Full results & analysis
Available in the Gosset platform where reported.
Trial intelligence / Profile preview
EC-18 for Chemotherapy-Induced Neutropenia in Advanced Breast Cancer
NCT03104595Phase 2
Key facts
- Status
- Completed
- Start
- Oct 2017
- Primary completion
- Nov 2019
- Countries
- 1
- Sponsor
- Enzychem Lifesciences
- Modality
- Small Molecules
- Drugs
- mosedipimod
- Conditions
- chemotherapy-induced neutropenia (CIN)febrile neutropenia (FN)
01
Overview
Phase 2, open-label trial of mosedipimod in chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) (6 cohorts), sponsored by Enzychem Lifesciences. Primary endpoint: Duration of Grade 4 Neutropenia at 21 days. Started Oct 2017; status: completed.
02
Design
6 arms- Study design
- Non-randomizedOpen-label
Cohort 1
EC-18 500 mg
Cohort 2
EC-18 1000 mg
Cohort 3
EC-18 1500 mg
Cohort 4
EC-18 2000 mg
Cohort 5
EC-18 3000 mg
Cohort 6
EC-18 4000 mg
03
Who it enrols
Women >=19 years with relapsed adenocarcinoma of the breast, candidates for second-line or higher combination chemotherapy with doxorubicin and cyclophosphamide, with adequate organ function and ECOG 0-1.
04
Endpoints
Primary
Duration of Grade 4 Neutropenia
Secondary
Number of Participants With Grade 3-4 Neutropenia
Number of Participants With Febrile Neutropenia
Beyond the preview
Go deeper on NCT03104595.
Full results, competitive context and analysis are in the Gosset platform.
Competitive context
Available in the Gosset platform where reported.
Bring the full picture into focus.
See how Gosset can support your research on NCT03104595.