Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
Primary Purpose
Pediatric Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Fosaprepitant
placebo ondansetron with dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Cancer
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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;
- Other situations that the researcher thinks cannot be included.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
a single dose of fosaprepitant
a single dose of matched placebo
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
CR rate
Percentage of participants who experienced a complete response (CR; no vomiting/rescue medication) rate in overall phases.
Secondary Outcome Measures
CR rate in acute phase
Complete response rate in acute phase
CR rate in delayed phase
Complete response rate in delayed phase
Full Information
NCT ID
NCT04508400
First Posted
August 9, 2020
Last Updated
September 1, 2021
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT04508400
Brief Title
Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2021 (Anticipated)
Primary Completion Date
October 10, 2022 (Anticipated)
Study Completion Date
May 10, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
a single dose of fosaprepitant
Arm Type
Experimental
Arm Description
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.
Arm Title
a single dose of matched placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fosaprepitant
Other Intervention Name(s)
ondansetron, dexamethasone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
placebo ondansetron with dexamethasone
Other Intervention Name(s)
ondansetron, dexamethasone
Intervention Description
placebo plus ondansetron with dexamethasone
Primary Outcome Measure Information:
Title
CR rate
Description
Percentage of participants who experienced a complete response (CR; no vomiting/rescue medication) rate in overall phases.
Time Frame
between 0 and 120 hours after the start of chemotherapy
Secondary Outcome Measure Information:
Title
CR rate in acute phase
Description
Complete response rate in acute phase
Time Frame
0 to 24 Hours Post Initiation of Chemotherapy
Title
CR rate in delayed phase
Description
Complete response rate in delayed phase
Time Frame
25 to 120 Hours Post Initiation of Chemotherapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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;
Other situations that the researcher thinks cannot be included.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yizhuo Zhang, PhD
Phone
020-87342459
Email
zhangyzh@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yizhuo Zhang
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients
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