Overview

A Pharmacokinetics/Dynamics Ib Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Status:
Recruiting
Trial end date:
0000-00-00
Target enrollment:
Participant gender:
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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Generon (Shanghai) Corporation Ltd.
Collaborators:
Fudan University
Sun Yat-sen University
Treatments:
Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin