Nanogen Pegfilgrastim (Pegcyte) PK/PD Clinical Study in Breast Cancer Patients
Status:
Completed
Trial end date:
2017-11-06
Target enrollment:
Participant gender:
Summary
Breast cancer patients scheduled to receive myelosuppressive chemotherapy (AC regimen) will
be enrolled in this study. Eligible patients receive single SC injection of pegcyte or
neulastim 24 hours after administration of chemotherapy (Doxorubicin and Cyclophosphamide) in
the first cycle (14 days each cycle). Blood samples are collected to determine the serum
concentration of investigational drugs at specific time points in the first cycle. Absolute
neutrophil count, CD34+ count, Cmax (maximum serum concentration), AUC0-t (area under the
curve of the plasma concentration time) and Tmax (time required to reach Cmax) will be
calculated from the serum concentration profile
Phase:
Phase 1
Details
Lead Sponsor:
Nanogen Pharmaceutical Biotechnology Joint Stock Company