A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination With Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 722
- 试验地点
- 113
- 主要终点
- Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
研究概览
简要总结
This study was designed to assess the safety and efficacy of different dosages and administration schedules of an investigational agent administered over 3 days when added to standard therapy used in the prevention of chemotherapy-induced nausea and vomiting in cancer patients. Subjects will be asked to complete daily diaries while on study medication. In addition subjects will be required to return to the investigational site several times during the course of the study for follow up safety assessments which may include blood samples for hematology and chemistry evaluations as well as physical exams. A final assessment will be preformed on study Day 20-30 at which time the subject will complete the study.
详细描述
A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination with Ondansetron Hydrochloride and Dexamethasone for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Moderately Emetogenic Chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
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
- •Willing to provide a written informed consent prior to receiving any study-specific procedures or assessments.
- •Diagnosed with a solid malignant tumor and has not previously received chemotherapy.
- •Scheduled to receive chemotherapy conducive to regimens outlined in the study protocol.
排除标准
- •Not received any investigational product within 30 days of enrollment into the study.
- •Must not be pregnant.
- •Must not be of childbearing potential or is willing to use specific barrier methods outlined in the protocol.
- •Must not be scheduled to receive radiation therapy to the abdomen or to the pelvis within seven (7) days prior to starting study medication.
- •Must not be currently under treatment for a condition which may cause nausea or vomiting (i.e., active peptic ulcer disease, gastric obstruction).
- •Must not have a history of peptic ulcer disease.
结局指标
主要结局
Based on the number of subjects who do not experience vomiting, retching or nausea over a 5 day period following the initiation of chemotherapy.
次要结局
- Based on routine physical exam findings, vital signs, routine clinical laboratory tests, clinical monitoring and/or observation, and adverse events reporting performed during scheduled visits.