#1 Clinical Trials Search in Europe

204-NETU

Clinical trials are investigating 204-NETU in children and teenagers with cancer who receive highly emetogenic chemotherapy, which means chemotherapy that often causes nausea and vomiting. The studies look at safety, drug exposure, and how well it prevents chemotherapy-induced nausea and vomiting in different treatment schedules.

Table of contents

Clinical trial overview

The available trial on 204-NETU is an interventional study in pediatric cancer patients who receive highly emetogenic chemotherapy, or chemotherapy with a high chance of causing vomiting.[1]

The study is authorised and in Phase 4, which means it is being studied later in development and in a more practical treatment setting.[1]

The trial includes 120 participants.[1]

Study design and trial parts

The study has two main parts.[1]

Part I is open-label, which means the treatment is known during the study, and it focuses on pharmacokinetics, safety, and efficacy after a single cycle and after repeated cycles in children receiving single-day or multi-day highly emetogenic chemotherapy.[1]

In Part I, Cohort 1 measures pharmacokinetics, meaning how the body handles the drug, by looking at maximum concentration (Cmax) and area under the plasma concentration-time curve (AUC), which shows total drug exposure over time.[1]

In Part I, Cohort 2 focuses on safety and tolerability after repeated IV NEPA administration on Days 1 and 3, or on Days 1, 3, and 5, in pediatric cancer patients receiving multi-day highly emetogenic chemotherapy.[1]

Part II is double-blind, which means the treatment assignment is hidden, and it tests efficacy, non-inferiority, and safety in repeated cycles.[1]

Who can participate

The study is designed for pediatric cancer patients, meaning children and teenagers with cancer.[1]

For the pharmacokinetic part, the age range is from 3 months up to under 18 years in one cohort, and under 3 months in another cohort as described in the study summary.[1]

For the efficacy comparison in Part II, the age range is from 6 months up to under 18 years.[1]

All participants are receiving highly emetogenic chemotherapy, which is the type of chemotherapy the study is trying to support with nausea and vomiting prevention.[1]

What is being measured

The main outcome in Part II is the proportion of patients with complete response (CR) during the delayed phase of emesis, which means no vomiting episodes and no rescue medicine between more than 24 hours and 120 hours after chemotherapy starts.[1]

In Part I, the main measurements are netupitant exposure values such as Cmax, AUClast, and AUCinf, which help researchers understand how much drug is in the body and for how long.[1]

Safety is checked through reports of adverse events, physical examinations, vital signs, clinical laboratory tests, and 12-lead ECGs, which are heart rhythm recordings.[1]

Comparators and study treatments

Part II compares IV NEPA, which includes fosnetupitant chloride and palonosetron, with an active comparator made of IV fosaprepitant plus IV ondansetron.[1]

The study also includes sodium chloride injection as a control infusion in the listed interventions.[1]

The trial aims to show non-inferiority, meaning the new approach should not be meaningfully worse than the comparator for preventing delayed nausea and vomiting.[1]

What the trial results may mean

This trial is focused on whether 204-NETU can help prevent nausea and vomiting during and after highly emetogenic chemotherapy in children and teenagers.[1]

It also helps researchers learn whether repeated use is safe and how the drug behaves in younger patients, including very young children.[1]

Because the study includes both safety and efficacy outcomes, it is designed to answer two important questions: can the treatment be used safely, and does it work well enough to control delayed vomiting after chemotherapy?[1]

Trial ID Phase Condition studied Status Enrollment
2024-514321-39-00 Phase 4 Chemotherapy-induced nausea and vomiting in pediatric cancer patients receiving highly emetogenic chemotherapy Authorised 120

FAQ

  • What are the 204-NETU trials studying? They are studying whether 204-NETU can help prevent chemotherapy-induced nausea and vomiting in pediatric cancer patients. The trials also measure safety and, in one part, how much of the drug is present in the body.
  • Who can take part in these studies? The studies include pediatric cancer patients. One part includes patients from 3 months up to under 18 years, and another part includes patients from 6 months up to under 18 years.
  • What phase are these trials? The trial is in Phase 4. This means it is being studied in a more real-world setting after earlier research has already been done.
  • What conditions are being treated in the trials? The condition being studied is chemotherapy-induced nausea and vomiting, often called CINV. The trials focus on children receiving highly emetogenic chemotherapy, which is chemotherapy that is more likely to cause vomiting.
  • What results are the researchers measuring? They measure drug exposure in the body, safety checks such as blood tests and ECGs, and how many patients have complete control of vomiting without needing rescue medicine. They also compare 204-NETU with active comparator treatments.

Ongoing Clinical Trials on 204-NETU

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

    Recruiting

    4 1 1
    Investigated diseases:
    Investigated drugs:
    Greece Poland Romania

Glossary

  • Chemotherapy-induced nausea and vomiting (CINV): Nausea and vomiting caused by cancer treatment with chemotherapy.
  • Highly emetogenic chemotherapy (HEC): Chemotherapy that has a high chance of causing vomiting.
  • Pediatric cancer patients: Children and teenagers who have cancer.
  • Phase 4: A later stage of research done after earlier studies, often to learn more about safety and how a treatment works in practice.
  • Open-label: A study design where the treatment is known to the researchers and sometimes the participants.
  • Double-blind: A study design where neither the participant nor the researcher knows which treatment is given, to reduce bias.
  • Pharmacokinetic: A study of how the body absorbs, moves, and removes a drug.
  • Safety and tolerability: How well a treatment is handled by the body and what side effects or problems may happen.
  • Efficacy: How well a treatment works.
  • Non-inferiority: A test to see if one treatment is not worse than another by more than a small amount.
  • Complete response (CR): In this study, no vomiting episodes and no need for rescue medicine during the measured time period.
  • ECG: A heart test that records the electrical activity of the heart.

References

  1. https://clinicaltrials.gov/study/2024-514321-39-00