Trials / Completed
CompletedNCT03104595
Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 28 (actual)
- Sponsor
- Enzychem Lifesciences Corporation · Industry
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | EC-18 | oral administration |
Timeline
- Start date
- 2017-10-30
- Primary completion
- 2019-11-26
- Completion
- 2019-12-05
- First posted
- 2017-04-07
- Last updated
- 2023-08-15
Locations
3 sites across 1 country: South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03104595. Inclusion in this directory is not an endorsement.