A new multinational study is to evaluate edoxaban in comparison with dalteparin in preventing the combined outcome of venous thromboembolism (VTE) recurrence or major bleeding following an acute deep vein thrombosis (DVT) or pulmonary embolism (PE) event in patients with cancer.
Daiichi Sankyo has announced the initiation of the Hokusai-VTE Cancer, which will investigate the efficacy and safety of edoxaban, an oral, once-daily selective factor Xa inhibitor, versus dalteparin for the treatment of VTE associated with cancer (other than basal-cell or squamous-cell carcinoma of the skin) for whom long-term treatment with a low molecular weight heparin (LMWH) is intended.
Commenting on the study Professor Gary Raskob of the University of Oklahoma Health Sciences Center said: "VTE is a major cause of morbidity and mortality in patients with cancer, with an annual incidence that can be as high as 20 percent depending on the cancer type, background risk and time since diagnosis. Compared to those without cancer, patients with cancer who receive chemotherapy treatment have a 4- to 7-fold risk of developing VTE."
Edoxaban is currently marketed in Japan, the U.S., and Switzerland, and has also been recommended for approval in the EU by the European Committee for Medicinal Products for Human Use (CHMP).
Hokusai-VTE Cancer will be a multinational, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) study, evaluating the efficacy and safety of once-daily edoxaban compared to dalteparin for the treatment of VTE associated with cancer. The purpose of the study is to evaluate edoxaban in comparison with dalteparin in preventing the combined outcome of VTE recurrence or major bleeding in patients with VTE associated with cancer.
Other objectives include assessing the effects of treatment on VTE recurrence, clinically relevant bleeding and event-free survival, defined as the proportion of subjects over time free of recurrent VTE, major bleeding events and death. Approximately 1,000 patients are expected to be enrolled across 13 countries in North America, Europe, Australia and New Zealand. Patients will be randomized to receive edoxaban 60 mg once-daily (reduced to 30 mg edoxaban for patients with creatinine clearance [CrCL] 30-50 mL/min, body weight ≤ 60 kg, or concomitant use of P-glycoprotein [P-gp] inhibitors), following treatment with LMWH for at least five days; or dalteparin SC 200 IU/kg once-daily for 30 days, then 150 IU/kg once-daily for the remainder of the 12-month study.
For more information please visit: https://www.clinicaltrials.gov/ct2/show/NCT02073682.