texas
    United States

    Site Not Available

  • Flower Mound, Texas
    United States

    Site Not Available

  • Garland, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Paris, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

  • Sugar Land, Texas
    United States

    Site Not Available

  • Texas Oncology - Sugarland

    Sugarland, Texas 77479
    United States

    Site Not Available

  • Temple, Texas
    United States

    Site Not Available

  • The Woodlands, Texas
    United States

    Site Not Available

  • Tyler, Texas
    United States

    Site Not Available

  • Waco, Texas
    United States

    Site Not Available

  • Roanoke, Virginia
    United States

    Site Not Available

  • Winchester, Virginia
    United States

    Site Not Available

  • Rockwood Clinic

    Spokane, Washington 99202
    United States

    Site Not Available

  • Green Bay, Wisconsin
    United States

    Site Not Available

  • Weston, Wisconsin
    United States

    Site Not Available

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