In short
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.
Key points
- Clinical trials investigating IDROXIOLEIC ACID are focused on newly diagnosed primary glioblastoma multiforme, a serious brain cancer. The available trial is a Phase 4 interventional study with 140 participants. It is testing IDROXIOLEIC ACID together with standard care, including radiotherapy and TMZ. The main outcomes are progression-free survival and overall survival. The study also uses RANO criteria and review by an imaging committee to confirm whether the disease has progressed.
Trial overview
The available study is an interventional trial, which means researchers are giving a treatment and then measuring what happens. It is authorised and is studying IDROXIOLEIC ACID in people with newly diagnosed primary glioblastoma multiforme.
Who is being studied
This trial targets patients with newly diagnosed primary glioblastoma multiforme, often shortened to ndGBM in the source data. This means the study is focused on people who have just been found to have this type of brain cancer.
Treatments being tested
The study is testing IDROXIOLEIC ACID, listed in the trial as 2-Hydroxyoleic acid sodium salt, together with standard treatment. The standard treatment in the trial includes radiotherapy and TMZ, which is temozolomide in the source data. A placebo is also listed, which is an inactive treatment used for comparison.
Study phase and design
This is a Phase 4 study with an enrollment of 140 participants. Phase 4 studies are later-stage trials, often used to learn more about how a treatment performs in a larger group of patients. 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.
What the trial measures
The main outcome is progression-free survival, or PFS, measured using RANO criteria after at least 66 PFS events occur. PFS means the time before the cancer gets worse. The trial also measures overall survival, or OS, after at least 90 OS events are observed. OS means the length of time people stay alive after treatment starts.
How results are checked
The source data say that progression is first judged by the investigator using local image review and other clinical information. After that, an adjudication/imaging committee confirms the progression, which helps make the result more reliable. 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.