Study on IV NEPA (Fosnetupitant/Palonosetron) for Preventing Chemotherapy-Induced Nausea and Vomiting in Pediatric Cancer Patients

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What is this study about?

This clinical trial is focused on studying the prevention of chemotherapy-induced nausea and vomiting in children with cancer who are undergoing chemotherapy that is likely to cause severe nausea and vomiting. The study will use a treatment called IV NEPA, which is a combination of two substances: fosnetupitant and palonosetron. These substances are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will compare the effectiveness of IV NEPA with other treatments, including fosaprepitant and ondansetron, which are also used to prevent nausea and vomiting caused by chemotherapy.

The purpose of the study is to see how well IV NEPA works in preventing nausea and vomiting in children receiving chemotherapy. The study will be conducted in two parts. In the first part, children will receive a single dose of IV NEPA and will be compared to those receiving fosaprepitant and ondansetron. In the second part, children will receive repeated doses of IV NEPA and will be compared to those receiving a combination of aprepitant and ondansetron. The study will monitor the safety and effectiveness of these treatments over time.

Participants in the study will receive their assigned treatment and will be closely monitored by healthcare professionals. The study aims to provide valuable information on the best ways to prevent nausea and vomiting in children undergoing chemotherapy, helping to improve their comfort and quality of life during treatment. The study is expected to continue until the end of 2027.

1 initial assessment

Upon joining the study, an initial assessment is conducted to ensure eligibility. This includes a review of medical history, current health status, and any previous treatments.

A physical examination and laboratory tests, such as blood and urine tests, are performed to confirm that participation in the study is safe.

2 part I: single cycle treatment

In Part I, patients are divided into two groups. Cohort 1 receives a single dose of IV NEPA (fosnetupitant/palonosetron) to prevent nausea and vomiting caused by chemotherapy.

The dosage for Cohort 1 is based on weight: 3.13 mg/kg for patients aged 3 months to under 18 years, with a maximum of 235 mg for those weighing 75 kg or more. For patients under 3 months, the dosage is 1.88 mg/kg.

In Cohort 2, the safety and tolerability of repeated IV NEPA administration are assessed. The treatment is given on Days 1, 3, and possibly Day 5, depending on the chemotherapy schedule.

3 part II: repeated cycles treatment

In Part II, patients receive repeated cycles of IV NEPA or a combination of IV fosaprepitant and IV ondansetron to prevent nausea and vomiting during multi-day chemotherapy.

The goal is to demonstrate that IV NEPA is not less effective than the alternative treatment in preventing delayed nausea and vomiting, which occurs more than 24 hours after chemotherapy starts.

4 monitoring and follow-up

Throughout the study, regular monitoring is conducted to ensure safety and effectiveness. This includes physical examinations, vital signs checks, and laboratory tests.

Patients are observed for any side effects or adverse events, and their response to the treatment is evaluated.

Follow-up visits are scheduled to assess long-term outcomes and gather additional data on the treatment’s effectiveness.

Who Can Join the Study?

For Part I, Cohort 1: The patient must be younger than 6 months and weigh at least 4 kg, or be 6 months or older and weigh at least 6 kg.
For Part I, Cohort 2: The patient must weigh at least 4 kg.
For Part II: The patient must weigh at least 6 kg.
The patient can have some abnormal lab test results if the doctor believes it won’t affect their safety.
For Part I, Cohort 1: The patient must be scheduled to receive at least one cycle of single-day HEC (highly emetogenic chemotherapy, which means chemotherapy that is likely to cause nausea and vomiting).
For Part I, Cohort 2: The patient must be scheduled to receive at least one cycle of multi-day HEC.
For Part II: The patient must be scheduled to receive repeated cycles of multi-day HEC.
The patient must have a predicted life expectancy of at least 3 months, according to the doctor’s opinion.
For patients aged 10 years or older: The patient must have an ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 2 or less. This is a scale used to assess how a patient’s disease is progressing, including their level of functioning and ability to care for themselves.
If the patient has known liver problems, they can participate if certain liver tests are within safe limits and the doctor believes it won’t affect their safety.
If the patient has known kidney problems, they can participate if their eGFR (estimated glomerular filtration rate, a test to check how well the kidneys are working) is at least 70 mL/min/1.73m² (or at least 50 mL/min/1.73m² for children under 3 months old) and the doctor believes it won’t affect their safety.
If the patient has a history or risk of heart problems, they can participate if the doctor believes it won’t affect their safety.

