Recruiting

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

Fast replyRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

12 criteria

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 trial?

7 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Instytut Pomnik Centrum Zdrowia Dziecka
Warsaw, Poland
Responsive
Nosokomeio Paidon I Agia Sofia
Athens, Greece
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

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.

What is already known about the treatment

IV NEPA (fosnetupitant/palonosetron) – This medication is given through an intravenous (IV) infusion, meaning it is administered directly into a vein. It is currently being studied in clinical trials for its effectiveness and safety in preventing nausea and vomiting caused by chemotherapy in children with cancer. The main use of IV NEPA is to help prevent these uncomfortable side effects during and after chemotherapy. It works by blocking certain signals in the brain that trigger nausea and vomiting. IV NEPA is classified as an antiemetic, which is a type of drug used to prevent nausea and vomiting.

Investigated diseases

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.