PER-017-19招募中未知
A PHASE 4, OPEN-LABEL, SINGLE ARM STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A THREE-DAY FOSAPREPITANT REGIMEN ADMINISTERED FOR THE PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING (CINV) IN PEDIATRIC PARTICIPANTS RECEIVING EMETOGENIC CHEMOTHERAPY
Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,0 个研究点目标入组 19 人开始时间: 2019年7月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 19
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Be receiving a moderately or highly emetogenic chemotherapy agent/regimen or a chemotherapy agent/regimen not previously tolerated due to vomiting. See Appendix 8 for guidance on the classification of the emetogenicity of chemotherapeutic agents and regimens.
- •2. Have a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age) as defined in Appendix 9.
- •3. Have a preexisting functional central venous catheter available for study intervention administration.
- •4. Be fosaprepitant naïve.
- •5. Have a predicted life expectancy ≥3 months.
- •6. Be male or female.
- •7. Be from 6 months to 17 years of age (inclusive) at the time of allocation.
- •8. Weigh at least 6 kg.
- •9. Have parent/legal guardian (legally authorized representative) agreement to the participant’s participation as indicated by parent/legal guardian signature on the ICF. Participants 12 to 17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled study visits.
- •10. Have completed the preceding study cycle, have no unresolved drug-related AEs, and continued participation in an optional cycle poses no unwarranted risk to the participant as determined by the investigator.
- •11. Have parent/legal guardian (legally authorized representative) or participant (if participant is 18 years old) agreement to the participant’s participation as indicated by parent/legal guardian or participant (if participant is 18 years old) signature on the ICF for the optional cycles. Participants 12 to 17 years of age, or as required by local regulation, assents and has the ability to understand the nature and intent of the study including the ability to comply with study procedures and is willing to keep scheduled study visits.
- •Please refer to the protocol for more information
排除标准
- •1. Has abnormal laboratory values as follows:
- •-peripheral absolute neutrophil count (ANC) <1000/mm3
- •-platelet count <75,000/mm3
- •-aspartate aminotransferase (AST) >5.0 × upper limit of normal (ULN) for age
- •-alanine aminotransferase (ALT) >5.0 × ULN for age
- •-bilirubin >1.5 × ULN for age
- •-creatinine >1.5 × ULN for age
- •2. Will receive stem cell rescue therapy in conjunction with a study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant.
- •3. Is currently a user of any recreational or illicit drugs or has current evidence of drug or alcohol abuse or dependence as determined by the investigator.
- •4. Is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- •5. Is pregnant or breast feeding.
- •6. Is allergic to fosaprepitant, aprepitant, or prescribed 5-HT3 antagonist.
- •7. Has an active infection (eg, pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (eg, diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy, or has any illness which in the opinion of the investigator, might confound the results of the study or pose unwarranted risk in administering study intervention or concomitant therapy to the participant.
- •8. Is a WOCBP who has a positive urine pregnancy test at screening (Cycle 1) or on Day 1 of optional Cycles 2 or 3. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- •9. Has been started on systemic corticosteroid therapy within 72 hours prior to study intervention administration or is expected to receive a corticosteroid as part of the chemotherapy regimen.
- •10. Has received any medication within the timeframes listed in Table 1 or needs to receive any medication listed in Table 1 during the time period specified relative to the last dose of fosaprepitant in a given cycle (see Protocol)
- •11. Has ever participated in a previous study of aprepitant or fosaprepitant or has taken a non-approved (investigational) drug within the last 4 weeks.
- •12. Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation.
- •Please refer to the protocol for more information
研究者
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