A randomized and open-label dose-finding, phase 2, efficacy, safety and pharmacokinetic study of once-per-cycle prophylactic injections of ANF-RHO TM versus pegfilgrastim (NeulastaR) in non-metastatic breast cancer patients at high risk of chemotherapy-induced neutropenia (CIN) - PGFN-001

Prolong Pharmaceuticals0 个研究点目标入组 24 人开始时间: 待定最近更新: 2024年2月28日

试验速览

暂无简介。

•1. Adult female patients, 18 years of age or older;2. Signed and dated written consent/assent by the patient or legally authorized representative;3. Histologically confirmed non-metastatic breast cancer;4. ECOG performance status * 2;5. Myelosuppressive chemotherapy naive;6. Scheduled to receive and anticipated to complete the following chemotherapy regimen:;a) FEC (fluorouracil/epirubicin (100)/cyclophosphamide)(3 cycles); ;b) Docetaxel (3 cycles) chemotherapy;7. White blood cell (WBC) * 3 × 109/L; Absolute neutrophil count (ANC) * 2.0 × 109/L; platelet count * 100 × 109/L; and hemoglobin * 10 g/dL (6.2 mmol/L);8. Adequate cardiac function (e.g., LVEF > 50% as determined by standard care) and adequate hepatic function (e.g., liver transaminases <; 2.5 x ULN);9. Women of childbearing potential with a negative serum pregnancy test and using a highly effective method of birth control (i.e., one that results in a less than 1% per year ;failure rate when used consistently and correctly, such as implants, injectables, combined oral contraceptives and intrauterine devices (IUDs)). Periodic abstinence is not an ;acceptable contraceptive method during the study period.

•1. Known hypersensitivity to E.coli derived products or polyethylene glycol;2. No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated *5 years ago with curative intent;3. Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease;4. Clinical diagnosis or history of chronic infection such as hepatitis B virus(HBV), hepatitis C Virus (HCV) or Human immunodeficiency virus(HIV) or history of tuberculosis;5. Previous exposure to filgrastim, pegfilgrastim or lipegfilgrastim within 30 days before randomization;6. Treatment with systemically active antibiotics within 72 hours before chemotherapy;7. Chronic use of oral corticosteroids;8. Participation in a clinical pharmacological trial within 30 days before randomization;9. Clinical diagnosis of drug abuse or substance abuse within 30 days prior to screening;10. Documented alcohol abuse within 30 days prior to screening.;11. Unwilling and/or not capable of ensuring compliance with the provisions of the study protocol;12. Pregnant or breastfeeding women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum HCG laboratory test;13. Other serious medical condition that would prevent individual from receiving protocol treatment

发起方

Prolong Pharmaceuticals