"A Prospective, Comparative, Randomized, Multicenteric, Open label Post Marketing Surveillance study to compare the Safety and efficacy of once-per-cycle Peg Filgrastim (6 mg/0.6 ml) of Intas Biopharmaceuticals Ltd. to NEULASTIM of ROCHE in support of AT chemotherapy in females patients with Advanced (Stage III and IV) breast cancer"

Intas Biopharmaceuticals Limited0 个研究点目标入组 100 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 4 期
状态: 尚未招募
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1.Female Patients aged 18 years and above suffering from advanced (Stage III and IV) Breast Cancer eligible for receiving AT (Docetaxel- 75 mg/m2, Doxorubicin- 50 mg/m2) chemotherapy.
•2.GCSF and Peg- GCSF naive patients
•3.ANC > 1,500/uL
•4.Hemoglobin > 9 g/dL
•5.Platelets > 100,000/ul
•6.Patients with serum creatinine ≤ 1.5 mg/dL
•7.AST/ALT < 1.5 x ULN, alkaline phosphatase ≤ 2.5 x ULN, Bilirubin ≤ 2 x ULN
•8.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study
•9.Patients able to adhere to the study visit schedule and other protocol requirements
•10.Completion of previous chemotherapy more than 4 weeks before randomization

排除标准

•1.History of prior malignancy with myeloid characteristics (e.g., myelodysplastic syndromes, acute or chronic myelogenous leukemia?s) or Any premalignant myeloid condition other than breast cancer with the exception of curatively treated basal cell or squamous cell carcinoma of the skin, in situ cervical carcinoma, or other surgically cured malignancy ?
•2.Documented active infection at the time of enrolment requiring use of systemic anti- infective or use of any anti infective ≤ 72 hours before the study drug administration.
•3.Documented positive test for human immunodeficiency virus (HIV) infection ? known hypersensitivity to E coli derived products [e.g., Filgrastim pegfilgrastim HUMULIN® Insulin, L-1Asparaginase, HUMATROPE® Growth Hormone, INTRON A®]
•4.Subject is currently enrolled in or 4 weeks have not passed since completing other device or drug trial(s) or is receiving other investigational agent(s) other than placebo (confirmation of prior treatment must be documented)
•5.Pregnant or breast-feeding (for subjects of child bearing potential) patients or patients not using adequate contraception (for subjects of child bearing potential)
•6.Previous participation in this study - Inability or unwillingness to comply with the protocol procedures
•7.Had undergone prior radiation therapy within 4 weeks of randomization into this study (with the exception of spot radiation for bone metastases),
•8.Prior bone marrow or stem-cell transplantation, or Prior total cumulative lifetime exposure to doxorubicin more than 240 mg/m2 or epirubicin more than 600 mg/m2.
•9.Clinically symptomatic brain metastasis

研究者

发起方

Intas Biopharmaceuticals Limited

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