Febrile NeutropeniaPhase 1/2NCT03104595
Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer
A Phase 1/2 study testing EC-18 in people with Febrile Neutropenia, run by Enzychem Lifesciences Corporation at 3 sites in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- EC-18
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 30 Oct 2017to 5 Dec 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ≥19 years of age
- Subjects who have voluntarily signed the informed consent prior to the screening tests to participate in the study
- Subjects who have been diagnosed as adenocarcinoma of the breast and relapsed after adjuvant or primary (neoadjuvant) chemotherapy, and was confirmed based on documented medical history to be candidates for second-line or higher combination chemotherapy with doxorubicin and cyclophosphamide to treat relapsed or metastatic disease.
- Subjects with adequate function of major organs based on the following clinical laboratory values in the latest test performed within 28 days prior to IP dosing:
- Neutrophil count (ANC): ≥1,500/mm3
- Platelet count: ≥10.0×10^4/mm3
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- Hemoglobin: ≥9.0 g/dL
- AST, ALT: ≤3.0 x ULN
- Serum total bilirubin: ≤1.5 mg/dL
- Serum creatinine: ≤1.5 mg/dL
- Subjects whose Eastern Cooperative Oncology Group (ECOG) performance score is 0-1.
- For women of child bearing potential, subjects should have willingness to use acceptable contraceptive methods during the entire clinical study period.
- Subjects who are capable of understanding the overall procedure of the clinical study and are willing to participate in compliance with all test procedures.
Who cannot join
- Subjects with active and inactive hepatitis, patients with history of HIV, or other uncontrolled infectious disease.
- Subjects with a history of HIV positive or currently undergoing/received antiretroviral therapy, and subjects with a history of hepatitis B surface antigen positive, or current positive hepatitis C disease.
- Subjects who received radiation therapy within 4 weeks prior to assignment to treatment group.
- Subjects who have been diagnosed within 5 years with other types of cancer except for those who have been appropriately treated for superficial non-melanoma skin cancer or cervical intraepithelial neoplasia.
- Subjects with a history of intolerance for granulocyte colony stimulating factor treatment
- Subjects who are expected to show hypersensitivity to the IP or its ingredients
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- Subjects with a positive urine pregnancy test result at screening visit or before the first administration of the study drug
- Subjects who took any other investigational product in other clinical study within 30 days prior to screening visit.
- Clinically significant unstable medical abnormality; psychiatric disorder, chronic disease, alcohol or drug use disorder, or other significant biological, psychological, or social factor, which in the investigator's opinion, unfavorably affects the risk-benefit ratio of study participation or likely to affect study results.
- Subjects with heart disease (i.e. congestive heart failure, arrhythmia, symptomatic coronary artery disease); Myocardial infarction within 6 months before initiation of the study.
- Subjects with left ventricular ejection fraction (LVEF) < 50% at screening.
- Significant neurological or psychiatric disorders including dementia or seizures.
- Patients with dyslipidemia not controlled by drugs [based on LDL-C and TG levels for which treatment is recommended by the Korean dyslipidemia treatment guidelines and the U.S. National Cholesterol Education Program-Adult Treatment Panel III]
- Uncontrolled diabetes mellitus (HbA1c >7%; if the level is confirmed after 6 months or longer treatment with oral hypoglycemic agents or insulin)
- Subjects who have received systemic chemotherapy with doxorubicin to treat metastatic or recurrent breast cancer
- Subjects with grade 2 or higher peripheral sensory neuropathy at screening visit or before the first dosing of the study drug
- Subjects who have undergone significant gastrectomy along with intractable nausea and vomiting, chronic gastrointestinal disease, or clinically significant sequelae, which would interfere with proper absorption of the study drug
- Subjects who administered systemic antibiotics within 14 days prior to administration of the study drug
- Subjects whose cumulative dose of doxorubicin exceeded 240 mg/m2
- Subjects who were currently receiving trastuzumab
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
National Cancer Center
Gyeonggi-do, Gyeonggi-do, 10408
Yonsei University Health System Severance Hospital
Seoul, Seoul, 03722
Asan Medical Center
Seoul, Seoul, 05505
About this study
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
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.
