NL-OMON48224已完成4 期
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 - MK0517-045
Merck Sharp & Dohme (MSD)0 个研究点目标入组 6 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- 年龄范围
- 2 至 17（—）
入选标准
- •Inclusion Criteria for Cycle 1
- •1. Be receiving a moderately or highly emetogenic chemotherapy agent/regimen or
- •a chemotherapy agent/regimen not previously tolerated due to vomiting.
- •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
- •of the protocol.
- •3. Have a preexisting functional central venous catheter available for study
- •intervention administration.
- •4. Be fosaprepitant naïve.
- •Demographics
- •5. Have a predicted life expectancy *3 months.
- •6. Be male or female.
- •A female participant is eligible to participate if she is not pregnant or
- •breastfeeding, and at least one of the following conditions applies:
- •* Is not a woman of childbearing potential (WOCBP)
- •* Is a WOCBP and agrees to the following for at least 28 days prior to
- •receiving study intervention, during the intervention period, and for at least
- •30 days (or local standard of care if longer) after the last dose of study
- •intervention (including the optional cycles):
- •* Not be sexually active which includes being abstinent from heterosexual
- •intercourse as their preferred and usual lifestyle (abstinent on a long term
- •and persistent basis) as described in Appendix 5.
- •* If sexually active, or if initiation of sexual activity occurs during the
- •study, use a contraceptive method that is highly effective (with a failure rate
- •of <1% per year) as described in Appendix 5. The investigator should evaluate
- •the potential for contraceptive method failure (ie, noncompliance, recently
- •initiated) in relationship to the first dose of study intervention.
- •7. Be from 6 months to 17 years of age (inclusive) at the time of allocation.
- •8. Weigh at least 6 kg.
- •Informed Consent/Assent
- •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.
- •Inclusion Criteria for Optional Cycles 2 and 3
- •To be eligible for participation in an optional cycle, the participant must
- •meet inclusion criteria 1, 3, and 6 above in addition to the 2 criteria below.
- •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.
排除标准
- •Exclusion Criteria for Cycle 1 Only
- •Medical Conditions
- •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
- •Exclusion Criteria for Cycle 1 and Optional Cycles 2 and 3
- •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.
- •Prior/Concomitant Therapy
- •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.
- •Exceptions:
- •* Participant who is receiving chronic (>72 hours), daily steroid therapy can
- •be enrolled provided the steroid dose is not >0.14 mg/kg (up to 10 mg) of
- •prednisone daily or equivalent.
- •* For supportive care, participant is permitted to receive a single dose of
- •corticosteroid within 3 days prior (but not on the days of study intervention
- •administration) provided it is less than the equivalent of 20 mg of prednisone.
- •10. Has received any medication within the timeframes listed in Table 1 of the
- •protocol or needs to receive any medication listed in Table 1 of the protocol
- •during the time period specified relative to the last dose of fosaprepitant in
- •a given cycle.
- •Prior/Concurrent Clinical Study Experience
- •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.
- •Diagnostic Assessments
- •12. Has a known history of QT prolongation or is taking any medication that is
- •known to lead to QT prolongation.
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