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Prevention study for Nausea and Vomiting Chemotherapy-Induced
Official title Study With IV NEPA (Fosnetupitant/Palonosetron) for the Prevention of Chemotherapy-induced Nausea and Vomiting in Paediatric Cancer Patients Undergoing Highly Emetogenic Chemotherapy (HEC)
ClinicalTrials.gov ID: NCT06904235
What this study is testing
What is IV NEPA (fosnetupitant/palonosetron)?
IV NEPA (fosnetupitant/palonosetron) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nausea and vomiting chemotherapy-induced.
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
- Chemotherapy often causes nausea and vomiting (CINV), and this is a major problem for the children being treated for cancer. To prevent this, a combination of two substances in fixed proportion (IV NEPA) was developed.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18
You may be able to join if
- The following must be checked prior to study inclusion:
- Signed written Informed Consent Form (ICF) by parent(s)/legal guardian of the paediatric patient in compliance with the local laws and regulations...
- Male or female in- or out-patient from 0 months (newborns) to \<18 years on the date of enrolment (Day 1).
- Cohort 1: Patient \< 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg. Cohort 2: Patient weighing at least 4 kg.
- Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.
You likely can't join if
- The patient and/or parent(s)/legal guardian are expected by the Investigator to be non compliant with the study procedures.
- Patient has received or is scheduled to receive total body irradiation; total nodal irradiation; upper abdomen radiotherapy; half or upper body...
- Known history of allergy to any component of the study treatments or other contraindications to any NK1-RAs or 5-HT3-RAs.
- Active infection.
- Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering the investigational product to the...
- Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).
See the full eligibility criteria
Who can join
- The following must be checked prior to study inclusion:
- Signed written Informed Consent Form (ICF) by parent(s)/legal guardian of the paediatric patient in compliance with the local laws and regulations. In addition, the signed children's Assent Form according to local...
- Male or female in- or out-patient from 0 months (newborns) to \<18 years on the date of enrolment (Day 1).
- Cohort 1: Patient \< 6 months weighing at least 4 kg or patient ≥ 6 months weighing at least 6 kg. Cohort 2: Patient weighing at least 4 kg.
- Patient with a predicted life expectancy ≥3 months according to Investigator's opinion.
- Patient naïve or non-naïve to chemotherapy, with histologically and/or cytologically (or imaging in the case of brain tumours and nephroblastomas) confirmed malignant disease.
- Cohort 1: Patient scheduled and eligible to receive at least 1 cycle of single-day HEC. Cohort 2: Patient scheduled and eligible to receive at least 1 cycle of multi-day HEC. (For the level of emetogenicity of the...
- For patients aged ≥10 years: Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤2.
- For patient with known hepatic impairment: the patient may be enrolled provided the serum ALT and AST are ≤2.5 ULN, the total bilirubin is ≤1.5 ULN, and in the Investigator's opinion the impairment is not expected to...
- For patient with known renal impairment: the patient may be enrolled provided the estimated glomerular filtration rate (eGFR) is ≥70 mL/min/1.73m2 (≥50 mL/min/1.73m2 for children \<3 months old) (the eGFR should be...
- For patient with known history or predisposition to cardiac abnormalities: as per the Investigator's opinion, the history/predisposition should not jeopardize patient's safety during the study.
- Patient with non-clinically significant abnormal laboratory values or with clinically relevant abnormal laboratory values may be enrolled if in the Investigator's opinion the patient's safety is not expected to be...
- Female patient shall: a) not have attained menarche yet or b) have attained menarche and have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at Day 1.
- Male or female fertile patient using reliable contraceptive measures. Such measures, for patient and sexual partner, include: implants, injectables, combined oral contraceptives, intrauterine devices...
What rules you out
- The patient and/or parent(s)/legal guardian are expected by the Investigator to be non compliant with the study procedures.
- Patient has received or is scheduled to receive total body irradiation; total nodal irradiation; upper abdomen radiotherapy; half or upper body irradiation; or radiotherapy of the cranium, craniospinal regions, head and...
- Known history of allergy to any component of the study treatments or other contraindications to any NK1-RAs or 5-HT3-RAs.
