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ULIXERTINIB

Clinical trials are investigating ULIXERTINIB in children with progressive, relapsed, or refractory pediatric low-grade glioma (pLGG). These studies look at how well ULIXERTINIB works in combination treatment plans and how safe and active the regimens are. The main goal is to find promising treatment options for this patient group.

Table of Contents

Clinical trials overview

The authorised trial listed here is a Phase I/II combination umbrella trial in children with progressive, relapsed, or refractory pediatric low-grade glioma (pLGG).[1] The study is called EPILOGUE and is designed to find promising single-agent or combination treatment regimens for this patient group.[1]

Who can participate

This trial is for pediatric patients with pLGG that is progressive, relapsed, or refractory.[1] In simple terms, this means the tumor has grown, come back after treatment, or has not responded well to treatment.

Study design and treatment approach

The study is interventional, which means researchers give study treatment and then measure the results.[1] It uses a multi-arm umbrella design, so several treatment paths are tested within one trial.[1] The trial also uses an intra-individual dose escalation concept, meaning the dose may be increased step by step for each patient to help find the best dose for safety and activity.[1]

ULIXERTINIB is listed as an oral study drug in this trial, and it is being studied with other treatments such as vinblastinsulfat Teva® and tovorafenib.[1] The brief summary states that the aim is to identify promising single-agent or combination-based regimens and to reach the optimal dose for each patient.[1]

What the trial measures

The main safety outcome is dose-limiting toxicity (DLT) of the combination treatment regimens.[1] A DLT is a side effect serious enough to limit treatment dose.

The main activity outcome is best response, including complete response (CR) or partial response (PR), based on RAPNO-LGG criteria.[1] These responses are assessed for each patient during the study treatment period, up to a maximum of 12 cycles, with checks every 8 weeks and central review.[1]

Trial details at a glance

The trial is authorised, has a planned enrollment of 56 participants, and is in Phase 1.[1] Its focus is on finding safe and active treatment combinations for children with pLGG whose disease is difficult to treat.[1]

Trial IDPhaseCondition StudiedStatusEnrollment
2024-516896-34-00Phase 1Progressive/relapsed/refractory pediatric low-grade glioma (pLGG)Authorised56

FAQ

  • What is ULIXERTINIB being studied for in these trials? ULIXERTINIB is being studied as part of treatment regimens for progressive, relapsed, or refractory pediatric low-grade glioma (pLGG). The trial is looking for treatment plans that may be safe and active for these children.
  • Who can join the ULIXERTINIB trial? The trial is for pediatric patients with progressive, relapsed, or refractory pLGG. This means children whose tumor has grown, returned, or not responded well to earlier treatment.
  • What phase is the ULIXERTINIB study? This study is a Phase 1 trial. Phase 1 studies mainly focus on safety, dose finding, and early signs of activity.
  • What are the main results the trial is measuring? The trial is measuring dose-limiting toxicities, called DLTs, which are side effects that limit treatment dose. It is also measuring best response, such as complete response or partial response, using RAPNO-LGG criteria.
  • Is ULIXERTINIB being tested alone or with other drugs? In this trial, ULIXERTINIB is part of combination treatment regimens. Other study drugs listed are vinblastinsulfat and tovorafenib.

Ongoing Clinical Trials on ULIXERTINIB

  • A study of ulixertinib, tovorafenib, and vinblastine sulfate for children with progressive, relapsed, or refractory low-grade glioma

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Czechia Denmark Germany Sweden

Glossary

  • Pediatric low-grade glioma (pLGG): A slow-growing brain or spinal cord tumor in children. It can still cause serious problems if it grows, returns, or does not respond to treatment.
  • Progressive disease: Cancer or tumor that is getting worse or growing during or after treatment.
  • Relapsed: A disease that came back after a period of improvement.
  • Refractory: A disease that does not respond well to treatment.
  • Interventional study: A study where researchers give a treatment and then watch what happens.
  • Phase 1: An early stage of a clinical trial that mainly checks safety and helps find the right dose.
  • Umbrella trial: A study design that tests different treatment options in one trial for a related disease group.
  • Dose escalation: A step-by-step increase in treatment dose to find the best dose that is still safe.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to limit how much treatment can be given.
  • Best response: The best level of tumor improvement seen during the study.
  • Complete response (CR): No visible sign of the tumor on scans or tests.
  • Partial response (PR): The tumor has gotten smaller, but not gone away completely.
  • RAPNO-LGG criteria: A set of rules used to judge how well a low-grade glioma treatment is working in children.

References

  1. https://clinicaltrials.gov/study/2024-516896-34-00