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.
Brief Title
A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
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.
Completion Date
Completion Date Type
Actual
Conditions
Neoplasms
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Cancer
Rivaroxaban
Venous thromboembolism
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02555878
Org Class
Industry
Org Full Name
Janssen Research & Development, LLC
Org Study Id
CR107047
Overall Status
Completed
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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).
Outcome Measure
Percentage of Participants With Time to First Occurrence of Primary Efficacy Endpoint (Composite and Components)
Outcome Time Frame
Up to Day 180
Outcome Description
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.
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Major Bleeding Events as Defined by International Society of Thrombosis and Haemostasis (ISTH)
Outcome Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Secondary Ids
Secondary Id
39039039STM4001
Secondary Id
2015-001630-21
Secondary Outcomes
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Symptomatic VTE Events or VTE-Related Deaths
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With All-Cause Mortality
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Arterial Thromboembolic Events (ATE)
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Fatal or Non-fatal Visceral VTE
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Composite Efficacy Endpoint 1
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 2
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 3
Outcome Description
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.
Outcome Time Frame
Up to Day 180
Outcome Measure
Percentage of Participants With Time to First Occurrence of Composite Efficacy Endpoint 4
Outcome Description
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.
Outcome Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Clinically Relevant Non-major Bleeding
Outcome Description
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.
Outcome Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Minor Bleeding
Outcome Description
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.
Outcome Time Frame
From first dose of study drug to 2 days after the last dose of the study drug (up to 32 weeks)
Outcome Measure
Percentage of Participants With Time to the First Occurrence of Any Bleeding
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Henny Billett
Investigator Email
hbillett@montefiore.org
Investigator Phone
718-920-6310
Categories Mesh Debug
Cancer --- NEOPLASMS
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
MeSH Terms
NEOPLASMS
VENOUS THROMBOEMBOLISM
THROMBOEMBOLISM
EMBOLISM AND THROMBOSIS
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
RIVAROXABAN
COUNTERFEIT DRUGS
THIOPHENES
SULFUR COMPOUNDS
ORGANIC CHEMICALS
MORPHOLINES
OXAZINES
HETEROCYCLIC COMPOUNDS, 1-RING
HETEROCYCLIC COMPOUNDS
SUBSTANDARD DRUGS
PHARMACEUTICAL PREPARATIONS