Drug news
F 627 (Generon) commences Phase II study for Neutropenia
A Phase II clinical trial for F 627,recombinant G-CSF from Generon(Shanghai)Corporation, has been started after FDA regulatory clearance. The study is a randomized, multicenter, open-label, active-controlled trial of F 627 in women with Breast Cancer receiving myelotoxic chemotherapy. The clinical trial will enroll approximately 200 patients and will be conducted at approximately 35 clinical centers in North America and Europe. The primary objective of this study is to evaluate the efficacy and safety of various once-per-cycle dosing of F 627 as compared with the standard dosing of Neulasta (pegfilgrastim) in Breast Cancer patients undergoing myelotoxic chemotherapy
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