Evaluation of Alpelisib and Trametinib Combination Therapy in Patients with Progressive Refractory Meningiomas

The primary objective of the study is to evaluate the efficacy of the combination of **Alpelisib** and **Trametinib** in patients with progressive refractory **meningiomas**. This is clinically relevant as meningiomas are common intracranial tumors, and treatment options for refractory cases are limited. The study aims to determine whether this combination therapy can provide a therapeutic benefit in terms of tumor control or reduction, potentially offering a new treatment avenue for patients with limited options.

The clinical trial involves participants diagnosed with **meningiomas**, a type of brain tumor. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or specific lifestyle considerations such as diet, physical activity, or habits. The selection criteria for the trial population have not been disclosed, and no principal inclusion or exclusion criteria have been specified. The general health status of the participants is not detailed in the available data.

The clinical trial is designed to evaluate the combination of **alpelisib** and **trametinib** in patients with progressive refractory **meningiomas**. This study is a Phase 1 trial, which typically focuses on assessing the safety, tolerability, and optimal dosing of the investigational treatment. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated recruitment start date was September 25, 2019, and the trial is expected to conclude by December 25, 2025, indicating a total duration of approximately six years.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to determine eligibility based on predefined criteria. Following successful screening, participants will be randomized to receive either the investigational treatment or a control. Throughout the trial, regular follow-up visits will be scheduled to monitor the participants' health, assess treatment efficacy, and record any adverse events. These visits are crucial for collecting data on the primary and secondary endpoints of the study. The end-of-study visit will mark the conclusion of a participant's involvement, during which final assessments will be conducted to gather comprehensive data on the treatment's impact.

The expected length of participant involvement will vary depending on individual response to treatment and the occurrence of any adverse events. Conditions that may lead to early termination from the study include significant adverse reactions, withdrawal of consent, or any other medical reasons deemed necessary by the investigators. The trial's design and procedures are structured to ensure the safety and well-being of participants while providing valuable insights into the potential therapeutic benefits of the investigational treatment for meningiomas.

The clinical trial documentation does not provide specific details regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration. As such, no detailed description of the experimental treatment can be provided based on the available data.

Similarly, there is no information available about any non-experimental treatments used in the study, such as standard-of-care therapy, placebo, or comparator treatment. Consequently, no description of these treatments can be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the source data. Therefore, no further details can be offered regarding these aspects of the clinical trial.

The clinical trial is in Phase 1, with an estimated recruitment start date of September 25, 2019, and an estimated end date of December 25, 2025. Efficacy assessment details, including specific parameters or endpoints, methods, and schedules for measuring, collecting, and analyzing efficacy data, are not provided in the available data. The trial's primary and secondary endpoints, as well as the main objective, are not specified. The trial is categorized under trial category ID 61830. Further information regarding the tools or instruments used for efficacy assessments is not available.