A Phase II, Randomized, Multi-Centre, Open-Label, Active-Controlled, Dose-Finding Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This is a randomized, multi-center, dose finding, open label, positive controlled Phase II
study of the efficacy and safety of once-per-cycle of F-627 compared with Neulasta®
(pegfilgrastim) in women with breast cancer who are receiving myelotoxic TC chemotherapy
(Taxotere (docetaxel) + cyclophosphamide).
The primary objective of this study is to evaluate the efficacy and safety of various single
cycle doses of F-627 as compared with the standard dosing of Neulasta® (pegfilgrastim) in
breast cancer patients experiencing myelotoxic chemotherapy. Myelotoxicity in this study
will be defined by the duration of moderate neutropenia; the number of days in which the
patient has had an absolute neutrophil count (ANC) < 1.0 × 10^9/L during the first cycle of
their chemotherapy treatment (each chemotherapy cycle is expected to last 21 days). This, by
definition, includes grade 3 (moderate) and grade 4 (severe) neutropenia. Doses of F-627 to
be tested are 80 µg/kg/dose, 240 µg/kg/dose, and 320 µg/kg/dose.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The efficacy and safety of various single cycle doses of F-627 to measure the duration of moderate neutropenia post Chemotherapy administration as compared with the standard dosing of Neulasta
After randomization, The subject's ANC value will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0 x 10^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered.
The first of 4, 21 Day Chemotherapy Cycles
United States: Food and Drug Administration
|Community Hospital of Anderson||Anderson, Indiana|