Europas førende søgning efter kliniske forsøg

Meclofenamate Sodium

Clinical trials are investigating Meclofenamate Sodium in people with progressive MGMT-methylated glioblastoma. These studies look at safety, dose finding, and whether the treatment helps when added to standard temozolomide. The main target group is adults with this type of brain tumor.

Table of contents

Trial overview

The study called MecMeth/ NOA-24 is a Phase 2 interventional trial of Meclofenamate Sodium in people with progressive MGMT-methylated glioblastoma.[1] The trial is authorised and plans to include 72 participants.[1]

This trial tests Meclofenamate Sodium together with standard temozolomide, which means the researchers are looking at the added effect of Meclofenamate Sodium on top of usual treatment.[1]

Study design and phases

The study has two parts.[1] In Phase I, the main goal is to check safety and find the dose that should be used in Phase II.[1] In Phase II, the main goal is to see whether the treatment works better when Meclofenamate Sodium is added to standard therapy.[1]

Participants may receive Meclofenamate 50 or Meclofenamate 100, both listed as oral treatment, along with temozolomide.[1] The trial data do not explain the difference between the dose labels beyond the names used in the study record.[1]

Who can participate

The target population is people with progressive glioblastoma that is MGMT-methylated.[1] The source data do not give more detailed inclusion or exclusion rules, so only this main patient group can be confirmed from the trial record.[1]

Because the study is about second-line therapy, it is focused on patients whose disease is being treated after earlier treatment has not been enough.[1]

What is being measured

In Phase I, the main endpoint is the incidence of dose-limiting toxicities during the first 8 weeks, or 56 days, of Meclofenamate Sodium treatment.[1] Dose-limiting toxicities are side effects that are serious enough to affect how much treatment can be given.[1]

In Phase II, the main endpoint is progression-free survival, which is measured from randomization until progressive disease is found on MRI using RANO criteria in the local center.[1] Progression-free survival means the time a patient lives without the cancer getting worse.[1]

The study also includes a sensitivity analysis, which is an extra way to check the results.[1] This analysis also includes some Phase I patients if they received the same Meclofenamate Sodium dose used in Phase II, with progression-free survival measured from trial inclusion.[1]

Main aims of the trial

The Phase I aim is to understand toxicity and choose the daily Meclofenamate Sodium dose that can be recommended for Phase II.[1] The Phase II aim is to test whether adding Meclofenamate Sodium to standard therapy improves outcomes in this patient group.[1]

In simple terms, the researchers want to learn two main things: first, whether the treatment can be given safely enough, and second, whether it may help delay tumor growth in progressive MGMT-methylated glioblastoma.[1]

Trial ID Phase Condition studied Status Enrollment
2024-511264-89-00 Phase 2 Progressive MGMT-methylated glioblastoma Authorised 72

FAQ

  • What is being studied in the Meclofenamate Sodium trial? The trial is studying Meclofenamate Sodium together with standard temozolomide in progressive MGMT-methylated glioblastoma. It looks at both safety and how well the treatment may work.
  • Who can participate in this trial? The target group is people with progressive MGMT-methylated glioblastoma. The trial data do not list more detailed eligibility rules.
  • What phase is this trial? This is a Phase 2 trial with an initial Phase I part. Phase I focuses on safety and dose finding, and Phase II focuses on treatment effect.
  • What outcome measures are used? Phase I measures dose-limiting toxicities during the first 8 weeks. Phase II measures progression-free survival, which means the time until the tumor gets worse on MRI.
  • What is the status of the trial? The trial status is Authorised. It is an interventional study with 72 planned participants.

Igangværende kliniske forsøg for Meclofenamate Sodium

  • Test af ny kombinationsbehandling med meclofenamat og temozolomid mod tilbagevendende hjernetumor (glioblastom)

    Rekrutterer

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tyskland

Ordliste

  • Glioblastoma: A fast-growing type of brain tumor. In this trial, the study focuses on people with progressive disease.
  • MGMT-methylated: A tumor feature found by testing the tumor tissue. It describes a specific group of glioblastoma patients in this study.
  • Progressive disease: Cancer that is getting worse or growing despite treatment.
  • Temozolomide: The standard treatment given in this trial together with Meclofenamate Sodium.
  • Phase I: The first part of a trial, usually used to check safety and find a suitable dose.
  • Phase II: The part of a trial that looks more closely at whether the treatment may help.
  • Dose-limiting toxicities: Side effects serious enough to limit how much treatment can be given.
  • Progression-free survival: The time during which a patient lives without the tumor getting worse.
  • MRI: A scan that makes detailed pictures of the inside of the body. In this trial, it is used to check whether the tumor has progressed.
  • RANO criteria: A set of rules used to judge whether a brain tumor has progressed on scans.
  • Interventional study: A study where participants receive a treatment that the researchers are testing.

Referencer

  1. https://clinicaltrials.gov/study/2024-511264-89-00