A Randomized, Dose-ranging, Open-label, Parallel Group Study to Assess the Efficacy, Safety and Pharmacokinetics of Palonosetron HCl Buccal Film Versus IV Palonosetron 0.25 mg for the Prevention of CINV in Cancer Patients Receiving MEC
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 7
- 主要终点
- Complete Acute Response
研究概览
简要总结
Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film delivery compared to iv injection for chemotherapy induced nausea or vomiting (CINV). Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.
详细描述
This is a Phase 2 study to compare efficacy, safety and PK of palonosetron, a long acting 5-HT3 receptor antagonist, by buccal film compared to iv injection for moderately emetogenic chemotherapy-induced nausea or vomiting (CINV) in cancer patients. Subjects are randomized into three treatment groups, two with the experimental study drug palonosetron in buccal film at one of two different doses or the control treatment using Palonosetron hydrochloride iv injection. Palonosetron PK will be assessed in a subgroup of each treatment group.
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
- 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
- •With histologically or cytologically confirmed malignant disease;
- •. Be scheduled to receive the first course of MEC to be administered on Day 1
- •Using reliable contraceptive measures;
- •negative serum pregnancy test (if potentially child bearing)
排除标准
- •Received investigational drugs within 30 days before the start of study treatment or scheduled to receive a highly or moderately emetogenic chemotherapeutic agent;
- •Have a clinically unstable seizure disorder with seizure activity requiring anticonvulsant medication;
- •Have severe renal or hepatic impairment;
- •Have positive serology test results;
- •Have a known contraindication to 5-HT3 receptor antagonists;
- •Treated with commercially available or investigative palonosetron formulation within 2 weeks prior to start of study treatment;
- •Allergic to palonosetron or any other 5-HT3 antagonist;
- •Currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence as determined by the investigator;
- •Will be receiving stem cell rescue therapy in conjunction with study related course of emetogenic chemotherapy;
- •Received or will receive total body irradiation or radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period.
研究组 & 干预措施
A (Buccal 0.25 Mg)
Palonosetron HCl Buccal Film 0.25 Mg
干预措施: Palonosetron Hydrochloride Buccal Film 0.25 Mg (Drug)
B (Buccal 0.5 Mg)
Palonosetron HCl Buccal Film 0.5 Mg
干预措施: Palonosetron Hydrochloride Buccal Film 0.5 Mg (Drug)
C (IV Injection 0.25 Mg)
IV palonosetron 0.25 Mg (ALOXI®)
干预措施: Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution (Drug)
结局指标
主要结局
Complete Acute Response
时间窗: first 24 hours after chemotherapy
no emetic episode and no rescue medication during the first 24 hours after chemotherapy
次要结局
未报告次要终点