Read the 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
- Febrile Neutropenia
- Being tested
- EC-18
- Keywords
- EC-18, febrile neutropenia, breast cancer, chemotherapy
- Medical subject headings
- Febrile Neutropenia, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EC-18Drug
Also called EC-18 soft capsules
oral administration
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | EC-18 500 mg Receives: Drug: EC-18 |
| Cohort 2 | Experimental | EC-18 1000 mg Receives: Drug: EC-18 |
| Cohort 3 | Experimental | EC-18 1500 mg Receives: Drug: EC-18 |
| Cohort 4 | Experimental | EC-18 2000 mg Receives: Drug: EC-18 |
| Cohort 5 | Experimental | EC-18 3000 mg Receives: Drug: EC-18 |
| Cohort 6 | Experimental | EC-18 4000 mg Receives: Drug: EC-18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Grade 4 Neutropenia
Duration of Grade 4 neutropenia during Cycle 1 of chemotherapy, based on absolute neutrophil count (ANC) assessed using NCI CTCAE v4.03.
Measured: During Cycle 1 of chemotherapy (up to 21 days)
Secondary outcomes (2)
Number of Participants With Grade 3-4 Neutropenia
Neutropenia was graded according to NCI CTCAE v4.03. This outcome reports the number of participants who experienced Grade 3 or Grade 4 neutropenia during Cycle 1 of chemotherapy.
Measured: During Cycle 1 of chemotherapy
Number of Participants With Febrile Neutropenia
Febrile neutropenia was assessed based on absolute neutrophil count (ANC) and body temperature according to NCI CTCAE v4.03. This outcome reports the number of participants who experienced febrile neutropenia during the study period.
Measured: For 15 days after starting chemotherapy (except for Days 3 and 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start30 Oct 2017
- Primary completion26 Nov 2019
- Study completion5 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Febrile NeutropeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 3 + 3 dose escalation
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enzychem Lifesciences Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sung-Bae Kim, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104595
- Sponsor's protocol ID
- EC-18-201
- Status last verified
- Aug 2023
- First submitted
- 24 Feb 2017
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03104595
- Acronym / sponsor ID
- EC-18-201
- Conditions
- Febrile Neutropenia
- Keywords
- EC-18, febrile neutropenia, breast cancer, chemotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Enzychem Lifesciences CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 5 Dec 2019 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- 3 + 3 dose escalation
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: EC-18EC-18 500 mg |
| Cohort 2 | Experimental | Drug: EC-18EC-18 1000 mg |
| Cohort 3 | Experimental | Drug: EC-18EC-18 1500 mg |
| Cohort 4 | Experimental | Drug: EC-18EC-18 2000 mg |
| Cohort 5 | Experimental | Drug: EC-18EC-18 3000 mg |
| Cohort 6 | Experimental | Drug: EC-18EC-18 4000 mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Women ≥19 years of age
- Subjects who have voluntarily signed the informed consent prior to the screening tests to participate in the study
- Subjects who have been diagnosed as adenocarcinoma of the breast and relapsed after adjuvant or primary (neoadjuvant) chemotherapy, and was confirmed based on documented medical history to be candidates for second-line or higher combination chemotherapy with doxorubicin and cyclophosphamide to treat relapsed or metastatic disease.
- Subjects with adequate function of major organs based on the following clinical laboratory values in the latest test performed within 28 days prior to IP dosing:
- Subjects whose Eastern Cooperative Oncology Group (ECOG) performance score is 0-1.
Key exclusion criteria (20 listed)
- Subjects with active and inactive hepatitis, patients with history of HIV, or other uncontrolled infectious disease.
- Subjects with a history of HIV positive or currently undergoing/received antiretroviral therapy, and subjects with a history of hepatitis B surface antigen positive, or current positive hepatitis C disease.
- Subjects who received radiation therapy within 4 weeks prior to assignment to treatment group.
- Subjects who have been diagnosed within 5 years with other types of cancer except for those who have been appropriately treated for superficial non-melanoma skin cancer or cervical intraepithelial neoplasia.
- Subjects with a history of intolerance for granulocyte colony stimulating factor treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EC-18Also: EC-18 soft capsulesoral administration | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6 |
Primary outcome
Duration of Grade 4 Neutropenia
Time frame: During Cycle 1 of chemotherapy (up to 21 days)
Duration of Grade 4 neutropenia during Cycle 1 of chemotherapy, based on absolute neutrophil count (ANC) assessed using NCI CTCAE v4.03.
2 secondary outcomes
Number of Participants With Grade 3-4 Neutropenia
Time frame: During Cycle 1 of chemotherapy
Number of Participants With Febrile Neutropenia
Time frame: For 15 days after starting chemotherapy (except for Days 3 and 4).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung-Bae Kim, MD, PhD principal investigator
Asan Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing EC-18 in people with Febrile Neutropenia, run by Enzychem Lifesciences Corporation at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Grade 4 Neutropenia (time frame: During Cycle 1 of chemotherapy (up to 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.