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news.Daiichi Sankyo has started a multinational study called Hokusai-VTE Cancer to evaluate the efficacy and safety of edoxaban, an oral, once-daily selective factor Xa inhibitor, versus dalteparin to treat Venous Thromboembolism (VTE).
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The trial is designed to assess the role of edoxaban in VTE patients 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.
In the trial, edoxaban will be evaluated 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.
Patient enrollment has already been initiated and around 1,000 people are expected to be included in the trial at clinical sites across 13 countries in North America, Europe, Australia and New Zealand.
University of Oklahoma Health Sciences Center College of Public Health and Regents professor, Epidemiology and Medicine Dean Gary Raskob 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% 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 four- to seven-fold risk of developing VTE.
"This trial will allow us to gain further understanding of the efficacy and safety of edoxaban in comparison to current standards of care for these patients."
Objectives of the multinational, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) Hokusai-VTE Cancer study include evaluating 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.
During the trial, patients will be randomized to receive edoxaban 60mg once-daily, following treatment with LMWH for at least five days; or dalteparin SC 200IU/kg once-daily for 30 days, then 150IU/kg once-daily for the remaining of the 12-month study.
Currently, edoxaban is marketed in Japan, the US, and Switzerland, and has also been recommended for approval in the EU by the European Committee for Medicinal Products for Human Use (CHMP).
Image: Daiichi Sankyo’s Hokusai-VTE Cancer study will evaluate the efficacy and safety of edoxaban versus dalteparin in VTE patients associated with cancer. Photo: courtesy of Michelle Meiklejohn/ freedigitalphotos.net.