Neutropenia Clinical Trial
Official title:
A Phase Ib Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of F-627 as Prophylaxis Therapy to TAC Chemotherapy in Women With Breast Cancer
This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627
once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.
The patients received the intravenous administration of the chemotherapy (docetaxol,
doxorubicin and cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and
the subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24
hours after chemotherapy) each cycle for up to 6 cycles.
This study was a phase Ib study of the safety and pharmacokinetics/pharmacodynamics of F-627
once per cycle as prophylaxis therapy to chemotherapy in women with breast cancer.
This study was conducted at two centers in China and enrolled 15 patients with breast cancer
receiving TAC chemotherapy (docetaxel, doxorubicin and cyclophosphamide). The patients
received the intravenous administration of the chemotherapy (docetaxol, doxorubicin and
cyclophosphamide, 75 mg/m2, 50 mg/m2 and 500 mg/m2 respectively) on Day 1 and the
subcutaneous injection of F-627 at 240 µg/kg and 320 µg/kg on Day 2 (approximately 24 hours
after chemotherapy) each cycle for up to 6 cycles. Patients will remain on study drug dose
for each of the following 6 chemotherapy cycles.
Patients will remain on study drug dose for each of the following 6 chemotherapy cycles. The
blood sampling will be collected for F-627 serum concentration analysis in cycle of 1 and 3.
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