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.
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
28
oral administration
National Cancer Center
Gyeonggi-do, South Korea
Yonsei University Health System Severance Hospital
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Duration of Grade 4 neutropenia
Complete blood count and absolute neutrophil count assessed daily to determine febrile neutropenia
Time frame: 15 days after starting chemotherapy
Incidence of Grade 3-4 neutropenia
The grade for Neutropenia is assessed according to NCI CTCAE 4.03 version
Time frame: For 15 days after starting chemotherapy (except Day 3 and 4)
Incidence of febrile neutropenia
Febrile neutropenia is assessed by ANC and body temperature according to NCI CTCAE version 4.03
Time frame: For 15 days after starting chemotherapy (except Day 3 and 4)
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