Table of contents
- Trial overview
- Who can participate
- Study goals and endpoints
- Trial design and phase
- What the study is trying to learn
Trial overview
The available clinical trial is titled Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent Glioblastoma (GBM) and is listed as Authorised.[1] It is an interventional study, which means researchers are testing treatments rather than only observing patients.[1] The condition studied is glioblastoma (GBM), a serious type of brain cancer.[1]
The trial includes people with both newly diagnosed and recurrent GBM.[1] Recurrent means the cancer has come back after treatment.[1] The planned enrollment is 1845 participants, showing that this is a large study.[1]
Who can participate
The source data say the target population is patients with newly diagnosed and recurrent glioblastoma.[1] This means the study is meant for people who have GBM at the time of diagnosis and for people whose GBM has returned.[1]
No other eligibility details are provided in the trial data, so the main known point is the diagnosis of GBM.[1]
Study goals and endpoints
The first goal is to identify experimental therapies that improve overall survival for GBM patients in the screening stage.[1] Overall survival means the time from randomization until death from any cause.[1]
The study also aims to find whether certain patient subtypes or biomarker signatures benefit more from treatment.[1] A biomarker is a measurable sign in the body that may help predict how a person responds to treatment.[1]
The main outcome listed is overall survival.[1] The brief summary also says the study will confirm promising therapies and biomarker signatures in an expansion stage designed to support a new drug application.[1]
Trial design and phase
This study is listed as Phase 4.[1] Phase 4 usually means the treatment is being studied in a later stage of research, after earlier testing has already taken place.[1]
The trial is described as having a screening stage and an expansion stage.[1] In the screening stage, researchers look for signs that a treatment may work in certain groups of patients.[1] In the expansion stage, they test the promising approach further in more patients.[1]
The study is designed to evaluate multiple regimens, and the interventions listed in the source are ADI-PEG-20, Troriluzole, and AZD1390.[1] The trial record provided here does not link the substance 7-FLUORO-3-METHYL-8-[6-(3-PIPERIDIN-1-YLPROPOXY)PYRIDIN-3-YL]-1-PROPAN-2-YLIMIDAZO[4,5-C]QUINOLIN-2-ONE to a specific regimen in the trial details supplied.[1]
What the study is trying to learn
This trial is trying to answer two main questions: which treatments may improve survival, and which patient groups may benefit the most.[1] That is why the study looks not only at treatment results, but also at possible biomarker patterns.[1]
For patients and families, the key point is that this is a large GBM study focused on real clinical results, especially how long patients live after treatment assignment.[1] The trial is also trying to build evidence strong enough to support a later drug application if the findings are positive.[1]
