PER-109-07已完成未知
A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP, STUDY OF INTERNAL BLIND CONDITIONS, TO DETERMINE THE EFFECTIVENESS AND TOLERABILITY OF APREPITANT FOR THE PREVENTION OF THE NAUSEA AND VOMITING INDUCED BY CHEMOTHERAPY ASSOCIATED WITH THE MODERATELY EMETOGENIC CHEMOTHERAPY (STUDY # 2)
MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2008年1月8日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
- 0 至 0（—）
入选标准
- •The patient is male or female, and is> 18 years of age;
- •The patient suffers from a malignant disease histologically or cytologically confirmed. Note: The number of patients with breast cancer will be limited to approximately 50% of the total enrollment.
- •The patient is able to understand the study procedures and agrees to participate in the study by providing written informed consent.
- •The patient has not undergone moderate or highly emetogenic chemotherapy according to Hesketh.
- •The patient is scheduled to receive a single dose of one or more of the following moderately emetogenic chemotherapeutic agents on Day 1 of Treatment: Any IV dose of: oxaliplatin, carboplatin, epirubicin, idarubicin, ifosfamide, irinotecan, daunorubicin, doxorubicin Cyclophosphamide IV (<1500 mg / m2), Cytarabine IV (> lg / m2).
- •The patient has a predicted life expectancy> 4 months.
- •The patient has a Karnofsky score> 60 (see Appendix 6.4).
- •The patient can read, understand and complete the study questionnaires
排除标准
- •The patient suffers from a malignancy of the primary CNS or symptomatic metastasis.
- •The patient is scheduled to receive any dose of cisplatin.
- •The patient has received or will receive radiation therapy in the abdomen or pelvis in the week before the period from Day I to Day 6 of the Treatment.
- •The patient has vomited in the 24 hours prior to Day 1 of the Treatment.
- •The patient has a history of treatment with moderate or high emetogenic chemotherapy according to Hesketh
- •The patient has an active infection (for example, pneumonia) or any uncontrolled disease (for example, diabetic ketoacidosis, gastrointestinal obstruction) with the exception of a malignancy that, in the opinion of the researcher, could confuse the results of the study or represent a unjustified risk.
- •The patient currently consumes any illicit drug, such as marijuana, or presents current evidence of alcohol abuse, as determined by the investigator.
- •The patient is mentally impaired or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, prevents them from entering the study.
- •The patient has a history of a disease that, in the opinion of the investigator, could confuse the results of the study or represent an unjustified risk.
- •The patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone
- •The patient is pregnant or breastfeeding. (Potentially fertile patients are required to show a negative urine pregnancy test before entering the study).
- •The patient has participated in a study with aprepitant or has taken an unapproved (investigational) pill within the last 4 weeks.
研究者
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