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

Phase 4

Completed

Conditions: Symptomen en algemene pathologie
Chemotherapy-Induced Nausea and Vomiting

Registration Number: NL-OMON48224

Lead Sponsor: Merck Sharp & Dohme (MSD)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 6

Inclusion Criteria

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)
OR
* 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.
OR
* 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.

Exclusion Criteria

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.