CTRI/2009/091/000694未知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, 91-40-2304141814 个研究点 分布在 1 个国家目标入组 150 人开始时间: 待定
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 14
- 主要终点
- Duration of severe (grade 4) neutropenia in cycle 1.
研究概览
简要总结
This study is 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 150 cancer patients receiving cytotoxic chemotherapy. Study duration includes 2 weeks of screening, 18 weeks of treatment with a follow-up period of 6 months and study will be conducted in 14 centers in India. Primary Objective is to establish non-inferiority of Peg G-CSF with Grafeel® for duration of severe (grade 4) neutropenia in cycle 1 of chemotherapy.
研究设计
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
入选标准
- •Signed and dated written informed consent2)Patients aged 18 to 70 years3)Chemo naive patients4)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 neutropenia5)Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 16)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/L7)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/min9)If female:Women without childbearing potential (eg.
- •Post menopausal, surgery/ radiation therapy terminating reproductive potential etc)ORWomen 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
- •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 disease2)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 screening3)Patients with Congestive Heart Failure class III/IV as per New York Heart Association classification4)LVEF <50%, except patients receiving doxorubicin containing chemotherapy, wherein LVEF <55%5)Clinically symptomatic brain metastases6)A positive serologic test for the Human Immunodeficiency Virus (HIV) or unresolved Hepatitis B or C virus infection7)Pregnant or breast-feeding women8)Patients who have received any other investigative drugs within 30 days before randomization9)History of allergic reactions to the study drug or its constituents10)Previous exposure to any colony stimulating factor11)Patients previously diagnosed with sickle cell disorder12)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.
结局指标
主要结局
Duration of severe (grade 4) neutropenia in cycle 1.
时间窗: 3 weeks
次要结局
- Incidence of severe neutropenia by cycle and across all cycles.(18 weeks)
- Incidence of febrile neutropenia (FN) by cycle and across all cycles.(18 weeks)
- ANC nadir, defined as patients lowest ANC for cycle 1.(3 weeks)
- Time to ANC recovery, defined as the time in days from chemotherapy administration until patients ANC increased to ≥ 2.0 X 109/l after the expected nadir for cycle 1.(3 weeks)
研究者
研究点 (14)
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