A Multicenter, Open-Label, Single-Arm Evaluation of Palonosetron for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Subjects Who Have Experienced CINV(Chemotherapy-Induced Nausea and Vomiting) During the Previous Cycle of Low Emetogenic Chemotherapy (LEC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Eisai Inc.
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1
研究概览
简要总结
This study is designed to assess the safety and efficacy of palonesetron in preventing chemotherapy-induced nausea and vomiting (CINV) when administered to participants who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.
详细描述
Palonosetron is currently approved for prevention of acute and delayed nausea and vomiting associated with initial and repeat CINV caused by moderate and highly emetogenic chemotherapy. This study is designed to assess the safety and efficacy of palonesetron in preventing CINV when administered to patients who have experienced either vomiting and or at least moderate nausea during their last cycle of low emetogenic chemotherapy.
Palonosetron will be given intravenously approximately 30 minutes prior to the start of the chemotherapy regimen. Efficacy and safety including episodes of nausea, retching and or vomiting will be assessed over five 24 hour periods starting on Day 1 and ending on Day 6 in patient diaries. On Day 2 and Day 6 a FLIE (Functional Living Index- Emesis) assessment will also be completed in order to help evaluate the patient's quality of life from the start of the chemotherapy cycle through Day 6.
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
- 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
All Participants: Palonosetron 0.25 mg/5 mL
Participants will receive palonosetron 0.25 milligram (mg) per (/) 5 milliliter (mL) intravenous injection 30 minutes prior to receiving a low emetogenic chemotherapy (LEC) agent on Day 1.
干预措施: palonesetron (Drug)
结局指标
主要结局
Percentage of Participants With Complete Response (CR) During Acute Period (0 to 24 Hours) After Receiving Treatment on Day 1
时间窗: From 0 to 24 hours after receiving treatment on Day 1
CR was defined as the participants without any emetic episodes and did not use any rescue medication during acute period (0-24 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
Percentage of Participants With CR During Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1
时间窗: From 0 to 120 hours after receiving treatment on Day 1
CR was defined as the participants without any emetic episodes and did not use any rescue medication during overall period (0-120 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
Percentage of Participants With CR During Delayed Period (24 to 120 Hours) After Receiving Treatment on Day 1
时间窗: From 24 to 120 hours after receiving treatment on Day 1
CR was defined as the participants without any emetic episodes and did not use any rescue medication during delayed period (24-120 hours). An emetic episode was defined as 1) one occurrence of vomiting, or 2) a sequence of occurrences in very close succession not relieved by a period of relaxation of at least 1 minute, any number of occurrences of unproductive emesis (retches) in a unique 5-minute period, or 3) an episode of retching of less than 5 minute duration combined with vomiting not relieved by a period of relaxation of at least 1 minute. Participants who completed the diary for a given period and had no emetic episodes and no use of rescue medication were considered to have achieved CR, during the period.
次要结局
- Percentage of Participants With CR at Each 24 Hour Interval After Receiving Treatment on Day 1(From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1)
- Percentage of Participants With No Emetic Episodes During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1(From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1)
- Mean Change From Follow Up Period (Day 2-5) in Scores on Functional Living Index-Emesis [FLIE] Assessment Questionnaires to the End of Study (Day 8)(From (Day 2-5) to the End of Study (Day 8))
- Percentage of Participants With Complete Control at Each 24 Hours Interval After Receiving Treatment on Day 1(From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1)
- Percentage of Participants With Nausea Based on Severity and Intensity During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1(From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1)
- Percentage of Participants With CR During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1(From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1)
- Percentage of Participants With Nausea Based on Severity and Intensity During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1(From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1)
- Percentage of Participants With Complete Control During Acute Period (0 to 24 Hours), Delayed Period (24 to 120 Hours), and Overall Period (0 to 120 Hours) After Receiving Treatment on Day 1(From 0 to 24 hours, 24 to 120 hours, and 0 to 120 hours after receiving treatment on Day 1)
- Percentage of Participants With No Emetic Episodes During 0 to 48 Hours, 0 to 72 Hours, and 0 to 96 Hours After Receiving Treatment on Day 1(From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1)
- Percentage of Participants With Nausea Based on Severity and Intensity At Each 24 Hours Interval After Receiving Treatment on Day 1(From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1)
- Percentage of Participants With Complete Control During 0 to 48, 0 to 72, and 0 to 96 Hours After Receiving Treatment on Day 1(From 0 to 48 hours, 0 to 72 hours, and 0 to 96 hours after receiving treatment on Day 1)
- Percentage of Participants With No Emetic Episodes At Each 24 Hours Interval After Receiving Treatment on Day 1(From 0 to 24 hours, 24 to 48 hours, 48 to 72 hours, 72 to 96 hours and 96 to 120 hours after receiving treatment on Day 1)