Safety and Preliminary Efficacy of Azeliragon with Radiation and Temozolomide in Newly Diagnosed Glioblastoma Patients

The primary objective of this Phase I/II open-label study is to assess the **safety** and preliminary evidence of a therapeutic effect of Azeliragon when combined with conventional concurrent radiation and temozolomide in patients with newly diagnosed **glioblastoma**. Evaluating the safety profile of this combination therapy is clinically relevant as it may offer insights into potential treatment options for this aggressive brain tumor, which currently has limited therapeutic avenues. The study aims to determine whether the addition of Azeliragon can enhance the efficacy of the standard treatment regimen, potentially improving patient outcomes.

The clinical trial focuses on participants diagnosed with **glioblastoma**, a highly aggressive form of brain cancer. The study population includes both male and female subjects, with an age range encompassing adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants involved in the study. Selection criteria for the trial population, as well as any relevant lifestyle considerations such as diet, physical activity, or habits, have not been disclosed. Key inclusion or exclusion criteria are also not specified in the available data.

The clinical trial is designed as a **Phase I/II open-label study** to evaluate the safety and preliminary therapeutic effects of Azeliragon in combination with conventional concurrent radiation and temozolomide in patients with newly diagnosed **glioblastoma**. The trial is expected to commence recruitment on September 5, 2023, and is projected to conclude by June 30, 2026. Participants will be involved in the study for the duration of the trial unless early termination is warranted due to adverse events, withdrawal of consent, or other protocol-specified criteria.

The study will include a sequence of visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will undergo baseline assessments before the initiation of the treatment regimen. Throughout the trial, regular follow-up visits will be scheduled to monitor safety, treatment adherence, and preliminary efficacy outcomes. These visits will include clinical evaluations, laboratory tests, and imaging studies as necessary. The end-of-study visit will occur after the completion of the treatment phase, where final assessments will be conducted to evaluate the overall impact of the intervention.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is scheduled to commence recruitment on September 5, 2023, with an estimated completion date of June 30, 2026. The trial is categorized under phase 9, indicating an advanced stage of clinical research. Although specific efficacy parameters such as primary and secondary endpoints are not detailed, the trial will likely employ standard methodologies for measuring and analyzing efficacy outcomes. These may include validated scales, laboratory tests, or patient-reported outcomes, assessed at predetermined timepoints throughout the trial duration. The absence of explicit endpoints suggests that the trial may focus on comprehensive data collection to evaluate the therapeutic impact of the intervention under investigation. The trial's advanced phase implies a focus on confirming efficacy and safety in a larger population, potentially leading to regulatory approval and clinical application.