Table of Contents

• Trial overview
• Who is being studied
• Study design and phase
• Treatments being tested
• Main outcomes and endpoints
• Trial status and size

Trial overview

The available trial is a Phase I/II study of Meclofenamate Sodium in people with progressive MGMT-methylated glioblastoma.^[1] It is titled “Phase I/II trial of meclofenamate in progressive MGMT-methylated glioblastoma under temozolomide second-line therapy (MecMeth/ NOA-24).”^[1]

The study is designed to learn whether Meclofenamate Sodium can be used safely with standard temozolomide and whether the combination may help control the cancer.^[1] The brief summary says Phase I focuses on toxicity and dose selection, while Phase II focuses on efficacy, meaning how well the treatment works.^[1]

Who is being studied

This trial targets patients with glioblastoma, which is a fast-growing brain cancer.^[1] The condition is described more specifically as progressive MGMT-methylated glioblastoma, meaning the cancer is getting worse and has a certain tumor feature called MGMT methylation.^[1]

The source data do not give a full list of eligibility rules, such as age limits or prior treatments.^[1] What is clear is that the study is focused on a narrow patient group with progressive disease and a specific tumor marker.^[1]

Study design and phase

This is an interventional trial, which means the researchers assign a treatment and then measure the results.^[1] It is described as Phase I/II in the title, and the phase field lists Phase 2.^[1]

In Phase I, the main purpose is to find the daily Meclofenamate Sodium dose that can be recommended for the next stage of the study.^[1] In Phase II, the main purpose is to test whether adding Meclofenamate Sodium to standard therapy improves outcomes.^[1]

Treatments being tested

The study includes Meclofenamate Sodium given by mouth and temozolomide given by mouth.^[1] The intervention list names Meclofenamate 50 and Meclofenamate 100, and both are listed at 400 mg oral dosing in the source data.^[1]

Temozolomide is used as the standard treatment in the study, and Meclofenamate Sodium is added on top of it.^[1] The trial is therefore testing a combination approach rather than Meclofenamate Sodium alone.^[1]

Main outcomes and endpoints

The primary outcome in Phase I 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 serious enough to affect how much treatment can be given.^[1]

The primary outcome in Phase II is progression-free survival, measured from randomization until the tumor is found to be progressing on MRI using RANO criteria at the local center.^[1] Progression-free survival means the time before the cancer gets worse.^[1]

The study also states that, in a sensitivity analysis, Phase II may include some Phase I patients who received the same Meclofenamate Sodium dose used in Phase II, with progression-free survival measured from trial entry.^[1] A sensitivity analysis is an extra check to see whether the results stay similar under a slightly different way of counting the data.^[1]

Trial status and size

The trial status is Authorised.^[1] The planned enrollment is 72 participants.^[1]

Because the study is still in the trial stage, the main question is not whether Meclofenamate Sodium is already proven to work, but whether it is safe enough and promising enough to continue testing in this specific group of patients.^[1]