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IDROXIOLEIC ACID

Clinical trials investigating IDROXIOLEIC ACID are studying its use in newly diagnosed primary glioblastoma multiforme. The main goals are to evaluate efficacy and safety when it is added to standard treatment, with outcomes such as progression-free survival and overall survival.

Table of contents

Trial overview

The available study is an interventional trial, which means researchers are giving a treatment and then measuring what happens.[1] It is authorised and is studying IDROXIOLEIC ACID in people with newly diagnosed primary glioblastoma multiforme.[1]

Who is being studied

This trial targets patients with newly diagnosed primary glioblastoma multiforme, often shortened to ndGBM in the source data.[1] This means the study is focused on people who have just been found to have this type of brain cancer.[1]

Treatments being tested

The study is testing IDROXIOLEIC ACID, listed in the trial as 2-Hydroxyoleic acid sodium salt, together with standard treatment.[1] The standard treatment in the trial includes radiotherapy and TMZ, which is temozolomide in the source data.[1] A placebo is also listed, which is an inactive treatment used for comparison.[1]

Study phase and design

This is a Phase 4 study with an enrollment of 140 participants.[1] Phase 4 studies are later-stage trials, often used to learn more about how a treatment performs in a larger group of patients.[1] The brief summary says the study has an adaptive design, which means some parts of the study plan can be adjusted while the trial is running.[1]

What the trial measures

The main outcome is progression-free survival, or PFS, measured using RANO criteria after at least 66 PFS events occur.[1] PFS means the time before the cancer gets worse.[1] The trial also measures overall survival, or OS, after at least 90 OS events are observed.[1] OS means the length of time people stay alive after treatment starts.[1]

How results are checked

The source data say that progression is first judged by the investigator using local image review and other clinical information.[1] After that, an adjudication/imaging committee confirms the progression, which helps make the result more reliable.[1] The study is designed to look for a wide range of treatment effect through sample size re-estimation, which means the researchers can review whether the planned number of patients is still appropriate for the study goals.[1]

Trial ID Phase Condition studied Status Enrollment
2024-511542-39-00 Phase 4 Newly diagnosed primary glioblastoma multiforme Authorised 140

FAQ

  • What condition is being studied in the IDROXIOLEIC ACID trial? The trial is studying newly diagnosed primary glioblastoma multiforme, which is a fast-growing brain cancer.
  • Who can take part in this trial? The trial is focused on patients with newly diagnosed primary glioblastoma multiforme. The source data do not list more detailed eligibility rules.
  • What is the main goal of the study? The study aims to see whether IDROXIOLEIC ACID adds benefit to standard care. It measures how long patients live without the cancer getting worse and how long they survive overall.
  • What phase is the trial? This is a Phase 4 trial. Phase 4 studies usually look at a treatment in a larger patient group after earlier testing.
  • What results are the researchers measuring? The main results are progression-free survival and overall survival. Progression-free survival means the time before the disease gets worse, and overall survival means the time patients stay alive after treatment starts.

Ongoing Clinical Trials on IDROXIOLEIC ACID

  • Study on the Safety and Effectiveness of 2-Hydroxyoleic Acid and Temozolomide with Radiotherapy for Patients with Newly Diagnosed Glioblastoma

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Italy Spain

Glossary

  • Glioblastoma: A fast-growing type of brain cancer.
  • Newly diagnosed: Found for the first time recently.
  • Primary glioblastoma multiforme: A glioblastoma that starts in the brain and is not a return of an earlier tumor.
  • Interventional study: A study where researchers give a treatment and watch what happens.
  • Phase 4: A late-stage trial that studies a treatment in a real-world setting or in more patients.
  • Standard of care: The usual treatment that doctors commonly use for a disease.
  • Radiotherapy: Treatment that uses radiation to kill cancer cells.
  • TMZ: A short name used in the trial data for temozolomide, part of the standard treatment.
  • Progression-free survival: The length of time during and after treatment that the cancer does not get worse.
  • Overall survival: The length of time patients stay alive after treatment begins.
  • RANO criteria: A set of rules used to judge whether a brain tumor is getting better, stable, or worse.
  • Adjudication/imaging committee: A review group that checks scans and confirms whether the disease has progressed.

References

  1. https://clinicaltrials.gov/study/2024-511542-39-00