IRCT2013062613776N1已完成3 期
Phase III Trial Comparing Filgrastim (AryaTinaGene) to Neupogen (Amgen) in the Prevention of Neutropenic Complications in Breast Cancer Patients in Pange-Azar hospital of Gorgan
AryaTinaGene Biopharm Co.0 个研究点目标入组 100 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
- 100
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 90 years（—）
- 性别
- Female
入选标准
- •The study population consisted of women = 18 years of age
- •with metastatic or localized histopathologically proven
- •breast cancer. Patients with localized cancer were required
- •to have = stage II disease with = 1 positive regional node.
- •Additional inclusion criteria included: Karnofsky performance
- •status = 70% for patients = 70 years of age and = 90%
- •for patients > 70 years of age; adequate hematologic function
- •(absolute neutrophil count [ANC] =3000 cells/µL,
- •platelet count >100,000/µL, hemoglobin [Hb] = 8 g/dL); adequate
- •hepatic function (bilirubin = 1.5 × upper limit of normal
- •[ULN], aspartate aminotransferase and alanine aminotransferase
- •= 2.5 × ULN, alkaline phosphatase = 5 × ULN);
- •creatinine = 2.0 × ULN; and normal cardiac function as determined
- •by MUGA (multiple-gated acquisition) scan or
- •echocardiography. All hematologic, renal, and hepatic valueshad to be within institutional normal limits in patients > 70
- •years of age. All women who had received prior chemotherapy
- •must have completed treatment at least 3 weeks prior to
- •study drug administration, and women of child-bearing age
- •had to agree to comply with effective contraception and have
- •done so since their last menses. Patients who had received
- •radiotherapy within 4 weeks of entry required special permission
- •from the study sponsors to enroll.
- •Patients were excluded if they had received a cumulative
- •lifetime dose of doxorubicin > 240 mg/m2 or epirubicin > 432
- •mg/m2, prior treatment with mitomycin-C or busulfan, or >
- •2 prior regimens of chemotherapy (excluding hormonal
- •treatment). Additional exclusion criteria included a history
- •of significant cardiac disease, arrhythmias, uncontrolled hypertension,
- •recent myocardial infarction, or ischemia. Patients
- •with human immunodeficiency virus infection, active
- •hepatitis, or a history of a serious comorbid condition, uncontrolled
- •metabolic disease, or psychiatric condition that
- •would impair tolerance or evaluation of the study drug were
- •also excluded.
排除标准
- 未提供
研究者
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