A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetogenic Chemotherapy (MEC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 848
- 主要终点
- Number of Patients Who Reported No Vomiting
研究概览
简要总结
The study will test aprepitant for the prevention of CINV in patients receiving their initial cycle of Moderately Emetogenic Chemotherapy (MEC). Patients receiving more then one cycle of chemotherapy may opt to participate in an optional second cycle during which the patient will receive the same antiemetic regimen as cycle 1, except that an IV formulation of aprepitant will be given in place of the oral formulation on study day one. Study drug administration on subsequent days will be given orally as in cycle 1.
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
- •Patients will be naive to emetogenic chemotherapy with histologically or cytologically confirmed malignant disease scheduled to receive a single dose of moderately emetogenic chemotherapy on study day 1
- •Karnofsky score of 60 or greater
排除标准
- •Patient is scheduled to receive any dose of cisplatin
- •Patient will receive abdominal or pelvic radiation a week prior and up to 6 days after initiation of chemotherapy
- •Any allergies to study drug or antiemetics
- •Taking CYP3A4 substrates/prohibited medication
- •Significant medical or mental conditions
- •Abnormal laboratory values (platelets, absolute neutrophils, AST, ALT, bilirubin or creatinine).
研究组 & 干预措施
1
Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours.
干预措施: aprepitant (Drug)
1
Arm 1: Day 1: aprepitant 125 mg capsule; ondansetron 8 mg capsule prior to chemotherapy and 1 8mg capsule 12 hrs after first dose; dexamethasone 12 mg tablets + 2 dexamethasone Pbo tablets. Day 2: Aprepitant 80 mg capsule; Ondansetron 8 mg capsule every 12 hours Day 3: Aprepitant 80 mg capsule Ondansetron 8 mg capsule every 12 hours.
干预措施: Comparator; Placebo (unspecified) (Drug)
2
Arm 2: Day 1: Aprepitant 125 mg Pbo capsule; Ondansetron 8 mg capsule prior to chemotherapy and 8 mg capsule 12 hours after first dose; Dexamethasone 20 mg tablets. Day 2: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours; Day 3: Aprepitant 80 mg Pbo capsule; Ondansetron 8 mg capsule every 12 hours. 3 Day treatment period Optional cycle 2 is being offered to patients. Optional cycle 2 will substitute aprepitant with fosaprepitant dimeglumine 115 mg or Pbo on day 1. All other dosing regimen will remain the same as cycle 1.
干预措施: Comparator; Placebo (unspecified) (Drug)
结局指标
主要结局
Number of Patients Who Reported No Vomiting
时间窗: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.
The number of patients who reported No Vomiting in the overall phase in Cycle 1
次要结局
- Number of Patients Who Reported Complete Response(Overall phase (0-120 hours post initiation of MEC) in Cycle 1)