Overview

Study of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy

Status:
Completed
Trial end date:
2014-02-01
Target enrollment:
0
Participant gender:
Female
Summary
A Phase I, dose escalation study to evaluation the safety and pharmacokinetics/pharmacodynamics of F-627 in female breast cancer patients who received up to 4 cycles of Epirubicin and Cyclophosphamide. 18 patients (6 patients each cohort) were assigned to three escalated dose cohorts of 80, 240 and 320 µg/kg.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Generon (Shanghai) Corporation Ltd.
Collaborator:
Fudan University
Treatments:
Cyclophosphamide
Epirubicin
Lenograstim
Criteria
Inclusion Criteria:

1. 18-75 years old.

2. Female breast cancer patients after resection who planned to receive 4 cycles of
adjuvant chemotherapy contains epirubicin and cyclophosphamide.

3. East Cooperative Oncology Group (ECOG) performance 0-1.

4. Absolute neutrophil count (ANC) ≥ 2.0 × 109/L, hemoglobin (Hb) ≥ 11.0 g/dl, and
platelets (PLT) ≥ 100 × 109/L prior to chemotherapy.

5. Liver and kidney function tests were within normal reference range.

6. Left ventricular ejection fraction (LVEF) > 50%.

7. Willing to provide written informed consent and to compliant study procedure.

Exclusion Criteria:

1. Pregnancy or lactating women; female with pregnancy potential had positive pregnancy
test prior to study treatment.

2. Expected survival < 12 months.

3. Patients received radiotherapy within 4 weeks prior to enrollment.

4. Patients received neoadjuvant chemotherapy prior to resection of breast cancer.

5. Patients received bone marrow or hemopoietic stem cell transplantation;

6. Patient was with metastatic cancer other than breast cancer.

7. Patients received Granulocyte Colony-stimulating Factor (G-CSF) treatment within 6
weeks prior to enrollment.

8. Acute congestive heart failure, myocardial disease, or myocardial infarction diagnosed
by clinical, electrocardiography, or any other medical procedure.

9. Any disease that possibly cause splenomegaly.

10. Acute infections, chronic active hepatitis B infection within 1 year (except subject
with negative hepatitis B antigen prior to enrollment) or history of hepatitis C
infection.

11. Patients with active tuberculosis (TB), or had ever the history of close contact with
patients with TB except negative result in tuberculin test; or under TB treatment; or
suspected TB by chest X-ray.

12. Known the positive result of human immunodeficiency virus (HIV) or patients with
acquired immune deficiency syndrome (AIDS).

13. Patients with sickle-cell anemia.

14. Patients with alcohol abuse or drug addiction that may affect the compliance of the
study.

15. Patients with allergy to proteins extracted from Escherichia coli, G-CSF, or drug
excipient.

16. Patients took other investigational products within 4 weeks prior enrollment.

17. Patients with diseases or symptoms that may not be suitable to be enrolled in this
study based on investigator's judgment.