Efficacy and Safety of Palonosetron HCl Buccal Film Versus IV Palonosetron for Prevention of Chemotherapy-induced Nausea and Vomiting in Cancer Patients Receiving Moderately Emetogenic Chemotherapy
试验速览
- 阶段
- 3 期
- 入组人数
- 328
- 试验地点
- 13
- 主要终点
- Complete response
研究概览
简要总结
The phase 3 study is to compare the efficacy and safety of palonosetron, a long-acting 5-HT3 receptor antagonist, by buccal film delivery compared to IV injection for the prevention of chemotherapy-induced nausea and vomiting. Subjects receive a single dose of palonosetron prior to moderately emetogenic chemotherapy.
详细描述
This is a phase 3 randomized, double-blind, parallel group study designed to evaluate the efficacy and safety of palonosetron HCL buccal film versus IV palonosetron for the prevention of chemotherapy-induced nausea and vomiting in cancer patients receiving moderately emetogenic chemotherapy (MEC).
Subjects are randomized into two treatment groups, one with the experimental study drug palonosetron in buccal film, the other one with the control treatment using Palonosetron hydrochloride IV injection. Palonosetron PK will be assessed in a subgroup of each treatment group (two sample points, 10% of subjects).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female, at least 18-years of age;
- •Provide written informed consent;
- •Chemotherapy naïve subject with histologically or cytologically confirmed malignant disease; or chemotherapy non-naïve subject with histologically proven diagnosis of cancer;
- •Karnofsky index ≥ 50;
- •Be scheduled to receive MEC to be administered on Day 1;
排除标准
- •Unable to understand or cooperate with study procedure；
- •Received any investigational drug 30 days prior to study entry；
- •Used any drug with anti-emetic efficacy 24 hours prior to treatment and during the study；
- •Enrollment in a previous study with palonosetron；
- •Seizure disorder requiring anticonvulsant medication;
- •Experienced any vomiting, retching, or NCI Common Toxicity Criteria grade 2 or 3 nausea in the 24 hours preceding chemotherapy；
- •Ongoing vomiting from any organic etiology；
- •Experienced nausea (moderate to severe or vomiting following any previous chemotherapy)；
- •Scheduled to receive moderately or highly-emetogenic chemotherapy or radiotherapy during the study；
- •Known contraindication to 5-HT3 antagonist or dexamethasone；
- •Scheduled to receive bone marrow or stem cell transplant during study;
- •Symptomatic primary or metastatic CNS malignancy;
- •Lactating female.
研究组 & 干预措施
Palonosetron HCl Buccal Film
Palonosetron HCl Buccal Film 0.5 mg 1 hr before administration of moderately emetogenic chemotherapy and normal saline injection 30 minutes before administration of moderately emetogenic chemotherapy
干预措施: Palonosetron HCl Buccal Film 0.5 mg (Drug)
Palonosetron IV Injection
Placebo buccal film 1 har before administration of moderately emetogenic chemotherapy and Palonosetron HCl Injection 0.25 mg 30 min before administration of moderately emetogenic chemotherapy
干预措施: IV Palonosetron 0.25 mg (Drug)
结局指标
主要结局
Complete response
时间窗: During the first 24 hours after chemotherapy
No emetic episode and no rescue medication
次要结局
- Absence of nausea(up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy)
- Complete control(up to 24 hours post chemotherapy, 24-120 hours post chemotherapy, and up to 120 hours post chemotherapy)
- Complete response(up to 120 hours after chemotherapy)
- Number of emetic episodes(up to 120 hours after chemotherapy)