- Active infection.
- Any illness or condition that, in the opinion of the Investigator, may pose unwarranted risks in administering the investigational product to the patient.
- Uncontrolled medical condition (e.g., uncontrolled insulin-dependent diabetes mellitus).
- Patient experiencing ongoing vomiting from any organic aetiology (including patients with history of gastric outlet obstruction or intestinal obstruction due to adhesions or volvulus), or patient with hydrocephalus.
- Patient who experienced any vomiting, retching, or nausea within 24 h prior to the administration of the study treatment on Day 1 (Note: functional vomiting for infants, which is normally seen during the first 3 months...
- Patient who received any drug with potential antiemetic effect within 24 h prior to administration of study treatment on Day 1, including but not limited to the following:
- NK1-RAs (e.g., (fos)aprepitant or any other drug of this class)
- 5-HT3-RAs (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron)
- Benzamides (e.g., metoclopramide, alizapride)
- Phenothiazines (e.g., prochlorperazine, promethazine, perphenazine, fluphenazine, chlorpromazine, thiethylperazine)
- Benzodiazepines initiated 48 h prior to study treatment administration on Day 1 or expected to be administered within the how well it works assessment period, except for single doses of midazolam, temazepam, or triazolam
- Butyrophenones (e.g., droperidol, haloperidol)
- Anticholinergics (e.g., scopolamine, except the inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide)
- Antihistamines (e.g., diphenhydramine, cyclizine, hydroxyzine, chlorphenhyramine, dimenhydrinate, meclizine)
- Domperidone
- Mirtazapine
- Olanzapine
- Prescribed cannabinoids (e.g., tetrahydrocannabinol, nabilone)
- Over-the-counter (OTC) antiemetics, OTC cold medications, or OTC allergy medications
- Herbal preparations containing ephedra or ginger
- Patient who received palonosetron within 1 week prior to administration of study treatment on Day 1.
- Patient receiving systemic corticosteroid therapy above 0.14mg/kg or \>10 mg of prednisone daily or equivalent. Exception: Dexamethasone for the prevention of CINV is permitted in association with the study treatment...
- Patient aged \<6 years who received any investigational drug (defined as a medication with no marketing authorization granted for any age or indication) within 90 days prior to Day 1, or patient aged ≥6 years who...
- Intake of alcohol, food, or beverages (e.g., grapefruit, cranberry, pomegranate, and aloe vera juices; German chamomile) known to interfere with CYP3A4 or CYP2D6 metabolic enzymes within 1 week prior to Day 1 and during...
- Use of any drugs or substances known to be strong inhibitors of CYP3A4 or CYP2D6 enzymes within 1 week prior to Day 1 or planned to be used during the overall study period.
- Use of any drugs or substances known to be CYP3A4 substrates with narrow therapeutic range within 1 week prior to Day 1 or planned to be used during the overall study period.
- Use of any drugs or substances known to be strong inducers of CYP3A4 or CYP2D6 enzymes within 4 weeks prior to Day 1 or planned to be used during the overall study period.
- Lactating female patient.
- Enrolment in a previous study on netupitant (either administered alone or in combination with palonosetron).
- Marked baseline prolongation of QTc interval (QTcF\>460 millisecond [msec]). At the discretion of the investigator, criterion may be based on automatic interpretation of results.
The study team makes the final eligibility decision.
Where it's taking place
- Athens, Greece
- Thessaloniki, Greece
- Bialystok, Poland
- Bydgoszcz, Poland
- Lodz, Poland
- Lublin, Poland
- Olsztyn, Poland
- Poznan, Poland
- Szczecin, Poland
- Warsaw, Poland
- Bucharest, Romania
- Timișoara, Romania
- Istanbul, Faith, Turkey (Türkiye)
- Ankara, Mamak, Turkey (Türkiye)
- Kayseri, Melikgazi, Turkey (Türkiye)
- Ankara, Turkey (Türkiye)
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, 0 months to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Athens, Greece; Thessaloniki, Greece; Bialystok, Poland; Bydgoszcz, Poland; Lodz, Poland; Lublin, Poland and 10 more location(s). 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.