Management of Severe Chemotherapy-induced Neutropenia in Advanced Breast Cancer

• Status: Unknown status
• Trial end date: 2019-03-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Enzychem Lifesciences Corporation

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