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NeoplasmsPhase 3NCT02555878

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

A Phase 3 study testing Rivaroxaban in people with Neoplasms, run by Janssen Research & Development, LLC at 151 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Neoplasms
What is being tested?
Rivaroxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
841 participants
Where
151 sitesin 10 countries
Study dates
11 Sep 2015to 24 Aug 2018
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

151 sites in 10 countries.

151 sites in 10 countries

United States70 sites

  • Study site

    Abilene, Texas

  • Study site

    Albany, New York

  • Study site

    Anderson, Indiana

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Beaumont, Texas

  • Study site

    Bedford, Texas

  • Study site

    Boston, Massachusetts

  • Study site

    Brewer, Maine

  • Study site

    Cedar Rapids, Iowa

  • Study site

    Charleston, South Carolina

  • Study site

    Charlotte, North Carolina

  • Study site

    Cleveland, Ohio

  • Study site

    Dallas, Texas

  • Study site

    Denton, Texas

  • Study site

    Denver, Colorado

  • Study site

    Detroit, Michigan

  • Study site

    East Syracuse, New York

  • Study site

    Erie, Pennsylvania

  • Study site

    Eugene, Oregon

  • Study site

    Evanston, Illinois

  • Study site

    Flower Mound, Texas

  • Study site

    Gainesville, Florida

  • Study site

    Garland, Texas

  • Study site

    Grand Island, Nebraska

  • Study site

    Green Bay, Wisconsin

  • Study site

    Greenville, South Carolina

  • Study site

    High Point, North Carolina

  • Study site

    Houston, Texas

  • Study site

    Joliet, Illinois

  • Study site

    Kansas City, Missouri

  • Study site

    Las Vegas, Nevada

  • Study site

    Lebanon, New Hampshire

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Martinez, California

  • Study site

    Miami, Florida

  • Study site

    Miami Shores, Florida

  • Study site

    Nashville, Tennessee

  • Study site

    New Port Richey, Florida

  • Study site

    New York, New York

  • Study site

    North Charleston, South Carolina

  • Study site

    Norwich, Connecticut

  • Study site

    Paris, Texas

  • Study site

    Peoria, Illinois

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Rapid City, South Dakota

  • Study site

    Roanoke, Virginia

  • Study site

    Rochester, Minnesota

  • Study site

    Rochester, New York

  • Study site

    Rockford, Illinois

  • Study site

    Saint Cloud, Minnesota

  • Study site

    San Antonio, Texas

  • Study site

    Santa Barbara, California

  • Study site

    Silver Spring, Maryland

  • Study site

    Skokie, Illinois

  • Study site

    Sugar Land, Texas

  • Study site

    Temple, Texas

  • Study site

    The Bronx, New York

  • Study site

    The Woodlands, Texas

  • Study site

    Torrance, California

  • Study site

    Tucson, Arizona

  • Study site

    Tyler, Texas

  • Study site

    Upland, California

  • Study site

    Urbana, Illinois

  • Study site

    Waco, Texas

  • Study site

    Weston, Wisconsin

  • Study site

    Winchester, Virginia

Other trials in United States

Germany20 sites

  • Study site

    Berlin

  • Study site

    Brandenburg

  • Study site

    Cologne

  • Study site

    Dortmund

  • Study site

    Dresden

  • Study site

    Esslingen am Neckar

  • Study site

    Gauting

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Herne

  • Study site

    Kiel

  • Study site

    Leipzig

  • Study site

    Lübeck

  • Study site

    Magdeburg

  • Study site

    Merseburg

  • Study site

    Minden

  • Study site

    München

  • Study site

    Paderborn

  • Study site

    Recklinghausen

  • Study site

    Weiden

Other trials in Germany

Brazil14 sites

  • Study site

    Barretos

  • Study site

    Caxias do Sul

  • Study site

    Curitiba

  • Study site

    Itajaí

  • Study site

    Lajeado

  • Study site

    Londrina

  • Study site

    Mogi das Cruzes

  • Study site

    Porto Alegre

  • Study site

    Porto Alegre, Rs

  • Study site

    Rio de Janeiro

  • Study site

    Santo André

  • Study site

    São José do Rio Preto

  • Study site

    São Paulo

  • Study site

    Sorocaba

Other trials in Brazil

Czechia10 sites

  • Study site

    Benešov nad Černou

  • Study site

    Brno

  • Study site

    Jindřichův Hradec

  • Study site

    Kladno

  • Study site

    Liberec

  • Study site

    Nový Jičín

  • Study site

    Olomouc

  • Study site

    Pardubice

  • Study site

    Prague

  • Study site

    Tábor

Other trials in Czechia

France9 sites

  • Study site

    Angers

  • Study site

    Avignon

  • Study site

    Dijon

  • Study site

    Hyers

  • Study site

    Le Mans

  • Study site

    Paris

  • Study site

    Rennes

  • Study site

    Saint-Herblain

  • Study site

    Valenciennes

Other trials in France

Russia9 sites

  • Study site

    Arkhangelsk

  • Study site

    Chelyabinsk

  • Study site

    Kursk

  • Study site

    Moscow

  • Study site

    Novosibirsk

  • Study site

    Omsk

  • Study site

    Saint Petersburg

  • Study site

    Tomsk

  • Study site

    Yaroslavi

Other trials in Russia

Belgium7 sites

  • Study site

    Amberloup

  • Study site

    Bonheiden

  • Study site

    Brussels

  • Study site

    Edegem

  • Study site

    Laken (brussel)

  • Study site

    Turnhout

  • Study site

    Wilrijk

Other trials in Belgium

United Kingdom7 sites

  • Study site

    Bournemouth

  • Study site

    Cheltenham

  • Study site

    Dundee

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Plymouth

  • Study site

    Swindon

Other trials in United Kingdom

Canada3 sites

  • Study site

    Québec

  • Study site

    Saint-Jérôme, Quebec

  • Study site

    Toronto, Ontario

Other trials in Canada

Bulgaria2 sites

  • Study site

    Plovdiv

  • Study site

    Sofia

Other trials in Bulgaria

About this study

Official title: 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.

