At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 18 enrolled
Drug / intervention
F-627 +1 moredrug
Likely dose
EC regimen 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
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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
In Brief
A Phase 1 clinical trial evaluating F-627 and EC regimen for Neutropenia and Breast Cancer. Completed, enrolled 18 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeutropenia, Breast Cancer
Countries--
CollaboratorsFudan University
Timeline
Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2012
Primary CompletionDec 2013
First PostedAug 2015
TodayJul 2026
First PostedAug 19, 2015
Enrollment StartDec 1, 2012
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 10.9 years ago
Interventions
F-627drug
F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used.
EC regimendrug
Epirubicin 100 mg/m\^2 (in vein) and Cyclophosphamide 600 mg/m\^2 (in vein) on Day 1 of each cycle for 4 cycles.