Efficacy and Safety of Rivaroxaban Prophylaxis Compared with Placebo in Ambulatory Cancer Patients Initiating Systemic Cancer Therapy and at High Risk for Venous Thromboembolism

Janssen-Cilag International N.V.0 个研究点目标入组 800 人开始时间: 2016年1月14日最近更新: 2018年5月21日

适应症

试验速览

暂无简介。

•- 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 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 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

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