A Phase 2, MultiCenter, Randomized, Placebo-Controlled, Double-Blind, Dose Finding Study to Determine the Safety and Efficacy of SCH 619734 for the Treatment of Chemotherapy Induced Nausea and Vomiting (CINV) in Subjects Receiving Highly Emetogenic Chemotherapy (HEC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 450
- 主要终点
- The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy).
研究概览
简要总结
This is a Phase 2, randomized, multicenter, parallel-group, double-blind, placebo-controlled study of various doses of SCH 619734 in subjects receiving cisplatin-based chemotherapy. Ondansetron and dexamethasone will be concurrently administered with SCH 619734 before initiation of chemotherapy on Day 1. Subjects will record nausea and vomiting in the SPNV Subject Diary through Day 6. The quality of life assessment as measured by the Functional Living Index-Emesis Questionnaire (FLIE) will be used to measure the effect of chemotherapy-induced nausea and vomiting (CINV) on daily life. Blood samples for SCH 619734 pharmacokinetic assessments will be collected. The study is to be conducted in conformance with Good Clinical Practice.
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
- 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
- •Subject is 18 years of age or older.
- •Subject has never been treated with cisplatin and is to receive first course of cisplatin-based chemotherapy (>=70 mg/m^2).
- •Subject has a Karnofsky performance score of >=
- •Subject has a predicted life expectancy of >=3 months.
- •Subject has adequate bone marrow, kidney, and liver function as evidenced by:
- •Absolute neutrophil count >=1,500/mm3 and white blood cell count >=3,000/mm
- •Platelet count >=100,000/mm
- •Aspartate aminotransferase (AST) <=2.5 x upper limit of normal (ULN) range.
- •Alanine aminotransferase (ALT) <=2.5 x ULN.
- •Bilirubin <=1.5 x ULN, except for subjects with Gilbert's syndrome.
- •Creatinine <=1.5 x ULN.
- •Subject is able to read, understand, and complete the questionnaires.
排除标准
- •Any current treatment or medical history (eg, subject is mentally incapacitated or has a psychiatric disorder) that, in the opinion of the investigator, would confound the results of the study or pose any unwarranted risk in administering study drug to the subject.
- •Subject has contraindication to the administration of cisplatin, ondansetron, or dexamethasone including, but not limited to, a history of hypersensitivity to the drugs or their components, severe renal impairment, severe bone marrow suppression, hearing impairment, or systemic fungal infection.
- •Subject is scheduled to receive any other chemotherapeutic agent with an emetogenicity level of 3 or above (Hesketh Scale) from Day -2 through Day
- •Subject is scheduled to receive any radiation therapy to the abdomen or pelvis within 5 days prior to and/or during Days 1 through 5 following cisplatin infusion.
- •Subject has symptomatic primary or metastatic central nervous system (CNS) disease.
- •Subject has ongoing vomiting caused by any etiology or has a history of anticipatory nausea and vomiting.
研究组 & 干预措施
SCH 619734 Dose 1
干预措施: SCH 619734 Dose 1 (Drug)
SCH 619734 Dose 2
干预措施: SCH 619734 Dose 2 (Drug)
SCH 619734 Dose 3
干预措施: SCH 619734 Dose 3 (Drug)
SCH 619734 Dose 4
干预措施: SCH 619734 Dose 4 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The primary efficacy endpoint is the overall complete response rate (no emesis and no use of rescue medication from 0 through 120 hours following initiation of cisplatin-based chemotherapy).
时间窗: Days 1 through 6.
次要结局
- The key secondary efficacy endpoints are the complete response rates for the acute (0 through 24 hours) and delayed (>24 through 120 hours) phases of CINV.(Days 1 through 6.)
- The key secondary safety endpoints are adverse events, physical examinations, vital signs, electrocardiograms, and safety laboratory values.(Throughout the study and up to 30 days after the subject completes or discontinues from the study.)