NCT00952341已完成3 期
A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With High-Dose Cisplatin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 421
- 主要终点
- Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
研究概览
简要总结
This study will demonstrate and confirm the efficacy and safety of MK0869 for the treatment of chemotherapy-induced nausea and vomiting in Chinese patients.
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 (Participant, Investigator)
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
- •Patient is scheduled to receive his/her first course of cisplatin chemotherapy at a dose of at least 70 mg/m^2 administered a maximum of 3 hours
- •Patient has a predicted life expectancy of at least 3 months
- •Patient is not pregnant
- •Cycle 2 (optional):
- •Participation in the study during the next cycle of chemotherapy is considered
- •appropriate by the investigator and will not pose unwarranted risk to the patient.
- •Satisfactory completion of the preceding cycle of chemotherapy and related
- •study procedures.
- •Patient will continue to receive the same chemotherapy regimen as in Cycle
- •The cisplatin dose may be reduced in subsequent cycle, as long as the new
- •dose is still no less than 70 mg/m^2.
排除标准
- •Cycles 1 & 2:
- •Patient will receive stem cell therapy in conjunction with cisplatin
- •Patient has an active infection or any uncontrolled disease (e.g. diabetes)
- •Patient will receive multiple-day chemotherapy with cisplatin
- •Patient will receive chemotherapy of moderate or high emetogenicity on the 6 days prior to cisplatin infusion or the 6 days following the cisplatin infusion
- •Patient has vomited within 24 hours prior to cisplatin infusion
- •Patient received or will receive radiation therapy to the abdomen
研究组 & 干预措施
Aprepitant (MK-0869)
Experimental
干预措施: aprepitant (Drug)
Aprepitant (MK-0869)
Experimental
干预措施: granisetron (Drug)
Aprepitant (MK-0869)
Experimental
干预措施: dexamethasone (Drug)
Standard Therapy
Placebo Comparator
干预措施: dexamethasone (Drug)
Standard Therapy
Placebo Comparator
干预措施: granisetron (Drug)
结局指标
主要结局
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
时间窗: 0 to 120 hours
Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.
次要结局
- Time to First Vomiting Episode in Cycle 1(0 to 120 hours)
- Proportion of Participants With No Impact on Daily Life in Cycle 1(0 to 120 hours)
- Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1(0 to 120 hours)
- Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1(0 to 24 hours)
- Proportion of Participants With Complete Response in the Acute Phase of Cycle 1(0 to 24 hours)
- Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1(25 to 120 hours)
- Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1(25 to 120 hours)
研究者
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