15
Participants
Start Date
February 25, 2014
Primary Completion Date
August 19, 2015
Study Completion Date
August 19, 2015
F-627 240 μg/kg
F-627 at 240 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle(21 days) of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 240 μg/kg arm. And the arm should contain 6 evaluable subjects.
F-627 320 μg/kg
F-627 at 320 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle(21 days) of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 320 μg/kg arm. The arm should contain 6 evaluable subjects.
Fudan University Shanghai Cancer Center, Shanghai
Lead Sponsor
Fudan University
OTHER
Sun Yat-sen University
OTHER
EVIVE Biotechnology
INDUSTRY