Clinical Trial: Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: EC-18 for Management of Chemotherapy-Induced Neutropenia in Patients With Advanced BC Receiving Low Febrile Neutropenia Risk Chemotherapy: Dos

Brief Summary: This study will assess treatment of febrile neutropenia in subjects in with relapsing or metastatic breast cancer whose risk level for febrile neutropenia is low and who are receiving second line or higher chemotherapy that incorporates doxorubicin/cyclophosphamide.

Detailed Summary: This study will assess treatment of febrile neutropenia in subjects with relapsing or metastatic breast cancer by enrolling a total of 12 subjects initially to receive 1 of 4 dose levels of EC-18 (3 subjects per dose level). Subjects will be evaluated for dose-limiting side effects that occur at a dose level. EC-18 administration will discontinued after a 3-week treatment period. EC-18 treatment will administered continuously for 21 days to coincide with the cycle of chemotherapy. The risk of infection based on absolute neutrophil count will be assessed during this period. After 21 days of EC-18 treatment, all subjects will be followed for a 4-week safety assessment.
Sponsor: Enzychem Lifesciences Corporation

Current Primary Outcome: Duration of Grade 4 neutropenia [ Time Frame: 15 days after starting chemotherapy ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Enzychem Lifesciences Corporation

Dates:
Date Received: February 24, 2017
Date Started: June 2017
Date Completion: March 2019
Last Updated: May 16, 2017
Last Verified: May 2017