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临床试验/CTRI/2009/091/000694
CTRI/2009/091/000694招募中3 期

A randomized, multi-center, open label study to evaluate the efficacy and safety of Peg G-CSF as compared to Grafeel® in the prophylaxis of severe neutropenia in cancer patients receiving cytotoxic chemotherapy.

DR.REDDY'S LABORATORIES LTD.Biologics Development Centre , Survey No.47, Bachupalli, Qutubullapur, Hyderabad-500090, A.P, IndiaFax: +91-40-44644507, 91-40-230414180 个研究点目标入组 150 人开始时间: 待定最近更新:
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试验速览

阶段
3 期
状态
招募中
发起方
入组人数
150
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)Signed and dated written informed consent
  • •2)Patients aged 18 to 70 years
  • •3)Chemo naive patients
  • •4)Patients diagnosed with unresectable stage IIIB or IV NSCLC or metastatic breast cancer requiring first line cytotoxic chemotherapy regimen associated with intermediate risk of febrile neutropenia and significant risk of severe neutropenia
  • •5)Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 1
  • •6)Absolute Neutrophil Count (ANC) greater than or equal to 1.5 x 10^9/L and Platelets greater than or equal to 100 x 10^9/L
  • •7)Adequate liver function: bilirubin less than or equal to 1.5mg/dL, ALT/AST/ alkaline phosphatase less than 2 times the upper normal value (unless due to liver involvement in which case ALT/AST less than 4 times the upper normal value, and alkaline phosphatase without limit)
  • •8)Adequate renal function: serum creatinine less than or equal to 1.5 mg/dL and GFR greater than or equal to 50 ml/min
  • •9)If female:
  • •Women without childbearing potential (eg. Post menopausal, surgery/ radiation therapy terminating reproductive potential etc)
  • •Women with childbearing potential using an approved contraceptive method (intrauterine device, birth control pills, or barrier device) during and for 3 months after completion of study, and having negative urine Beta-HCG test prior to study enrolment

排除标准

  • •1)Any clinically significant findings on history or examination that, in the opinion of the investigator, would preclude administration of chemotherapy and Grafeel®/ Peg G-CSF therapy in the full doses and clinically significant cardiac disease, neuropathy or other disease
  • •2)Any active cancer or history of prior malignancy except carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin or any surgically cured malignancies diagnosed 5 years or more before screening
  • •3)Patients with Congestive Heart Failure class III/IV as per New York Heart Association classification
  • •4)LVEF <50%, except patients receiving doxorubicin containing chemotherapy, wherein LVEF <55%
  • •5)Clinically symptomatic brain metastases
  • •6)A positive serologic test for the Human Immunodeficiency Virus (HIV) or unresolved Hepatitis B or C virus infection
  • •7)Pregnant or breast-feeding women
  • •8)Patients who have received any other investigative drugs within 30 days before randomization
  • •9)History of allergic reactions to the study drug or its constituents
  • •10)Previous exposure to any colony stimulating factor
  • •11)Patients previously diagnosed with sickle cell disorder
  • •12)Chronic use of oral corticosteroids (except low dose with no more than 20 mg/d prednisolone or equivalent for COPD)
  • •13)Any illness or condition that in the opinion of the investigator could affect the safety of the patient
  • •14)Radiation therapy within 4 weeks of randomization into this study

研究者

发起方
DR.REDDY&#039;S LABORATORIES LTD.Biologics Development Centre , Survey No.47, Bachupalli, Qutubullapur, Hyderabad-500090, A.P, IndiaFax: +91-40-44644507, 91-40-23041418

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