A Study to Evaluate the Efficacy and Safety of Rivaroxaban Venous Thromboembolism (VTE) Prophylaxis in Ambulatory Cancer Participants
- Conditions
- Venous thromboembolism (VTE)MedDRA version: 19.0 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2015-001630-21-GB
- Lead Sponsor
- Janssen-Cilag International N.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 841
- 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 02
- 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 +/- 1 week of receiving the first dose of study drug with the intent of receiving systemic cancer therapy during the double-blind treatment period with for an intended duration determined by the treating oncologist according to standard protocols of clinical care.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 560
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 140
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method