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Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

Febrile Neutropenia Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03104595
Study type Interventional
Source Enzychem Lifesciences Corporation
Contact
Status Completed
Phase Phase 1/Phase 2
Start date October 30, 2017
Completion date December 5, 2019
View Details
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