IRCT2013042212398N4已完成3 期
A Randomized parallel group clinical trial to determine the effectiveness, safety and tolerability of Actoverco Filgrastim and Actoverco Pegfilgrastim compared to Neupogen® for prevention of chemotherapy induced neutropenia in the treatment of the breast cancer
Actoverco Pharmaceutic Company0 个研究点目标入组 156 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 156
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
- 年龄范围
- 18 years 至 70 years（—）
- 性别
- Female
入选标准
- •Inclusion Criteria: Female patients aged 18 to 70 years old; Signed informed consent obtained prior to initiation the study; Patients diagnosed having high risk stage 2 or stage 3 and or 4 of breast cancer (by histopathological or cytological diagnosis) and need chemotherapy; A priori has been decided to be treated with G-CSF and subjects eligible for G-CSF therapy according to indications and clinical use in the product monograph; Any acute adverse effects of prior therapy must have resolved to = NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1; ECOG Performance Status 0 or 1 as determined on Day 1 of Cycle 1 prior to administration of chemotherapy; Patients must have adequate organ function including the following: a. Adequate bone marrow functions, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: Hb=10 g/dL (transfusion permitted to be included in the trial WBC=3,5 x 109/L,Absolute neutrophil count (ANC) =1.5 x 109/L Platelets =100 x 109/L , b. Adequate renal and hepatic function, as determined within 1 day prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by: i. Hepatic: Bilirubin = 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria: ii. a) Alkaline phosphatase within normal reference range and both AST and ALT >2.5 x ULN; or b) Alkaline phosphatase <2.5 x ULN and both AST and ALT <1.5 x ULN; or c ) Alkaline phosphatase <5 x ULN and both AST and ALT within normal reference range; Renal: Serum creatinine = 1.5 mg/dL or = 90 ml/min GFR; Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy (Day 1 of Cycle 1) and use at least one form of contraception as approved by the Investigator for four weeks prior to the study and during the study. For the purposes of this study, child-bearing potential is defined as: All female patients unless they are post-menopausal for at least one year or are surgically sterile”. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge or contraceptive suppository); Life expectancy more than 3 months; Entering to the study before the second cycle of chemotherapy; Ability to co-operate with the treatment and follow up.
排除标准
- •Safety of treatment dependent criteria: Presence of any serious concomitant systemic disorders incompatible with the administration of G-CSF or any systemic disease that can influence the patient's safety (according to doctor’s diagnosis); history of hypersensitivity to natural or recombinant G-CSF, or hypersensitivity to human albumin or any other component of the formulation; History of poorly controlled hypertension (BP > 180/110 mmHg) and/or other clinically significant major disease (according to doctor’s diagnosis); Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days; Pregnant or breast-feeding patients; Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV; Known bleeding disorder Criteria dependent on compliance with study procedures, or the evaluation of the response: Unwilling to use a reliable and acceptable contracept
研究者
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