"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 Limited8 个研究点分布在 1 个国家目标入组 100 人开始时间: 待定

试验速览

阶段: 4 期
发起方
入组人数: 100
试验地点: 8
主要终点: The primary efficacy endpoint will be

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

?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?

研究设计

分配方式: Permuted block randomization, fixed
盲法: Open Label

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 patients3.ANC > 1,500/uL4.Hemoglobin > 9 g/dL5.Platelets > 100,000/ul6.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 requirements10.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 procedures7.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.

结局指标

主要结局

The primary efficacy endpoint will be

时间窗: Duration of severe Neutropenia (defined as ANC < 0.5 × 109/L)

次要结局

Secondary efficacy endpoints(?Depth of ANC count(nadir) in each cycles as compared to baseline?Incidence of Febrile Neutropenia ? (Defined as a rise in axillary temperature to >38.5 °C for a duration of more than 1 hour while having an absolute neutrophil count < 0.5 × 109 /l)?Incidence of severe Neutropenia(defined as ANC < 0.5 × 109/L) ?Time to ANC recovery?Use of Antibiotics for the treatment of Febrile Neutropenia)

研究者

发起方

Intas Biopharmaceuticals Limited

研究点 (8)

Loading locations...

相似试验

已完成

不适用

A Open Label, Post Marketing Surveillance Study Following Transfusion of INTERCEPT Platelet ComponentsTransfusion Related Acute Lung Injury

NCT02549222Cerus Corporation2,291

尚未招募

4 期

A Study of Febuxostat Tablets for treatment of chronic Hyperuricemia

CTRI/2018/10/016116Ajanta Pharma Ltd383

招募中

Unknown

An observational study to evaluate the safety and tolerability of Amphotericin B Lipid suspension in patients with Invasive Fungal Infections.

CTRI/2017/08/009429Cipla Ltd250

已完成

4 期

Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest CongestionHealthy Subjects

NCT03725085Reckitt Benckiser LLC552

已完成

Unknown

A study to evaluate the safety and effect of Ropin HeavyÂ® injection for spinal anaesthesia in adult subjects

CTRI/2022/03/040917Neon Laboratories Ltd214