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Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

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ClinicalTrials.gov Identifier: NCT03104595
Recruitment Status : Recruiting
First Posted : April 7, 2017
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Enzychem Lifesciences Corporation

Brief Summary:

Part 1 of the study will determine the maximum tolerated dose (MTD) of EC-18 in subjects with relapsing or advanced breast cancer whose risk level for febrile neutropenia is low and who are receiving second line or higher chemotherapy that incorporates doxorubicin/cyclophosphamide.

Part 2 will evaluate the MTD in the same subject population.


Condition or disease Intervention/treatment Phase
Febrile Neutropenia Drug: EC-18 Phase 2

Detailed Description:

Part 1 of 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, and 2000 mg of EC-18. A total of 12 subjects are planned for enrollment. After 21 days of EC-18 treatment with starting administration of doxobubicin and cyclophosphamide (Day 1), all subjects will be followed for a 4-week safety assessment.

Part 2 is a randomized, placebo-controlled, double-blind, dose-expansion study. subjects will received the maximum tolerated dose identified in Part 1. Subjects will be treated for 3 weeks and followed for safety for 4 weeks. sixty five subjects are planned for Part 2


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: 3 + 3 dose escalation
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 13, 2017
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Arm Intervention/treatment
Experimental: Cohort 1
EC-18 500 mg
Drug: EC-18
oral administration
Other Name: EC-18 soft capsules

Experimental: Cohort 2
EC-18 1000 mg
Drug: EC-18
oral administration
Other Name: EC-18 soft capsules

Experimental: Cohort 3
EC-18 1500 mg
Drug: EC-18
oral administration
Other Name: EC-18 soft capsules

Experimental: Cohort 4
EC-18 2000 mg
Drug: EC-18
oral administration
Other Name: EC-18 soft capsules




Primary Outcome Measures :
  1. Duration of Grade 4 neutropenia [ Time Frame: 15 days after starting chemotherapy ]
    Complete blood count and absolute neutrophil count assessed daily to determine febrile neutropenia


Other Outcome Measures:
  1. Incidence of adverse events [ Time Frame: 3-week treatment period and follow-up visit at day 36 ]
    Incidence of treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, adverse events by severity grade

  2. Clinical laboratory evaluations [ Time Frame: 3-week treatment period and follow-up visit at day 36 ]
    Clinical laboratory tests (hematology, clinical chemistry, coagulation, and urine test result analysis) -- absolute values and changes from the baseline

  3. Vital signs [ Time Frame: 3-week treatment period and follow-up visit at day 36 ]
    Absolute values and changes from baseline in vital signs

  4. 12-lead electrocardiogram (ECG) [ Time Frame: 3-week treatment period and follow-up visit at day 36 ]
    Absolute values and changes from baseline ECG



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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women ≥19 years of age
  2. Subjects who have voluntarily signed the informed consent prior to the screening tests to participate in the study
  3. Subjects who have been diagnosed as adenocarcinoma of the breast and relapsed after adjuvant or primary (neoadjuvant) chemotherapy, and thus through history have been confirmed to be candidates for chemotherapy of second line or higher (including hormonal therapy) combined with doxorubicin and cyclophosphamide to treat relapsed or metastatic disease.
  4. Subjects with adequate organ function based on the following clinical laboratory values in the final examination performed within 14 days prior to dosing:

    • Neutrophil count (ANC): ≥1,500/mm3
    • Platelet count: ≥10.0×104/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
  5. Subjects whose Eastern Cooperative Oncology Group (ECOG) performance score is 0-1.
  6. For women of child bearing potential, subjects should have willingness to use acceptable contraceptive methods during the entire clinical study period.
  7. Subjects who are capable of understanding the overall procedure of the clinical trial and are willing to participate in compliance with all test procedures.

Exclusion Criteria:

  1. Subjects with active and inactive hepatitis, patients with HIV, or other uncontrolled infectious disease.
  2. Subjects who are currently undergoing/receiving antiretroviral therapy due to previous or current immunosuppressive virus infection, hepatitis B surface antigen positive, or positive hepatitis C disease.
  3. Subjects who received radiation therapy within 4 weeks of dosing.
  4. 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.
  5. Subjects with a history of intolerance for granulocyte colony stimulating factor treatment
  6. Subjects who are expected to show hypersensitivity to the study drug or its ingredients
  7. Subjects with a positive urine pregnancy test result prior to the screening visit or the first administration of the study drug
  8. Subjects who took any other study drug used in a clinical trial within 30 days prior to the screening visit.
  9. 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 is likely to interfere with satisfactory study completion or confound its outcome.
  10. Subjects with unstable heart disease (Example: Congestive heart failure, arrhythmia, symptomatic coronary artery disease); Myocardial infarction within 6 months before initiation of the study.
  11. Subjects with left ventricular ejection fraction (LVEF) < 50% at screening.
  12. Significant neurological or psychiatric disorders including dementia or seizures.
  13. Subjects with poorly controlled hypertriglyceridemia (>500mg/dL) with use of hypolipidemic agents.
  14. Subjects with poorly controlled diabetes (fasting glucose> 150 mg / dL or HbA1c ≥ 8%).
  15. Subjects who have received systemic chemotherapy with doxorubicin anticancer agent to treat metastatic or recurrent breast cancer
  16. Subjects with Grade 2 or higher peripheral sensory neuropathy prior to the screening visit or first dosing of the study drug
  17. Subjects who have undergone significant gastrectomy with intractable nausea and vomiting, chronic gastrointestinal disease, or clinically significant sequelae, which would interfere with proper absorption of the study drug
  18. Subjects who were administered with systemic antibiotics within 14 days prior to administration of the study drug
  19. Subjects whose cumulative dose of doxorubicin exceeds 240 mg/m2'
  20. Subjects who are currently receiving trastuzumab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03104595


Contacts
Contact: Soyoun Ahn, Ph.D. 82-2-6212-7120 sahn@enzychem.com

Locations
Korea, Republic of
Yonsei University Health System Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Contact: Joo-Hyuk Sohn, M.D., Ph.D.    82-2-2228-8135    oncosohn@yuhs.ac   
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Contact: Sung-Bae Kim, M.D., Ph.D    82-2-3010-3217    sbkim3@amc.seoul.kr   
Sponsors and Collaborators
Enzychem Lifesciences Corporation
Investigators
Study Director: Soyoun Ahn, Ph.D. Enzychem Lifesciences

Responsible Party: Enzychem Lifesciences Corporation
ClinicalTrials.gov Identifier: NCT03104595     History of Changes
Other Study ID Numbers: EC-18-201
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Enzychem Lifesciences Corporation:
EC-18, febrile neutropenia, breast cancer, chemotherapy

Additional relevant MeSH terms:
Neutropenia
Fever
Febrile Neutropenia
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Signs and Symptoms