A Phase 4 interventional study of Fosaprepitant Dimeglumine and 5-HT3 antagonist in Chemotherapy-induced Nausea and Vomiting, sponsored by Merck Sharp & Dohme LLC. Completed at 26 sites in 9 countries. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2025-01-16.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 4, Interventional, and Prevention
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant dimeglumine (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy. Each participant was enrolled in Cycle 1 (on which the primary study objectives were based), consisting of the 3-day treatment cycle and 14 days of follow-up for a total of 17 days.
Upon completion of Cycle 1, participants were given the option to exit the study and be considered completed, or to continue on study therapy for up to 2 more (optional) 17-day cycles of chemotherapy where fosaprepitant was administered and additional safety data collected.
1,123 studies on the registry are indexed under Vomiting; 137 are open to participants now.
This study's enrollment of 103 is close to the median of 105 across 954 interventional studies indexed under Vomiting.
Browse Vomiting studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,159 studies on the registry; 133 are open to participants now.
Of its 497 completed or terminated interventional studies of FDA-regulated products, 369 (74%) have results posted.
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Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT3\]) receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
Drug: Fosaprepitant Dimeglumine · Drug: 5-HT3 antagonist · Drug: Dexamethasone
Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).
Also known as: EMEND for injection®, MK-0517
All participants received an oral 5-hydroxytryptamine (serotonin; \[5-HT\]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care.
Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who experience one or more AE(s) is presented.
Time frame: Up to 17 days
Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE)
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who discontinue study treatment due to an AE is presented.
Time frame: Up to 3 days
Eligible participants were recruited at 25 study sites in 9 countries.
| Milestone | Fosaprepitant Treatment |
|---|---|
| Started | 103 |
| Treated (≥1 dose) | 100 |
| Completed | 98 |
| Not completed | 5 |
| Withdrew: Physician decision | 1 |
| Withdrew: Consent withdrawn by parent/guardian | 1 |
| Withdrew: Allocated but not treated | 3 |
| Milestone | Fosaprepitant Treatment |
|---|---|
| Started | 69 |
| Completed | 48 |
| Not completed | 21 |
| Withdrew: Physician decision | 2 |
| Withdrew: Consent withdrawn by parent/guardian | 2 |
| Withdrew: Various reasons | 17 |
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who experience one or more AE(s) is presented.
| Percentage of Participants | Fosaprepitant Treatment |
|---|---|
| Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs) | 80.0 |
An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who discontinue study treatment due to an AE is presented.
| Percentage of Participants | Fosaprepitant Treatment |
|---|---|
| Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE) | 2.0 |
Collected over Up to approximately 3.5 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fosaprepitant Cycle 1 | 0/103 (0%) | 30/100 (30%) | 64/100 (64%) |
| Fosaprepitant Cycles 2-3 | 0/69 (0%) | 27/69 (39.1%) | 27/69 (39.1%) |
| Event | Fosaprepitant Cycle 1 | Fosaprepitant Cycles 2-3 |
|---|---|---|
| Febrile neutropeniaBlood and lymphatic system disorders | 17/100 | 15/69 |
| AnaemiaBlood and lymphatic system disorders | 1/100 | 4/69 |
| ThrombocytopeniaBlood and lymphatic system disorders | 0/100 | 3/69 |
| StomatitisGastrointestinal disorders | 2/100 | 2/69 |
| LeukopeniaBlood and lymphatic system disorders | 0/100 | 2/69 |
| NeutropeniaBlood and lymphatic system disorders | 0/100 | 2/69 |
| BacteraemiaInfections and infestations | 0/100 | 2/69 |
| NauseaGastrointestinal disorders | 2/100 | 0/69 |
| VomitingGastrointestinal disorders | 1/100 | 1/69 |
| FatigueGeneral disorders | 1/100 | 1/69 |
| Event | Fosaprepitant Cycle 1 | Fosaprepitant Cycles 2-3 |
|---|---|---|
| AnaemiaBlood and lymphatic system disorders | 24/100 | 7/69 |
| NauseaGastrointestinal disorders | 24/100 | 8/69 |
| VomitingGastrointestinal disorders | 16/100 | 8/69 |
| NeutropeniaBlood and lymphatic system disorders | 15/100 | 4/69 |
| HaematotoxicityBlood and lymphatic system disorders | 9/100 | 10/69 |
| Neutrophil count decreasedInvestigations | 14/100 | 2/69 |
| ThrombocytopeniaBlood and lymphatic system disorders | 11/100 | 3/69 |
| Platelet count decreasedInvestigations | 9/100 | 4/69 |
| White blood cell count decreasedInvestigations | 7/100 | 1/69 |
| ConstipationGastrointestinal disorders | 6/100 | 3/69 |
| Age, Continuous(Years) | Fosaprepitant Treatment |
|---|---|
| Mean | 7.7 ± 5.0 |
| Sex: Female, Male(Participants) | Fosaprepitant Treatment |
|---|---|
| Female | 50 |
| Male | 53 |
| Ethnicity (NIH/OMB)(Participants) | Fosaprepitant Treatment |
|---|---|
| Hispanic or Latino | 22 |
| Not Hispanic or Latino | 77 |
| Unknown or Not Reported | 4 |
| Race (NIH/OMB)(Participants) | Fosaprepitant Treatment |
|---|---|
| American Indian or Alaska Native | 14 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 81 |
| More than one race | 6 |
| Unknown or Not Reported | 0 |
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Ran from Sep 2019 to primary completion in Feb 2021, 17 months.
Results were first posted in Sep 2021, 7 months after primary completion.
Of 74 phase 4 interventional studies under Vomiting, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 25. This study's 17 months is above that.
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Studies of the drug tested here: Fosaprepitant