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Compares treatment options for Pediatric Solid Tumor, Unspecified, Protocol Specific
Official title Ondansetron (ODF) Versus Ondansetron Intravenously for the Prevention of Chemotherapy-induced Nausea and Vomiting Compare in Children
ClinicalTrials.gov ID: NCT06208917
What this study is testing
What is Ondansetron (Oral soluble film OR injections) ,Dexamethasone?
Ondansetron (Oral soluble film OR injections) ,Dexamethasone is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for pediatric solid tumor, unspecified, protocol specific.
Also referred to as Ondansetron，Dexamethasone.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose is to evaluate the efficacy of ondansetron oral soluble film plus dexamethasone in preventing chemotherapy-induced nausea and vomiting (CINV) with MEC/HEC chemotherapy in children with solid tumor.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 18
You may be able to join if
- Children aged 6 months to 18 years at the time of randomization;
- Diagnosed of solid tumor by cytological or histological examination;
- Going to initiate MEC/HEC chemotherapy;
- PS score ≤ 2 points;
- predicted life expectancy ≥3 months and weight greater than 6Kg;
You likely can't join 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...
- Will be receiving stem cell rescue therapy within 14 days following administration of ondansetron ;
- Has experienced High emetic chemotherapy within two weeks ;
- Has received or will receive total body irradiation to the abdomen or pelvis in the week prior to Treatment Day 1 and/or during the diary reporting...
- Has had benzodiazepine, opioid or opioid like therapy initiated within 48 hours prior to study drug administration, or is expected to receive within...
See the full eligibility criteria
- Children aged 6 months to 18 years at the time of randomization;
- Diagnosed of solid tumor by cytological or histological examination;
- Going to initiate MEC/HEC chemotherapy;
- PS score ≤ 2 points;
- predicted life expectancy ≥3 months and weight greater than 6Kg;
- Patient's parent or guardian signs informed consent
- 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 within 14 days following administration of ondansetron ;
- Has experienced High emetic chemotherapy within two weeks ;
- Has received or will receive total body irradiation 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...
- 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 ;
- Allergic to Ondansetron and dexamethasone ;
- Has an active infection (e.g., pneumonia), congestive heart failure, bradyarrhythmia, any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) except for malignancy ;
- Is mentally incapacitated or has a significant emotional or psychiatric disorder ;
- Has a known history of QT prolongation or is taking any medication that is known to lead to QT prolongation ;
- 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...
- 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)...
- Has ever participated in a previous study of ondansetron or has taken an investigational drug with the last 4 weeks ;
- other situations in which the researchers believe that they cannot be included in the group.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.