NCT02527746

Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

A Single-Center, Open-Label, Dose-Escalation Phase I Clinical Trial of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein for Injection as an Adjuvant to Chemotherapy in Subjects With Breast Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: EVIVE Biotechnology · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.

Detailed description

A Phase I, dose escalation study to evaluate the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients receiving 4 cycles of EC (Epirubicin plus Cyclophosphamide) chemotherapy. 18 patients (6 patients each cohort) were assigned to three sequential doses cohort of F-627 at the dose of 80, 240 and 320 µg/kg. The patients received chemotherapy (100 mg/m\^2 epirubicin and 600 mg/m\^2 cyclophosphamide) administrated by i.v. injection on Day 1 and F-627 by s.c. injection on Day 3 of each cycle for 4 cycles. If no dose-limiting toxicity (DLT) was observed in 6 patients during first cycle, the next cohort was escalated. Blood samples were collected for completed blood counts with differential, serum F-627 concentration and safety evaluation at different point following F-672 injection. The decision to proceed to the next higher dose was made jointly by the sponsor's medical expert and the investigator based upon the review of safety data in the first cycle treatment.

Conditions

• Neutropenia
• Breast Cancer

Interventions

Type	Name	Description
DRUG	F-627	F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used.
DRUG	EC regimen	Epirubicin 100 mg/m\^2 (in vein) and Cyclophosphamide 600 mg/m\^2 (in vein) on Day 1 of each cycle for 4 cycles.

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2015-08-19
• Last updated: 2024-02-23
• Results posted: 2024-02-23