Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

NCT03104595 | Completed Phase 1 FDA Drug

• 1 other identifier: EC-18-201
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Febrile Neutropenia

Keywords

EC-18, febrile neutropenia, breast cancer, chemotherapy

Outcome Measures

Primary Outcomes (1)

• Duration of Grade 4 neutropenia

  Complete blood count and absolute neutrophil count assessed daily to determine febrile neutropenia

  15 days after starting chemotherapy

Secondary Outcomes (2)

• Incidence of Grade 3-4 neutropenia

  For 15 days after starting chemotherapy (except Day 3 and 4)

• Incidence of febrile neutropenia

  For 15 days after starting chemotherapy (except Day 3 and 4)

Other Outcomes (4)

• Incidence of adverse events

  3-week treatment period and follow-up visit at day 36

• Clinical laboratory evaluations

  3-week treatment period and follow-up visit at day 36

• Vital signs

  3-week treatment period and follow-up visit at day 36

Study Arms (6)

Cohort 1

EXPERIMENTAL

EC-18 500 mg

Drug: EC-18

Cohort 2

EXPERIMENTAL

EC-18 1000 mg

Drug: EC-18

Cohort 3

EXPERIMENTAL

EC-18 1500 mg

Drug: EC-18

Cohort 4

EXPERIMENTAL

EC-18 2000 mg

Drug: EC-18

Cohort 5

EXPERIMENTAL

EC-18 3000 mg

Drug: EC-18

Cohort 6

EXPERIMENTAL

EC-18 4000 mg

Drug: EC-18

Interventions

EC-18 DRUG

oral administration

Also known as: EC-18 soft capsules

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

• Age: 19 Years+
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Enzychem Lifesciences Corporation: lead

Study Sites (3)

National Cancer Center

Gyeonggi-do, 10408, South Korea

Location

Yonsei University Health System Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

MeSH Terms

Conditions

Febrile Neutropenia; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sung-Bae Kim, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 3 + 3 dose escalation

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: April 7, 2017
• Study Start: October 30, 2017
• Primary Completion: November 26, 2019
• Study Completion: December 5, 2019
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)