Date: 2015-06-18
Type of information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Daiichi Sankyo (Japan)
Product: edoxaban
Action
mechanism: blood coagulation factor XA inhibitor/antithrombotic. Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting. The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation). The results from these trials form the basis of the MAA for edoxaban for the prevention of stroke and SEE in patients with NVAF, as well as for the treatment of DVT or PE and prevention of recurrence of symptomatic VTE.
Disease: venous thromboembolism (VTE) associated with cancer
Therapeutic area: Cancer - Oncology - Cardiovascular diseases
Country:
Trial
details: Hokusai-VTE Cancer is 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.
Latest
news: * On June 18, 2015, Daiichi Sankyo announced the initiation of Hokusai-VTE Cancer, a multinational study 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. The purpose of the study is to evaluate edoxaban in comparison with dalteparin in preventing the combined outcome of VTE recurrence or major bleeding following an acute deep vein thrombosis (DVT) or
pulmonary embolism (PE) event in patients with cancer. The recruitment has started, and approximately 1,000 patients are expected to be enrolled in the study at clinical sites across 13 countries.
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). In other countries, regulatory review is ongoing.
