Venous Thromboembolism (VTE) 39039039STM4001 (BAY 59-7939)

May 09, 2017

Sponsor: Janssen Research & Development, LLC

Number: 39039039STM4001 (BAY 59-7939)

Eligible patients who enroll in the study will be randomly assigned (by chance) to this multicenter, 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.

Who’s eligible:

  • The patient must have histologically confirmed (tissue microscopically examined) solid malignancy (An abnormal mass of tissue that usually does not contain cysts or liquid areas) including but not limited to: pancreas, lung, stomach, colon, rectum, bladder, breast, ovary, renal or lymphoma (hematologic), with locally advanced or metastatic disease. Metastatic disease  is cancer which has spread from the site of the primary (original) tumor only to surrounding tissue, lymph nodes, or the development of secondary malignant growths at a distance from a primary site of cancer.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 ECOG status is used by your doctor in order to assess how your disease is progressing, assess how the disease effects of your daily living abilities, and determine appropriate treatment and prognosis.
  • 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. An intended duration that is determined by the treating oncologist according to standard protocols of clinical care.
  • This study is for patients age 18 and older.

Available at: Backus Hospital- Eastern Connecticut Hematology and Oncology.

Cancer Clinical Research Office