CTRI/2013/05/003629招募中4 期
Observational study to assess the Efficacy and Safety of Aprepitant for the prevention of nausea and vomiting associated with HEC/ MEC regimens
Glenmark Pharmaceuticals ltd0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Male and female subjectâ??s >= 18 years of age.
- •Patients with either MEC or HEC regimens
- •Patients with histologically confirmed malignancies
- •Karnofsky scores >= 60
- •Predicted life expectancy >= 4 months
排除标准
- •Any concomitant condition that, in the opinion of the investigator, would preclude an evaluation of a response or make it unlikely that the contemplated course of therapy could be completed
- •Patients with symptomatic primary or metastatic central nervous system malignancy
- •Patients who had received or were to receive radiation therapy to the abdomen or pelvis in the week prior to treatment
- •Patients who had vomited in the 24 hr prior to treatment
- •Patients who had an active infection or any uncontrolled disease other than malignancy
- •Abnormal laboratory values (absolute neutrophil count 1,500/mm3, white blood cell count 3,000/mm3, platelet count 100,000/mm3, aspartate transaminase 2.5Ã? upper limit of normal, alanine transaminase 2.5Ã? upper limit of normal, bilirubin 1.5Ã? upper limit of normal, creatinine 1.5Ã? upper limit of normal).
- •Patients taking systemic steroid therapy at any dose
研究者
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