Edition:
United States

Pfizer And Astellas Amend Clinical Research Protocols For Two Phase 3 Trials Of Enzalutamide


Wednesday, 22 Aug 2018 05:00pm EDT 

Aug 22 (Reuters) - Astellas Pharma Inc <4503.T>::PFIZER AND ASTELLAS AMEND CLINICAL RESEARCH PROTOCOLS FOR TWO PHASE 3 TRIALS OF ENZALUTAMIDE IN PATIENTS WITH HORMONE-SENSITIVE PROSTATE CANCER.PFIZER INC - AMENDMENTS ACCELERATE ANTICIPATED PRIMARY COMPLETION DATES FOR BOTH ARCHES AND EMBARK TRIALS.PFIZER INC - AMENDMENTS TO PROTOCOLS FOR TWO REGISTRATIONAL PHASE 3 TRIALS, ARCHES AND EMBARK.PFIZER INC - CHANGES TO PROTOCOL FOR PHASE 3 ARCHES STUDY INCLUDE REVISION OF PLANNED ANALYSES OF PRIMARY AND SECONDARY ENDPOINTS.PFIZER INC - COS ANTICIPATE PRIMARY COMPLETION DATE FOR ARCHES CLINICAL TRIAL TO BE IN LATE 2018.PFIZER INC - ESTIMATED PRIMARY COMPLETION DATE FOR EMBARK CLINICAL TRIAL IS MID-2020.PFIZER INC - REVISIONS WERE ALSO MADE TO PROTOCOL FOR PHASE 3 EMBARK STUDY.PFIZER - MAIN PURPOSE OF AMENDMENT TO PROTOCOL FOR PHASE 3 EMBARK STUDY IS TO REVISE THE PLANNED ANALYSES OF THE PRIMARY & SEVERAL SECONDARY ENDPOINTS.