SHANGHAI--(BUSINESS WIRE)--Generon (Shanghai) Corporation Ltd. today announced the initiation of a Phase II clinical trial for F-627 after US FDA regulatory clearance. The current study is a Phase II, 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. The clinical trial 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.
