Overview

A Phase II, Dose-finding Study of F-627 in Patients With Breast Cancer Receiving Myelotoxic Chemotherapy.

Status:
Recruiting
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
Summary
This was a randomized, open-label, active-controlled, dose-finding, phase II study to evaluate the efficacy and safety of 2 doses of F-627 compared to Filgrastim in women with breast cancer receiving myelotoxic chemotherapy. Subjects would be randomized to one of three arms, which were 10 mg/dose of F-627, 20 mg/dose of F-627 or Filgrastim, in an equal ratio.
Phase:
Phase 2
Details
Lead Sponsor:
Generon (Shanghai) Corporation Ltd.
Collaborators:
Affiliated Tumor Hospital of Guangzhou Medical University
Fudan University
Nanfang Hospital of Southern Medical University
Qingdao University
RenJi Hospital
The Affiliated Tumor Hospital of Nantong University, Nantong, Jiangsu Province, China
Tongji Hospital
Treatments:
Cyclophosphamide
Epirubicin
Lenograstim