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Trial record 1 of 1 for:    39039039STM4001
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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 : Completed
First Posted : September 22, 2015
Results First Posted : September 12, 2019
Last Update Posted : September 12, 2019
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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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 Design
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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
Actual Primary Completion Date : August 24, 2018
Actual Study Completion Date : August 24, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Janssen Research & Development, LLC
Bayer
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Statistical Analysis Plan  [PDF] September 5, 2018
Study Protocol  [PDF] February 16, 2018

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02555878    
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
Results First Posted: September 12, 2019
Last Update Posted: September 12, 2019
Last Verified: August 2019

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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:
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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