临床试验/NCT00619359

NCT00619359已完成3 期

A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Cisplatin Chemotherapy

Merck Sharp & Dohme LLC0 个研究点目标入组 2,322 人开始时间: 2008年2月最近更新: 2017年3月21日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 2,322
主要终点: A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to examine the safety, tolerability, and efficacy of MK0517 to prevent Chemotherapy-Induced Nausea and Vomiting (CINV) associated with Cisplatin chemotherapy.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Prevention
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patient is male or female and is at least 18 years of age; scheduled to receive his or her first course of cisplatin chemotherapy at a dose of 70 mg/m2 or higher; predicted life expectancy of 3 months or greater
•Patient is post menopausal or, if premenopausal, must use double-barrier contraception

排除标准

•Patient has symptomatic primary or metastatic CNS malignancy
•Patient has received or will receive Radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 though Day 6
•Patient has vomited in the 24 hours prior to treatment Day 1
•Patient has an active infection; Patient uses illicit drugs or has current evidence of alcohol abuse
•Patient is pregnant or breast feeding

研究组 & 干预措施

1

Experimental

Arm 1: study medication

干预措施: Dexamethasone (Drug)

1

Experimental

Arm 1: study medication

干预措施: Ondansetron (Drug)

2

Active Comparator

Arm 2: Active comparator

干预措施: Dexamethasone (Drug)

2

Active Comparator

Arm 2: Active comparator

干预措施: Ondansetron (Drug)

结局指标

主要结局

A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).

时间窗: Overall (in the 120 hours following initiation of cisplatin chemotherapy).

The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy.

次要结局

A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).(Delayed phase (25 to 120 hours following initiation of cisplatin).)
No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)(Overall (the 120 hours following initiation of cisplatin chemotherapy))

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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