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Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients

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ClinicalTrials.gov Identifier: NCT04508400
Recruitment Status : Not yet recruiting
First Posted : August 11, 2020
Last Update Posted : September 2, 2021
Sponsor:
Information provided by (Responsible Party):
Yizhuo Zhang, Sun Yat-sen University

Study Description
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Brief Summary:
The purpose is to evaluate the effectiveness and safety of fosaprepitant plus ondansetron with dexamethasone or placebo plus ondansetron with dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HE multi-day chemotherapy in children with solid tumors.

Condition or disease Intervention/treatment Phase
Pediatric Cancer Drug: Fosaprepitant Drug: placebo ondansetron with dexamethasone Phase 2

Detailed Description:

Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo to fosaprepitant plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner.

Experimental:

Participants received a single dose of fosaprepitant (age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy.

Placebo Comparator:

Participants received a single dose of matched placebo for fosaprepitant administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy, Safety and Feasibility of Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients With Solid Tumors Receiving Moderately and Highly Emetogenic Chemotherapy
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : October 10, 2022
Estimated Study Completion Date : May 10, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: a single dose of fosaprepitant
Participants received a single dose of fosaprepitant (age-based adjustment) administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy.
 Drug: Fosaprepitant
Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner.
Other Name: ondansetron, dexamethasone
Placebo Comparator: a single dose of matched placebo
Participants received a single dose of matched placebo for fosaprepitant administered intravenously (IV) on Day 1 prior to chemotherapy plus ondansetron (weight based) IV with dexamethasone (weight based) iv/po prior to chemotherapy and up to 72 hours after chemotherapy.
 Drug: placebo ondansetron with dexamethasone
placebo plus ondansetron with dexamethasone
Other Name: ondansetron, dexamethasone


Outcome Measures
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Primary Outcome Measures :
  1. CR rate [ Time Frame: between 0 and 120 hours after the start of chemotherapy ]
    Percentage of participants who experienced a complete response (CR; no vomiting/rescue medication) rate in overall phases.


Secondary Outcome Measures :
  1. CR rate in acute phase [ Time Frame: 0 to 24 Hours Post Initiation of Chemotherapy ]
    Complete response rate in acute phase

  2. CR rate in delayed phase [ Time Frame: 25 to 120 Hours Post Initiation of Chemotherapy ]
    Complete response rate in delayed phase


Eligibility Criteria
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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:

  1. Is 6 months to 17 years of age at time of randomization;
  2. Participants with solid tumors receiving multi -day chemotherapy associated with moderate or high risk of emetogenicity;
  3. Has a preexisting functional central venous catheter available for study drug administration;
  4. PS score ≤ 2 points;
  5. Has a predicted life expectancy ≥3 months or weight greater than 6Kg;
  6. Patient's parent or guardian signs informed consent.

Exclusion Criteria:

  1. Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1;
  2. Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study);
  3. Will be receiving stem cell rescue therapy in conjunction with study-related course of emetogenic chemotherapy or during the 14 days following administration of fosaprepitant/placebo for fosaprepitant;
  4. Has received or will receive total body irradiation of radiation therapy to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting period (120 hours following initiation of chemotherapy);
  5. Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within 120 hours following initiation of chemotherapy except for single doses of midazolam, temazepam or triazolam;
  6. Has started on systemic corticosteroid therapy within 72 hours prior to study drug administration or is expected to receive a corticosteroid as part of the chemotherapy regimen
  7. Is currently taking, or has taken within 48 hours of Treatment Day 1 the following drugs with antiemetic properties: 5-hydroxytryptamine 3 (5-HT3) antagonists (e.g., ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorpenzine), scopolamine (this is not an exhaustive list);
  8. Is currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence;
  9. Is mentally incapacitated or has a significant emotional or psychiatric disorder;
  10. Is allergic to fosaprepitant, aprepitant (MK-0869), ondansetron, or any other 5-HT3 antagonist;
  11. Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation;
  12. Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy;
  13. Has ever participated in a previous study of aprepitant or fosaprepitant or has taken an investigational drug with the last 4 weeks;
  14. Abnormal liver function (alanine aminotransferase or aspartate aminotransferase ≥ 2 times higher than the upper bound of the normal value) or abnormal renal function (serum creatinine ≥ 2.5 times higher than the upper bound of the normal value);
  15. Has participated in a preliminary study of Aprepitant or Fosapretan, or took the study drug in the past 4 weeks;
  16. Other situations that the researcher thinks cannot be included.
Contacts and Locations
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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): NCT04508400


Contacts
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Contact: Yizhuo Zhang, PhD 020-87342459 zhangyzh@sysucc.org.cn

Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Yizhuo Zhang Sun Yat-sen University
More Information
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Responsible Party: Yizhuo Zhang, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04508400    
Other Study ID Numbers: SunYat-senU-fosaprepitant
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vomiting
Signs and Symptoms, Digestive
Dexamethasone
Dexamethasone acetate
Ondansetron
Fosaprepitant
Aprepitant
BB 1101
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
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants