A Korean Multicenter, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies (MEC, Non-AC Regimes) With Broad Range of Tumor Types (KMEC Study)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 494
- 主要终点
- The Percentage of Participants With No Vomiting - Overall Stage
研究概览
简要总结
This is an efficacy and safety study to compare aprepitant with ondansetron for the prevention of nausea and vomiting in the first cycle of moderately emetogenic chemotherapy (MEC) in participants with solid tumors. MECs include a number of commonly used cancer chemotherapeutic drugs including: oxaliplatin-based, irinotecan-based, and carboplatin-based regimens.
The primary hypothesis of this study is that the Aprepitant Regimen is superior to the Control (ondansetron) Regimen with respect to the percentage of participants with No Vomiting Overall (in the 120 hours following initiation of MEC) in participants with solid tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed malignant disease
- •Scheduled to receive a single dose of one or more of moderately emetogenic chemotherapeutic agents during Cycle 1
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2 or Karnofsky score ≥60
- •Predicted life span ≥4 months
- •Laboratory values demonstrating adequate hematologic status
- •Premenopausal females must not be pregnant or lactating and must agree to use effective birth control
排除标准
- •Received chemotherapy within 6 months prior to starting on study drugs
- •Scheduled to receive subsequent treatment due to a refractory response to first or second line chemotherapy
- •Received an investigational drug within 30 days prior to starting on study drugs
- •Radiation therapy to the abdomen or pelvis in the week prior to starting on study drugs
- •Vomiting in the 24 hours prior to starting on study drugs
- •Active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy
- •Known hypersensitivity to Aprepitant (EMEND®), Dexamethasone or 5-HT3 receptor antagonists
- •Presentation with gastrointestinal obstruction symptoms
- •Symptomatic primary or metastatic central nervous system malignancy
研究组 & 干预措施
Aprepitant Regimen
Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
干预措施: Aprepitant (Drug)
Aprepitant Regimen
Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
干预措施: Ondansetron (Drug)
Aprepitant Regimen
Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
干预措施: Dexamethasone (Drug)
Aprepitant Regimen
Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
干预措施: Ondansetron Placebo (Drug)
Aprepitant Regimen
Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
干预措施: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride). (Drug)
Control Regimen
Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
干预措施: Aprepitant Placebo (Drug)
Control Regimen
Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
干预措施: Ondansetron (Drug)
Control Regimen
Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
干预措施: Dexamethasone (Drug)
Control Regimen
Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
干预措施: Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride). (Drug)
结局指标
主要结局
The Percentage of Participants With No Vomiting - Overall Stage
时间窗: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC).
次要结局
- Number of Emetic Events - Overall Stage(Hour 0 on Day 1 to Day 5 (approximately 120 hours))
- Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages(Hour 0 on Day 1 to Day 5 (approximately 120 hours))
- Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage(Days 1 to Day 5)
- Percentage of Participants With No Impact on Daily Life - Overall Stage(Day 6)
- Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages(Day 1 to Day 5)
- Percentage of Participants With One or More Clinical Adverse Event(Day 1 through Day 29 (Up to 28 days after first dose of study drug))
- Percentage of Participants With No Vomiting - Acute and Delayed Stages(Day 1, Day 2 to Day 5)