Date: 2015-05-28
Type of
information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Bayer Healthcare (Germany) Janssen Pharmaceuticals, a J&J company (USA - NJ)
Product: Xarelto® (rivaroxaban)
Action
mechanism: anticoagulant agent/oral direct Factor Xa inhibitor
Disease: prevention and treatment of pulmonary embolism and deep vein thrombosis in patients with various types of cancer
Therapeutic
area: Cancer - Oncology - Cardiovascular diseases
Country:
Trial
details:
- The CALLISTO Programme is a multi-trial prospective clinical research initiative aimed at generating new evidence to help manage cancer-associated thrombosis (CAT). The Programme will consist of nine initiatives in total, comprising both clinical studies and Registries, and will involve more than 4,000 patients worldwide. Three additional studies will focus on important clinical aspects such as enhancing the clinical knowledge on rivaroxaban treatment in patients with cancer receiving standard cancer therapies, e.g. chemotherapy, and the assessment of a bridging strategy between rivaroxaban and low-molecular-weight heparin in instances where chemotherapy-induced vomiting makes oral therapy challenging
Latest
news:
- • On May 28, 2015, Bayer HealthCare and its development partner Janssen Pharmaceuticals announced the initiation of the CALLISTO Clinical Research Programme to explore the potential benefits of the oral Factor Xa inhibitor Xarelto® (rivaroxaban) for the prevention and treatment of pulmonary embolism and deep vein thrombosis in patients with various types of cancer. In patients with active cancer, the risk of VTE is four to seven times higher than in people of the same age without cancer. And importantly, chemotherapy significantly increases the risk further by up to 6.5 times. Despite this, none of the current Clinical Guidelines recommend the routine use of VTE prevention in most ambulatory cancer patients. Regarding the use of anticoagulation therapy for the treatment and secondary prevention of VTE, current Clinical Guideline recommendations are based on few and small clinical trials. The CALLISTO Programme is a multi-trial prospective clinical research initiative aimed at generating new evidence to help manage cancer-associated thrombosis (CAT). The Programme will consist of nine initiatives in total, comprising both clinical studies and Registries, and will involve more than 4,000 patients worldwide. CALLISTO addresses three key areas of cancer-associated thrombosis:
- • Prevention of VTE
- Evaluation of rivaroxaban in comparison to placebo for the prevention of pulmonary embolism and deep vein thrombosis in patients at high risk of blood clots undergoing chemotherapy for different forms of cancer
- • Treatment and Secondary Prevention of VTE
- A series of five initiatives (three clinical studies and two Registries) will assess rivaroxaban for the treatment and secondary prevention of pulmonary embolism and deep vein thrombosis in patients with active cancer
- • Important Clinical Aspects
- Three additional studies will focus on important clinical aspects such as enhancing the clinical knowledge on rivaroxaban treatment in patients with cancer receiving standard cancer therapies, e.g. chemotherapy, and the assessment of a bridging strategy between rivaroxaban and low-molecular-weight heparin in instances where chemotherapy-induced vomiting makes oral therapy challenging
- The CALLISTO Clinical Research Programme will add to the overall investigation of rivaroxaban, which - by the time of its completion - is expected to include more than 275,000 patients in both clinical trials and real world settings.
Is
general: Yes
