Pilot Study of Fosaprepitant (MK-0517) for Breakthrough Chemotherapy Induced Nausea and Vomiting
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale
研究概览
简要总结
RATIONALE: Antiemetic drugs, such as fosaprepitant dimeglumine, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.
PURPOSE: This clinical trial is studying the side effects of fosaprepitant dimeglumine and to see how well it works in treating patients with nausea and vomiting caused by chemotherapy.
详细描述
OBJECTIVES:
Primary
- To evaluate the efficacy and safety of fosaprepitant dimeglumine in patients with breakthrough chemotherapy-induced nausea and vomiting (CINV) after failing prophylactic antiemetic therapy.
Secondary
- To evaluate toxicity and serious adverse events associated with this regimen in these patients.
- To evaluate the ability of patients to tolerate oral intake.
- To evaluate the health-related quality of life of patients treated with this regimen.
- To evaluate specific side effects associated with this regimen, including pain sensation and/or soreness at the infusion site, headache, dizziness, and somnolence, in these patients .
- To refine the study design for future phase II and III studies of rescue therapy for breakthrough CINV using various secondary endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Fosaprepitant
干预措施: fosaprepitant dimeglumine (Drug)
Fosaprepitant
干预措施: systemic chemotherapy (Drug)
Fosaprepitant
干预措施: survey administration (Other)
Fosaprepitant
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Improvement in Nausea Score From Baseline to 2 Hours as Assessed by the Numerical Visual Analogue Scale
时间窗: Baseline to 2 hours after study drug administered.
The outcome measure is the number of participants that self report improvement in a nausea score from baseline, prior to fosaprepitant, to 2 hours post dose. This includes only participants who report breakthrough nausea or vomiting after chemotherapy and after receiving prophylactic anti-emetics. The primary outcome is measured using the visual analogue scale, a self report scale from "No Nausea" to "Nausea as bad as it can be"; a value can be indicated anywhere on this scale using a free hand mark by the participant and gauged with ruler by study staff. Any participant that reported a lower value on the scale 2 hours from baseline would be considered in this outcome measure.
次要结局
- Improvement in Nausea Score From Baseline to 12 Hours(Baseline to 12 hours after study drug administered.)
- Improvement in Nausea Score From 2 Hours to 24 Hours(2 hours to 24 hours after study drug administered.)
- Number of Participants Who Experienced Vomiting Episodes From Baseline to 24 Hours(Baseline to 24 hours after study drug administered.)
- Participants Who Required the Use of Second Rescue Drug (Time to Treatment Failure)(2 hours after administration of Fosaprepitant 150 mg IV)
- Participants Achieving a Complete Response (no Emesis, no Additional Rescue Medication Required)(up to 24 hours after receiving fosaprepitant)
- Participants With Increased Fatigue or Sedation Within 24 Hours After Receiving Fosaprepitant(up to 24 hours after study drug administered.)
- Participants With Specific Side Effects, Including Pain Sensation/Soreness at the Infusion Site, Headache, and Dizziness(up to 24 hours after study drug administered.)
研究者
Joseph Bubalo
PharmD
OHSU Knight Cancer Institute