A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
Condition: Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): F-627 240 μg/kg; F-627 320 μg/kg
Intervention type(s): Biological; Biological
Intervention description(s): 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 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.
Other intervention name(s): rh G-CSF Fc Fusion Protein; rh G-CSF Fc Fusion Protein
Intervention MeSH terms: Lenograstim
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neutropenia; Chemotherapy