Read the 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.

Conditions
Neoplasms
Being tested
Rivaroxaban, Placebo
Keywords
Cancer, Rivaroxaban, Venous thromboembolism
Medical subject headings
Neoplasms, Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RivaroxabanDrug

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

  • PlaceboDrug

    Placebo tablet will be administered orally once daily for 180 days.

Study groups in NCT02555878
Study groupRoleWhat they receive
RivaroxabanExperimentalParticipants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Receives: Drug: Rivaroxaban
PlaceboExperimentalParticipants will be administered matching placebo tablet orally once daily for 180 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)

    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).

    Measured: Up to Day 180

  2. Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)

    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.

    Measured: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Secondary outcomes (11)

  1. Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths

    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.

    Measured: Up to Day 180

  2. Percentage of Participants With All-Cause Mortality

    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.

    Measured: Up to Day 180

  3. Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)

    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.

    Measured: Up to Day 180

  4. Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE

    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.

    Measured: Up to Day 180

  5. Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1

    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.

    Measured: Up to Day 180

  6. Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2

    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.

    Measured: Up to Day 180

  7. Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3

    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.

    Measured: Up to Day 180

  8. Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4

    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.

    Measured: Up to Day 180

  9. Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding

    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.

    Measured: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

  10. Percentage of Participants With Time to the First Occurrence of Minor Bleeding

    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.

    Measured: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

  11. Percentage of Participants With Time to the First Occurrence of Any Bleeding

    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.

    Measured: From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2015 (estimated)
  2. Study start11 Sep 2015
  3. Primary completion24 Aug 2018
  4. Study completion24 Aug 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
841 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02555878
Sponsor's protocol ID
CR107047
Other IDs
39039039STM4001, 2015-001630-21, 2015
Status last verified
Aug 2019
First submitted
18 Sep 2015
Last updated
12 Sep 2019
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Khorana AA, Barnard J, Wun T, Vijapurkar U, Damaraju CV, Moore KT, Wildgoose P, McCrae KR. Biomarker signatures in cancer patients with and without venous thromboembolism events: a substudy of CASSINI. Blood Adv. 2022 Feb 22;6(4):1212-1221. doi: 10.1182/bloodadvances.2021005710.

    PubMed 34807979

  • Rutjes AW, Porreca E, Candeloro M, Valeriani E, Di Nisio M. Primary prophylaxis for venous thromboembolism in ambulatory cancer patients receiving chemotherapy. Cochrane Database Syst Rev. 2020 Dec 18;12(12):CD008500. doi: 10.1002/14651858.CD008500.pub5.

    PubMed 33337539

  • Vadhan-Raj S, McNamara MG, Venerito M, Riess H, O'Reilly EM, Overman MJ, Zhou X, Vijapurkar U, Kaul S, Wildgoose P, Khorana AA. Rivaroxaban thromboprophylaxis in ambulatory patients with pancreatic cancer: Results from a pre-specified subgroup analysis of the randomized CASSINI study. Cancer Med. 2020 Sep;9(17):6196-6204. doi: 10.1002/cam4.3269. Epub 2020 Jul 14.

    PubMed 32663379

  • Khorana AA, Soff GA, Kakkar AK, Vadhan-Raj S, Riess H, Wun T, Streiff MB, Garcia DA, Liebman HA, Belani CP, O'Reilly EM, Patel JN, Yimer HA, Wildgoose P, Burton P, Vijapurkar U, Kaul S, Eikelboom J, McBane R, Bauer KA, Kuderer NM, Lyman GH; CASSINI Investigators. Rivaroxaban for Thromboprophylaxis in High-Risk Ambulatory Patients with Cancer. N Engl J Med. 2019 Feb 21;380(8):720-728. doi: 10.1056/NEJMoa1814630.

    PubMed 30786186

  • Khorana AA, Vadhan-Raj S, Kuderer NM, Wun T, Liebman H, Soff G, Belani C, O'Reilly EM, McBane R, Eikelboom J, Damaraju CV, Beyers K, Dietrich F, Kakkar AK, Riess H, Peixoto RD, Lyman GH. Rivaroxaban for Preventing Venous Thromboembolism in High-Risk Ambulatory Patients with Cancer: Rationale and Design of the CASSINI Trial. Rationale and Design of the CASSINI Trial. Thromb Haemost. 2017 Nov 1;117(11):2135-2145. doi: 10.1160/TH17-03-0171. Epub 2017 Sep 21.

    PubMed 28933799

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rivaroxaban in people with Neoplasms, run by Janssen Research & Development, LLC at 151 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Germany, Brazil, Czechia, France and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components) (time frame: Up to Day 180). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02555878, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2019.

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Clinical Trial NCT02555878 | AzTrials