BioCentury
ARTICLE | Clinical News

Sapacitabine: Phase III ongoing

November 3, 2014 8:00 AM UTC

Cyclacel said an independent DSMB recommended continuation of the open-label, international Phase III SEAMLESS trial of oral sapacitabine based on available data from 317 patients with >=60 days of follow-up showing no safety or efficacy concerns in its fourth planned safety review. SEAMLESS is comparing 20 mg/m 2 IV decitabine for 5 consecutive days of a 4-week cycle alternating with 300 mg sapacitabine twice daily 3 times a week for 2 weeks of a 4-week cycle vs. decitabine alone in 485 newly diagnosed AML patients ages >=70 years who are unfit for or have refused intensive chemotherapy. Cyclacel has an SPA from FDA for the trial. ...