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Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)

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ClinicalTrials.gov Identifier: NCT04054193
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to evaluate the safety and tolerability of a 3-day intravenous (IV) fosaprepitant (MK-0517) regimen for the prevention of CINV in pediatric participants scheduled to receive emetogenic chemotherapy.

Condition or disease Intervention/treatment Phase
Chemotherapy-induced Nausea and Vomiting Drug: Fosaprepitant Drug: 5-HT3 antagonist Drug: Dexamethasone Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : September 9, 2019
Estimated Primary Completion Date : April 13, 2021
Estimated Study Completion Date : April 13, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Fosaprepitant Regimen
Participants will receive 115 mg or an age-adjusted dose of intravenous (IV) fosaprepitant in combination with a 5-hydroxytryptamine 3 (5-HT3) antagonist on Day 1 of emetogenic chemotherapy. Following Day 1, participants will receive single-daily 80 mg or age-adjusted doses of IV fosaprepitant on Days 2 and 3 with or without a 5-HT3 antagonist. Participants may also receive dexamethasone at investigator's discretion based on the local standard of care.
Drug: Fosaprepitant
Intravenous (IV) infusion
Other Names:
  • EMEND for injection®
  • MK-0517

Drug: 5-HT3 antagonist
Administered according to the product label or local standard of care

Drug: Dexamethasone
Administered according to the product label or local standard of care.




Primary Outcome Measures :
  1. Percentage of Participants Who Experienced One or More Adverse Events (AEs) [ Time Frame: Up to approximately 3.5 months ]
    An adverse event (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 who experience one or more AE(s) will be presented.

  2. Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) [ Time Frame: Up to approximately 3.5 months ]
    An adverse event (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 who discontinue study treatment due to an AE will be presented.



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Ages Eligible for Study:   6 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is receiving a moderately or highly emetogenic chemotherapy agent/regimen or a chemotherapy agent/regimen not previously tolerated due to vomiting
  • Has a Lansky Play Performance score ≥60 (participants ≤16 years of age) or a Karnofsky score ≥60 (participants >16 years of age)
  • Has a pre-existing functional central venous catheter available for study treatment administration
  • Is fosaprepitant naïve
  • Has a predicted life expectancy ≥3 months
  • 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 not be sexually active or use a highly effective contraceptive method for at least 28 days prior to receiving study treatment, during the treatment period, and for at least 30 days (or local standard of care if longer) after the last dose of study treatment (including the optional cycles)
  • Has 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 WOCBP
  • Weighs at least 6 kilograms (kg)

Exclusion Criteria:

  • 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
  • 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
  • Is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry
  • Is pregnant or breast feeding
  • Is allergic to fosaprepitant, aprepitant, or prescribed 5-HT3 antagonist
  • 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 treatment or concomitant therapy to the participant
  • Is a WOCBP who has a positive pregnancy test at screening (Cycle 1) or on Day 1 of optional Cycles 2 or 3
  • Has been started on systemic corticosteroid therapy within 72 hours prior to study treatment administration or is expected to receive a corticosteroid as part of the chemotherapy regimen. Exceptions apply
  • Is taking excluded medications
  • Has ever participated in a previous study of aprepitant or fosaprepitant or has taken a non-approved (investigational) drug within the last 4 weeks
  • Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04054193


Contacts
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Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
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United States, California
Southern California Permanente Medical Group ( Site 1104) Recruiting
Los Angeles, California, United States, 90027
Contact: Study Coordinator    323-783-5307      
United States, Tennessee
St. Jude Children's Research Hospital ( Site 1111) Recruiting
Memphis, Tennessee, United States, 38105
Contact: Study Coordinator    901-595-8149      
Lithuania
LSMUL Kauno Klinikos ( Site 0402) Recruiting
Kaunas, Lithuania, 50161
Contact: Study Coordinator    +37037326033      
Peru
Clinica Delgado ( Site 1503) Recruiting
Lima, Peru, 15074
Contact: Study Coordinator    +51962709308      
Russian Federation
Chelyabinsk Regional Children Clinical Hospital ( Site 0705) Recruiting
Chelyabinsk, Russian Federation, 454076
Contact: Study Coordinator    +79517846624      
N.N. Blokhin National Medical Oncology Research Centre ( Site 0701) Recruiting
Moscow, Russian Federation, 115478
Contact: Study Coordinator    +74993242424      
Clinical Research Center of specialized types medical care-Oncology ( Site 0706) Recruiting
Saint Petersburg, Russian Federation, 197758
Contact: Study Coordinator    +79219316905      
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT04054193     History of Changes
Other Study ID Numbers: 0517-045
2018-004844-43 ( EudraCT Number )
MK-0517-045 ( Other Identifier: Merck Protocol Number )
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Fosaprepitant
Aprepitant
BB 1101
Serotonin 5-HT3 Receptor Antagonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Serotonin Antagonists
Serotonin Agents