Three-day Fosaprepitant Regimen CINV Safety Study in Pediatric Participants
- Conditions
- Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV)MedDRA version: 20.1Level: PTClassification code 10054133Term: Prophylaxis of nausea and vomitingSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Symptoms and general pathology [C23]
- Registration Number
- EUCTR2018-004844-43-NL
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
To be eligible for inclusion in this study, the participant must:
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).
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.
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)
- 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). The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
-A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) prior to the start of fosaprepitant administration in a given cycle. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
-Additional requirements for pregnancy testing during and after study intervention
-The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- A WOCBP must agree to add a barrier form of contraception (ie, male condom) to a hormonal contraception during the intervention period and for 30 days following the last dose of study intervention (or local standard of care if longer).
- The investigator is responsible for assuring that for a given participant, appropriate contraception requirements are followed if more stringent contraception is required for one of the non-study related medications that are being administered to treat the participant’s cancer (ie, chemotherapeutic agents).
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.
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
The participant must be excluded from the study if the participant:
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.
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 prohibited by protocol within the timeframes or needs to receive any prohibited medication during the time period specified relative to the last dose of fosaprepitant in a given cycle.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety and tolerability of the 3-day fosaprepitant regimen.;Secondary Objective: Not applicable;Primary end point(s): 1. Percentage of Participants Who Experienced One or More Adverse Events (AEs)<br>2. Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE);Timepoint(s) of evaluation of this end point: 1. Up to approximately 3.5 months<br>2. Up to approximately 3.5 months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable