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
3 other identifiers
interventional
841
10 countries
151
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2015
Typical duration for phase_3
151 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 11, 2015
CompletedFirst Submitted
Initial submission to the registry
September 18, 2015
CompletedFirst Posted
Study publicly available on registry
September 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2018
CompletedResults Posted
Study results publicly available
September 12, 2019
CompletedSeptember 12, 2019
August 1, 2019
3 years
September 18, 2015
August 22, 2019
August 22, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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).
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)
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 Outcomes (11)
Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths
Up to Day 180
Percentage of Participants With All-Cause Mortality
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE
Up to Day 180
Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1
Up to Day 180
- +6 more secondary outcomes
Study Arms (2)
Rivaroxaban
EXPERIMENTALParticipants will be administered rivaroxaban 10 milligram (mg) tablet orally once daily for 180 days.
Placebo
EXPERIMENTALParticipants will be administered matching placebo tablet orally once daily for 180 days.
Interventions
Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Bayercollaborator
Study Sites (151)
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Los Angeles, California, United States
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Martinez, California, United States
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Santa Barbara, California, United States
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Torrance, California, United States
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Upland, California, United States
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Denver, Colorado, United States
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Norwich, Connecticut, United States
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Gainesville, Florida, United States
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Miami, Florida, United States
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Miami Shores, Florida, United States
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New Port Richey, Florida, United States
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Atlanta, Georgia, United States
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Evanston, Illinois, United States
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Joliet, Illinois, United States
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Peoria, Illinois, United States
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Rockford, Illinois, United States
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Skokie, Illinois, United States
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Urbana, Illinois, United States
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Anderson, Indiana, United States
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Cedar Rapids, Iowa, United States
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Brewer, Maine, United States
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Baltimore, Maryland, United States
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Silver Spring, Maryland, United States
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Boston, Massachusetts, United States
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Detroit, Michigan, United States
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Rochester, Minnesota, United States
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Saint Cloud, Minnesota, United States
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Kansas City, Missouri, United States
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Grand Island, Nebraska, United States
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Las Vegas, Nevada, United States
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Lebanon, New Hampshire, United States
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Albany, New York, United States
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East Syracuse, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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The Bronx, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Cleveland, Ohio, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Erie, Pennsylvania, United States
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Charleston, South Carolina, United States
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Greenville, South Carolina, United States
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North Charleston, South Carolina, United States
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Rapid City, South Dakota, United States
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Nashville, Tennessee, United States
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Abilene, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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Flower Mound, Texas, United States
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Garland, Texas, United States
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Houston, Texas, United States
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Paris, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Temple, Texas, United States
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The Woodlands, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Roanoke, Virginia, United States
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Winchester, Virginia, United States
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Green Bay, Wisconsin, United States
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Weston, Wisconsin, United States
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Amberloup, Belgium
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Bonheiden, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Laken (brussel), Belgium
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Turnhout, Belgium
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Wilrijk, Belgium
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Barretos, Brazil
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Caxias do Sul, Brazil
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Curitiba, Brazil
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Itajaí, Brazil
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Lajeado, Brazil
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Londrina, Brazil
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Mogi das Cruzes, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Rs, Brazil
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Rio de Janeiro, Brazil
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Santo André, Brazil
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São José do Rio Preto, Brazil
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São Paulo, Brazil
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Sorocaba, Brazil
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Toronto, Ontario, Canada
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Saint-Jérôme, Quebec, Canada
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Québec, Canada
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Benešov nad Černou, Czechia
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Brno, Czechia
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Jindřichův Hradec, Czechia
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Kladno, Czechia
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Liberec, Czechia
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Nový Jičín, Czechia
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Olomouc, Czechia
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Pardubice, Czechia
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Prague, Czechia
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Tábor, Czechia
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Angers, France
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Avignon, France
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Dijon, France
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Hyers, France
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Le Mans, France
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Paris, France
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Rennes, France
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Saint-Herblain, France
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Valenciennes, France
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Berlin, Germany
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Brandenburg, Germany
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Cologne, Germany
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Dortmund, Germany
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Dresden, Germany
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Esslingen am Neckar, Germany
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Gauting, Germany
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Hamburg, Germany
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Hanover, Germany
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Herne, Germany
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Kiel, Germany
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Leipzig, Germany
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Lübeck, Germany
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Magdeburg, Germany
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Merseburg, Germany
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Minden, Germany
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München, Germany
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Paderborn, Germany
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Recklinghausen, Germany
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Weiden, Germany
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Arkhangelsk, Russia
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Chelyabinsk, Russia
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Kursk, Russia
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Moscow, Russia
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Novosibirsk, Russia
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Omsk, Russia
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Saint Petersburg, Russia
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Tomsk, Russia
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Yaroslavi, Russia
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Bournemouth, United Kingdom
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Cheltenham, United Kingdom
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Dundee, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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Plymouth, United Kingdom
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Swindon, United Kingdom
Related Publications (5)
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.
PMID: 34807979DERIVEDRutjes 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.
PMID: 33337539DERIVEDVadhan-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.
PMID: 32663379DERIVEDKhorana 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.
PMID: 30786186DERIVEDKhorana 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.
PMID: 28933799DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Leader
- Organization
- Janssen Scientific Affairs, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 18, 2015
First Posted
September 22, 2015
Study Start
September 11, 2015
Primary Completion
August 24, 2018
Study Completion
August 24, 2018
Last Updated
September 12, 2019
Results First Posted
September 12, 2019
Record last verified: 2019-08