EMEND® IV In Salvage Treatment of Chemotherapy-Induced Vomiting
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 111
- 主要终点
- Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy
研究概览
简要总结
This study will assess the efficacy of a single dose of intravenous (IV) fosaprepitant (MK-0517, EMEND® IV) as salvage therapy when added to a 5-hydroxytryptamine receptor 3 antagonist (5-HT3 RA) and dexamethasone for the prevention of chemotherapy-induced vomiting (CIV) in participants who experienced CIV in the first cycle of moderately emetic chemotherapy (MEC). The primary hypothesis is that there will be no vomiting and no retching in at least 20% of participants during the second cycle of MEC in participants who previously experienced vomiting during the first cycle of MEC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with either breast or gynecological cancer
- •Receiving either AC-like or CT MEC
- •Experienced at least 1 episode of vomiting or retching during the first 5 days following Cycle 1 of chemotherapy that was thought to be due to chemotherapy. Received standard chemotherapy-induced nausea and vomiting (CINV) prophylaxis not containing aprepitant or fosaprepitant
- •No change in chemotherapy at Cycle 2
- •No change in Cycle 1 antiemetic regimen at Cycle 2
- •Eastern Cooperative Oncology Group (ECOG) status 0-1
排除标准
- •Requires increase in systemic corticosteroid therapy
- •Used benzodiazepines or opiates in the 48 hours prior to Cycle 2 chemotherapy
- •Received or will receive radiation therapy to the abdomen or pelvis in the week prior to Visit 1 or in Days 1-6 following chemotherapy
- •Vomited in the 24 hours prior to Treatment Day 1
- •Pregnant or breast-feeding
- •Participating in a study with aprepitant or fosaprepitant or has taken an investigational drug in the last 4 weeks
- •Symptomatic central nervous system metastasis
- •History of other malignancies in the last 2 years
研究组 & 干预措施
Fosaprepitant 150 mg
Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
干预措施: Fosaprepitant dimeglumine (Drug)
Fosaprepitant 150 mg
Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
干预措施: 5-HT3 RA (Drug)
Fosaprepitant 150 mg
Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
干预措施: Dexamethasone (Drug)
Fosaprepitant 150 mg
Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
干预措施: Rescue medication (Drug)
结局指标
主要结局
Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy
时间窗: Up to 120 hours following initiation of chemotherapy in Cycle 2
A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retching (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are separated by the absence of emesis and retching for at least one minute. The date and time of each vomiting episode was recorded by participants in diaries at the time of occurrence. The percentage of partcipants with no vomiting and no retching episodes 0-120 hours following chemotherapy in Cycle 2 was calculated.
次要结局
- Percentage of Participants With No Vomiting and No Retching During Cycle 2 of Chemotherapy Per Type of Chemotherapy(Up to 120 hours following initiation of chemotherapy in Cycle 2)
- Percentage of Participants With a Complete Response During Cycle 2 of Chemotherapy(Up to 120 hours following initiation of chemotherapy in Cycle 2)
- Functional Living Index - Emesis (FLIE) Total Score During Cycle 2 of Chemotherapy(From Day 1 (prior to initiation of chemotherapy in Cycle 2) to morning of Day 6 (up to ~120 hours following initiation of chemotherapy in Cycle 2))
- Percentage of Participants With No Significant Nausea During Cycle 2 of Chemotherapy(From 24 to 120 hours following initiation of chemotherapy in Cycle 2)
- Percentage of Participants Who Used No Rescue Medication During Cycle 2 of Chemotherapy(Up to 120 hours following initiation of chemotherapy in Cycle 2)