A Phase III Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Efficacy and Safety of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant, Administered in Combination With ZOFRAN and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-Based Chemotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 810
- 试验地点
- 81
- 主要终点
- Number of participants who achieved complete response
研究概览
简要总结
This is a Phase III trial designed to demonstrate that casopitant when added to dexamethasone and ondansetron is more effective in the prevention of vomiting then dexamethasone and ondansetron alone, in patients who receive a cisplatin-based highly emetogenic chemotherapy.
详细描述
A Phase III Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group Study of the Efficacy and Safety of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist, Casopitant, administered in Combination with ZOFRAN and Dexamethasone for Prevention of Chemotherapy-Induced Nausea and Vomiting in Cancer Subjects Receiving Highly Emetogenic Cisplatin-Based Chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
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
结局指标
主要结局
Number of participants who achieved complete response
时间窗: Up to 120 hours of cycle 1 of HEC
Complete response was defined as no vomiting/retching and no rescue therapy) over the first 120 hours following the initiation of their first cycle of a cisplatin-based HEC regimen. Vomiting was defined as the forceful expulsion of gastrointestinal contents through the mouth or nose. Retching was defined as the labored, spasmodic, rhythmic contraction of the respiratory and abdominal muscles in an attempt to vomit, that was not productive of gastrointestinal contents (also known as "dry heaves").
次要结局
- Number of participants who use of anti-emetic rescue medication(Up to 120 hours of each HEC cycle (up to 24 months))
- The willingness of participant to use the same treatment during future chemotherapy, as assessed by the participant willingness questionnaire(Up to 120 hours of each HEC cycle (up to 24 months))
- Number of participants who achieved complete response during the acute (0-24 hours) and the delayed (24-120 hours) phase following the first cycle of HEC(Up to 120 hours of cycle 1 of HEC)
- Percentage of participants with impact on daily life activities for the first 120 hours following the first cycle of chemotherapy as assessed by the FLIE questionnaire-interpretation(Up to 120 hours of each HEC cycle (up to 24 months))
- Summary of mean systolic blood pressure (SBP) and diastolic blood pressure (DBP)(Up to end of cycle (approximately 28 days per cycle); maximum up to 24 months)
- Maximum nausea score (to assess the severity of nausea), as assessed by a visual analogue scale (VAS)(Up to 120 hours of each HEC cycle (up to 24 months))
- Number of participants with first emetic event(Up to 120 hours of each HEC cycle (up to 24 months))
- Number of participants who reported significant nausea (>=25 mm on the VAS)(Up to 120 hours of cycle 1 of HEC)
- Number of participants who achieved complete protection, defined as no vomiting/retching, no significant nausea and no rescue medication(Up to 120 hours of cycle 1 of HEC)
- Number of participants who achieved a complete response during the overall (0-120 hours) phase following subsequent cycles of HEC(Up to 120 hours of cycle of HEC 2 to 6)
- Number of participants who received anti-emetic rescue medication(Up to 120 hours of cycle 1 of HEC)
- Number of participants who vomited/retched(Up to 120 hours of cycle 1 of HEC)
- Number of participants who reported nausea (>=5 mm on the VAS)(Up to 120 hours of cycle 1 of HEC)
- Number of participants who achieved total control, defined as no vomiting/retching, no nausea and no rescue medication(Up to 120 hours of each HEC cycle (up to 24 months))
- Summary of abnormal electrocardiogram findings(Up to end of cycle (approximately 28 days per cycle); maximum up to 24 months)
- Summary of mean heart rate(Up to end of cycle (approximately 28 days per cycle); maximum up to 24 months)
- Participant satisfaction with the prophylactic anti-emetic regimens, as assessed by the participant satisfaction questionnaire(Up to 120 hours of each HEC cycle (up to 24 months))
- Number of participants with nausea as assessed by a categorical scale, over the first 120 hours following HEC(Up to 120 hours of each HEC cycle (up to 24 months))
- Number of participants with adverse events (AE) and serious adverse events (SAE)(Up to 24 month after last dose of investigational product)
- Summary of mean respiratory rate(Up to end of cycle (approximately 28 days per cycle); maximum up to 24 months)
- The impact on participants daily life activities for the first 120 hours following the first cycle of chemotherapy as assessed by the Functional Living Index-Emesis (FLIE) questionnaire-Score(Up to 120 hours of each HEC cycle (up to 24 months))
- Number of participants with abnormalities of Grade 3 and 4 in laboratory parameters (clinical chemistry and hematology)(Up to end of cycle (approximately 28 days per cycle); maximum up to 24 months)