NCT04508400

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 9, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
Last Updated

January 9, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

August 9, 2020

Last Update Submit

January 7, 2024

Conditions

Pediatric Cancer

Outcome Measures

Primary Outcomes (1)

  • CR rate

    Percentage of participants who experienced a complete response (CR; no vomiting/rescue medication) rate in overall phases.

    between 0 and 120 hours after the start of chemotherapy

Secondary Outcomes (2)

  • CR rate in acute phase

    0 to 24 Hours Post Initiation of Chemotherapy

  • CR rate in delayed phase

    25 to 120 Hours Post Initiation of Chemotherapy

Study Arms (2)

a single dose of fosaprepitant

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.

Drug: Fosaprepitant,ondansetron, dexamethasone

a single dose of matched placebo

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.

Drug: placebo ondansetron with dexamethasone

Interventions

Fosaprepitant,ondansetron, dexamethasoneDRUG

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.

Also known as: ondansetron, dexamethasone
a single dose of fosaprepitant
placebo ondansetron with dexamethasoneDRUG

placebo plus ondansetron with dexamethasone

Also known as: ondansetron, dexamethasone
a single dose of matched placebo

Eligibility Criteria

Age6 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Has vomited in the 24 hours prior to chemotherapy initiation on Treatment Day 1;
  • Has a symptomatic primary or metastatic central nervous system (CNS) malignancy with nausea and/or vomiting (asymptomatic participants may participate in study);
  • 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;
  • 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);
  • 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;
  • 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
  • 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);
  • Is currently a user of any recreational or illicit drugs (including marijuana) or has current evidence of drug or alcohol abuse or dependence;
  • Is mentally incapacitated or has a significant emotional or psychiatric disorder;
  • Is allergic to fosaprepitant, aprepitant (MK-0869), ondansetron, or any other 5-HT3 antagonist;
  • Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation;
  • Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy;
  • Has ever participated in a previous study of aprepitant or fosaprepitant or has taken an investigational drug with the last 4 weeks;
  • 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);
  • Has participated in a preliminary study of Aprepitant or Fosapretan, or took the study drug in the past 4 weeks;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

fosaprepitantOndansetronDexamethasone

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCarbazolesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds, 3-RingPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Yizhuo Zhang

    Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 9, 2020

First Posted

August 11, 2020

Study Start

August 1, 2022

Primary Completion

June 22, 2023

Study Completion

June 22, 2023

Last Updated

January 9, 2024

Record last verified: 2024-01

Locations

CN(1)