[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100186060":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":69,"centralContacts":56,"locations":56,"responsibleParty":73,"collaborators":56,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":56,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":56,"maxAge":84,"enrollmentInfo":85,"targetDuration":56,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":56,"overallStatus":94,"whyStopped":56,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":56},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,15,19,23,27,33,38],{"label":9,"type":10,"description":11,"interventionNames":12},"Fosaprepitant 5 mg\u002Fkg-Cycle 1","EXPERIMENTAL","Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to \\\u003C12 years old were administered 5 mg\u002Fkg (not to exceed 150 mg); participants 1 to \\\u003C4 months old were administered 2.5 mg\u002Fkg; participants 0 to \\\u003C1 month old were administered 1.25 mg\u002Fkg. Participants were also administered IV ondansetron (0.15 mg\u002Fkg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \\\u003C6 months of age), with or without dexamethasone.",[13,14],"Drug: Fosaprepitant","Drug: Ondansetron",{"label":16,"type":10,"description":17,"interventionNames":18},"Fosaprepitant 3 mg\u002Fkg-Cycle 1","Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to \\\u003C12 years old were administered a weight-adjusted dose of 3 mg\u002Fkg (not to exceed 150 mg). Participants were also administered IV ondansetron (0.15 mg\u002Fkg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \\\u003C6 months of age), with or without dexamethasone.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"Fosaprepitant 1.2 mg\u002Fkg-Cycle 1","Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to \\\u003C12 years old were administered a weight-adjusted dose of 1.2 mg\u002Fkg (not to exceed 60 mg). Participants were also administered IV ondansetron (0.15 mg\u002Fkg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \\\u003C6 months of age), with or without dexamethasone.",[13,14],{"label":24,"type":10,"description":25,"interventionNames":26},"Fosaprepitant 0.4 mg\u002Fkg-Cycle 1","Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to \\\u003C12 years old were administered a weight-adjusted dose of 0.4 mg\u002Fkg (not to exceed 20 mg). Participants were also administered IV ondansetron (0.15 mg\u002Fkg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \\\u003C6 months of age), with or without dexamethasone.",[13,14],{"label":28,"type":29,"description":30,"interventionNames":31},"Placebo Control-Cycle 1","PLACEBO_COMPARATOR","Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg\u002Fkg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \\\u003C6 months of age), with or without dexamethasone.",[32,14],"Drug: Fosaprepitant Placebo",{"label":34,"type":10,"description":35,"interventionNames":36},"Fosaprepitant 5 mg\u002Fkg-Cycles 2-6","For optional Cycles 2-6, participants from the 5 mg\u002Fkg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg\u002Fkg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.",[13,37],"Drug: 5-hydroxytryptamine 3 antagonist",{"label":39,"type":10,"description":40,"interventionNames":41},"Fosaprepitant 3 mg\u002Fkg-Cycles 2-6","For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg\u002Fkg) or Cycle 1 control arm were administered fosaprepitant 3 mg\u002Fkg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.",[13,37],[43,52,57,64],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","Fosaprepitant","Administered intravenously (IV) as a single dose",[24,20,16,39,9,34],[49,50,51],"Fosaprepitant dimeglumine","MK-0517","EMEND® for Injection",{"type":44,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Fosaprepitant Placebo","Administered IV as a single dose",[28],null,{"type":44,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Ondansetron","Administered IV according to local labeling and\u002For local standard of care",[24,20,16,9,28],[62,63],"Ondansetron hydrochloride","Zofran® Injection",{"type":44,"name":65,"description":59,"armGroupLabels":66,"otherNames":67},"5-hydroxytryptamine 3 antagonist",[39,34],[68],"5-HT3",[70],{"name":71,"affiliation":5,"role":72},"Medical Director","STUDY_DIRECTOR",{"type":74,"investigatorFullName":56,"investigatorTitle":56,"investigatorAffiliation":56,"oldNameTitle":56,"oldOrganization":56},"SPONSOR","100186060","phase-2-study-of-the-pharmacokinetics-pharmacodynamics-safety-and-tolerability-of-fosaprepitant-for-the-prevention-of-chemotherapy-induced-nausea-and-vomiting-cinv-in-children-mk-0517-029-100186060",true,"NCT01697579","Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)","A Phase IIb, Partially-Blinded, Randomized, Active Comparator-Controlled Study to Evaluate the Pharmacokinetics\u002FPharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With Emetogenic Chemotherapy Sub-title: Open-Label Cohort to Further Evaluate the Pharmacokinetics\u002FPharmacodynamics, Safety, and Tolerability of Fosaprepitant in Pediatric Patients Birth to \u003C12 Years Old","Inclusion Criteria:\n\n* Is 0 months (at least 37 weeks gestation) to \\\u003C18 years of age\n* Scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days for a documented malignancy, or a chemotherapy regimen not previously tolerated due to vomiting\n* Expected to receive ondansetron as part of antiemetic regimen (Cycle 1); Expected to receive a 5-HT3 antagonist as part of antiemetic regimen (Cycles 2-6)\n* If female and has begun menstruating, must have a negative pregnancy test prior to study participation and agree to remain abstinent or use a barrier form of contraception\n* Predicted life expectancy of ≥3 months\n* Pre-existing functioning central venous catheter\n* Weight ≥3rd percentile for age and gender (and ≥3.0 kg)\n\nExclusion Criteria:\n\n* Vomited in the 24 hours prior study drug administration (Cycle 1)\n* Current user of any illicit drugs (including marijuana) or current evidence of alcohol abuse\n* Scheduled to receive stem cell rescue therapy in conjunction with study related course(s) of emetogenic chemotherapy\n* Received or will receive radiation therapy to the abdomen or pelvis in the week prior to study drug administration and\u002For during the course of the study\n* Pregnant or breast feeding\n* Allergic to fosaprepitant, aprepitant, ondansetron, or any other 5-HT3 antagonist\n* Has a symptomatic central nervous system (CNS) tumor causing nausea and\u002For vomiting\n* Has an active infection, congestive heart failure, slow heart rate, or other uncontrolled disease other than cancer\n* Mentally incapacitated or has a significant emotional or psychiatric disorder\n* Known history of QT prolongation or is taking any medication known to lead to QT prolongation\n* Taking other excluded medications\n* Participated in any previous study of aprepitant or fosaprepitant, or taken an investigational drug within 4 weeks prior to study participation",false,"ALL","17 Years",{"count":86,"type":87},240,"ACTUAL","INTERVENTIONAL",[90],"PHASE2","The purpose of this study was to determine the appropriate dosing regimen of fosaprepitant, when administered with ondansetron (with or without dexamethasone), for the prevention of CINV in children from birth to \\\u003C17 years of age. Fosaprepitant is a prodrug to aprepitant. All participants who completed the randomized Cycle 1 could elect to receive open-label fosaprepitant during optional Cycles 2-6.",[93],"Chemotherapy-induced Nausea and Vomiting","COMPLETED","2019-06-14",{"date":97,"type":87},"2019-06-25",{"date":99,"type":87},"2012-12-13",{"date":101,"type":87},"2016-11-21",{"name":5,"class":6}]