Who Cannot Join the Study?

Patients who are not within the age range of 3 months to less than 18 years cannot participate.
Patients who are not receiving chemotherapy that causes nausea and vomiting cannot participate.
Patients who have any medical condition that the study doctors think would make it unsafe for them to participate cannot join the study.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial within the last 30 days cannot join this study.
Patients who have a known allergy to any of the study medications cannot participate.
Patients who are unable to follow the study procedures or instructions cannot participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi	Lodz	Poland
Uniwersytecki Szpital Dzieciecy W Lublinie	Lublin	Poland
Pomeranian Medical University	Szczecin	Poland

Other Sites

Site Name	City	Country
Nosokomeio Paidon I Agia Sofia	Athens	Greece
Institutul Oncologic Prof. Dr. Alexandru Trestioreanu Bucuresti	Bucharest	Romania
Wojewódzki Szpital Dziecięcy im. J. Brudzińskiego w Bydgoszczy	Bydgoszcz	Poland
Instytut Matki I Dziecka	Warsaw	Poland
University General Hospital Of Thessaloniki Ahepa	Thessaloniki	Greece
Spitalul Clinic De Urgenta Pentru Copii Louis Turcanu Timisoara	Timisoara	Romania
Instytut Pomnik Centrum Zdrowia Dziecka	Warsaw	Poland
Uniwersytecki Dzieciecy Szpital Kliniczny Im. L. Zamenhofa W Bialymstoku samodzielny publiczny zakład opieki zdrowotnej	Bialystok	Poland
Wojewodzki Szpital Specjalistyczny W Olsztynie	Olsztyn	Poland
Fundeni Clinical Institute	Bucharest	Romania
Scxhidd Kmcqcrbto Iug Krraqt Jqmtjpbtu Uoipdosyxvcv Mwgzyriyah Ihc Kyvkuj Mznjpoyzvgpbzxf W Ppmkdtxi	Poznan	Poland

Trial status

Country	Status	Recruitment Start
Greece	Recruiting	05.05.2025
Poland	Recruiting	05.05.2025
Romania	Recruiting	05.05.2025

Trial locations

Investigated drugs:

IV NEPA is a combination of two medications, fosnetupitant and palonosetron, given through an intravenous (IV) infusion. It is used to prevent nausea and vomiting caused by chemotherapy in children with cancer. Fosnetupitant helps block the signals in the brain that trigger nausea and vomiting, while palonosetron works by blocking the action of serotonin, a natural substance that can cause nausea and vomiting. Together, they help reduce the chances of feeling sick during and after chemotherapy.

Fosaprepitant is a medication given through an IV infusion to help prevent nausea and vomiting caused by chemotherapy. It works by blocking certain signals in the brain that trigger nausea and vomiting, helping patients feel better during and after their cancer treatment.

Ondansetron is a medication that is also given through an IV infusion to prevent nausea and vomiting caused by chemotherapy. It works by blocking the action of serotonin, a natural substance in the body that can cause nausea and vomiting. This helps patients undergoing chemotherapy feel less sick.

Aprepitant is a medication used to prevent nausea and vomiting caused by chemotherapy. It is usually given in combination with other medications like ondansetron. Aprepitant works by blocking certain signals in the brain that can trigger nausea and vomiting, helping patients feel more comfortable during their cancer treatment.

Investigated diseases:

Prophylaxis of nausea and vomiting

Chemotherapy-induced nausea and vomiting – This condition occurs as a side effect of chemotherapy treatment for cancer. It involves the sensation of nausea and the act of vomiting, which can happen shortly after chemotherapy or be delayed by several hours or days. The severity and timing of these symptoms can vary depending on the type of chemotherapy drugs used and individual patient factors. Nausea is the feeling of needing to vomit, while vomiting is the act of expelling stomach contents through the mouth. These symptoms can significantly affect a patient’s quality of life and may lead to dehydration and malnutrition if not managed properly. The condition is a common challenge for patients undergoing cancer treatment.

Trial ID:

2024-514321-39-00

Protocol code:

NEPA-22-01

Trial Phase:

Therapeutic use (Phase IV)

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Study on IV NEPA (Fosnetupitant/Palonosetron) for Preventing Chemotherapy-Induced Nausea and Vomiting in Pediatric Cancer Patients

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