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

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ClinicalTrials.gov Identifier: NCT02555878
Recruitment Status : Active, not recruiting
First Posted : September 22, 2015
Last Update Posted : June 4, 2018
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Research & Development, LLC

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.

Condition or disease Intervention/treatment Phase
Neoplasms Drug: Rivaroxaban Drug: Placebo Phase 3

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 : Interventional  (Clinical Trial)
Actual Enrollment : 841 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : September 11, 2015
Estimated Primary Completion Date : July 13, 2018
Estimated Study Completion Date : August 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Time From Randomization 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,VTE-Related Death [ Time Frame: From Randomization to the Day 180 visit as Adjudicated by an Independent blinded CEC ]
    Diagnosis of DVT confirmed by compression ultrasonography and diagnosis of PE through computerized tomography or ventilation/perfusion lung scan.

  2. The Primary Safety Endpoint is the Major Bleeding Events as Defined by ISTH [ Time Frame: From the Time of Randomization to 2 Days After the Last Dose of Study Drug ]

    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, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or death.



Secondary Outcome Measures :
  1. The Key Secondary Efficacy Endpoints Include the Following: 1) Symptomatic VTE Events (DVT/PE) and VTE-Related Deaths and 2) All-cause Mortality [ Time Frame: From the time of randomization to the Day 180 visit ]
  2. Secondary 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 as defined by ISTH) [ Time Frame: From the Time of Randomization to Two Days After the Last Dose of Study Drug ]
    According to International Society on Thrombosis & Haemostasis (ISTH) definition.

  3. Number of Participants with Adverse Events (AEs) and Serious AEs [ Time Frame: Screening up to follow-up (30 days after last dose administration) ]
    Adverse events or serious adverse events will be collected and entered into the eCRF. All SAEs that are not outcome events occurring during the study must be reported to the appropriate sponsor contact person by study-site personnel within 24 hours of their knowledge of the event.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555878


  Show 158 Study Locations
Sponsors and Collaborators
Janssen Research & Development, LLC
Bayer
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02555878     History of Changes
Other Study ID Numbers: CR107047
39039039STM4001 ( Other Identifier: Janssen Research & Development, LLC )
2015-001630-21 ( EudraCT Number )
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Janssen Research & Development, LLC:
Cancer
Rivaroxaban
Venous thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Rivaroxaban
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants