A Single-Center, Open-Label, Dose-Escalation Phase I Clinical Trial of Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein for Injection as an Adjuvant to Chemotherapy in Subjects With Breast Cancer

2012-F-627-CH1

A Phase I, dose escalation study to evaluate 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.

2012-12-01

2013-12-01

2013-12-01

Completed

Early phase I

18

Inclusion Criteria: 1. 18-75 years old. 2. Female postoperative breast cancer patients who require adjuvant chemotherapy, and are planned to receive 4 cycles of EC chemotherapy; 3. East Cooperative Oncology Group (ECOG) performance 0-1. 4. Absolute neutrophil count (ANC) ≥ 2.0 × 10\^9/L, hemoglobin (Hb) ≥ 11.0 g/dl, and platelets (PLT) ≥ 100 × 10\^9/L prior to chemotherapy. 5. Hepatic and renal function within the normal range;. 6. Left ventricular ejection fraction (LVEF) \> 50%. 7. Willing to sign the informed consent form and able to comply with protocol requirements Exclusion Criteria: 1. Women in pregnancy or breastfeeding; Women of child-bearing potential have a positive pregnancy test result prior to the first dose; 2. Life expectancy less than 12 months; 3. Radiation therapy within 4 weeks prior to enrollment; 4. Breast cancer patients who have received neoadjuvant chemotherapy before radical mastectomy; 5. Prior bone marrow or stem cell transplant; 6. With other malignant tumors other than breast cancer; 7. Have received granulocyte colony stimulating factor (G-CSF) treatment within 6 weeks prior to enrollment; 8. Diagnosed with acute congestive heart failure, cardiomyopathy, or myocardial infarction by clinical diagnosis, electrocardiograph (ECG) or other approaches; 9. With any disease that may cause splenomegaly; 10. With acute infection, chronic active Hepatitis B within 1 year (unless patients tested negative for HBsAg prior to enrollment), or Hepatitis C; 11. History of tuberculosis (TB); history of TB exposure, unless negative for tuberculin test; TB patients undergoing treatment; or suspected TB evaluated by chest x-ray; 12. Known human immunodeficiency virus (HIV) positive or acquired immune deficiency syndrome (AIDS); 13. With sickle cell anemia; 14. With alcohol or drug abuse that may affect the compliance with the study; 15. With known hypersensitivity to E. coli derived proteins, G-CSF, or excipients; 16. Has received any other investigational drug within 4 weeks prior to enrollment; 17. Patients with diseases or symptoms unsuitable for participating in the clinical trial based on the investigator's judgment;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ACTUAL'}}

2024-02-23