Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer
brief summary
To assess the safety and establish the dose to assess the pharmacokinetic activity following administration of EC-18 in patients with advanced breast cancer receiving low febrile neutropenia risk chemotherapy who are the candidates for second-line or higher combination therapy with doxorubicin and cyclophosphamide.
detailed description
This study will utilize a non-randomized, open-label 3 + 3 dose escalation design in which subjects will receive 500 mg, 1000 mg, 1500 mg, 2000 mg, 3000 mg and 4000mg of EC-18. The stepwise daily dosing by cohort was performed for 21 days (3 weeks)
official title
EC-18 for Management of Chemotherapy-Induced Neutropenia in Patients With Advanced BC Receiving Low Febrile Neutropenia Risk Chemotherapy: Dose-Escalation, Open-label, Trial to Assess Safety and Tolerability of EC-18