NCT00503386已完成2 期
A Phase II,Multicenter,Randomized,Double-blind,Cross-over Study of Palonosetron Compared With Granisetron in Prevention of Chemotherapy-induced Nausea and Vomiting in Asian Population
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 7
- 主要终点
- Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)
研究概览
简要总结
The purpose of this study is to determine whether palonosetron is tolerate and effective in preventing chemotherapy-induced nausea and vomiting in oriental population. The study is comparing the safety and efficacy of palonosetron with granisetron, a frequently used antiemetic in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age ≥ 18 yrs and <70 yrs with histologically or cytologically confirmed
- •Malignant disease
- •Naive or nonnaive to chemotherapy, with a Karnofsky score of ≥ 60
- •Scheduled to receive two courses of moderately emetogenic chemotherapy or cisplatin 60 ~ 80 mg/m2 on study Day 1
- •Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
- •Patients with hepatic, renal, or cardiovascular impairment eligible at the investigator's discretion
- •Patients experiencing, at maximum, mild nausea after previous chemotherapy eligible at the investigator's discretion
- •Predicted life expectancy of ≥ 3 months
- •Provision of written informed consent.
排除标准
- •Inability to understand or cooperate with study procedures
- •Receipt of investigational drugs ≤ 30 days before study entry
- •Receipt of other investigational drugs during the course of this study
- •Seizure disorder or any condition requiring anticonvulsants, sedatives
- •CNS malignancy or metastasis
- •Ongoing emesis due to obstruction of digestive tract
- •Emesis, retching, or Grade 2 or 3 nausea 24 hrs before chemotherapy
- •Moderate or severe nausea and vomiting after any previous chemotherapy
- •Scheduled receipt of any chemotherapeutic agent with an emetogenicity level >3 during study Days 2-5
- •Scheduled receipt of radiotherapy of the upper abdomen or cranium on study Days 2-5
- •Scheduled to receive any other drug with potential antiemetic efficacy within 24 h of study initiation and throughout day 5
- •Contraindications to 5-HT3 receptor antagonists
- •Contraindications to chemotherapy
结局指标
主要结局
Complete Protection from Vomiting (ie.Complete Response in Preventing Vomiting)
时间窗: 0-24h, 24-120h , 0-120h following chemotherapy
次要结局
- Major Protection from vomiting(0-24h,24-120h,0-120h following chemotherapy)
- Major Protection from nausea(0-24h,24-120h,0-120h following chemotherapy)
- Complete Protection from Both Vomiting and Nausea(0-24h,24-120h,0-120h following chemotherapy)
- Complete Protection from Both Vomiting and Moderate-to-Severe nausea(0-24h,24-120h,0-120h following chemotherapy)
- Time to First Emetic Episode(0-120h following chemotherapy)
研究者
研究点 (7)
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