Evaluation of Ripretinib on Pharmacokinetics of Midazolam in Patients with Advanced Gastrointestinal Stromal Tumor

The primary objective of this study is to evaluate the effects of **ripretinib** on the pharmacokinetics of **midazolam** in individuals diagnosed with **Advanced Gastrointestinal Stromal Tumor**. Understanding these effects is clinically relevant as it may inform dosing strategies and potential drug interactions, thereby optimizing therapeutic outcomes for patients with this condition.

The clinical trial involves participants diagnosed with **Advanced Gastrointestinal Stromal Tumor**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial population selection criteria include a focus on a vulnerable population, although specific inclusion or exclusion criteria are not provided. The sponsor has not disclosed the total number of participants involved in the study. Information regarding lifestyle considerations such as diet, physical activity, or habits is not available. The trial aims to gather data from a diverse group of individuals to ensure comprehensive results.

The clinical trial is designed to evaluate the effects of **ripretinib** on the pharmacokinetics of midazolam in individuals diagnosed with **advanced gastrointestinal stromal tumor**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The estimated duration of the trial spans from the recruitment start date on September 18, 2023, to the anticipated end date on November 29, 2025. Participants will be involved in a series of study visits, beginning with an inclusion visit, which serves as a screening to confirm eligibility based on predefined criteria. Subsequent follow-up visits will be scheduled to monitor the participants' response to the treatment and to collect necessary data. The trial will conclude with an end-of-study visit, where final assessments will be conducted to evaluate the overall outcomes of the intervention.

The expected length of participant involvement will vary depending on individual response and adherence to the study protocol. Conditions that may lead to early termination from the study include adverse reactions to the study drug, non-compliance with study procedures, or withdrawal of consent by the participant. Throughout the trial, data will be collected and analyzed to determine the primary and secondary endpoints, although specific endpoints are not detailed in the available data. The trial aims to contribute valuable insights into the treatment of advanced gastrointestinal stromal tumors, with a focus on the interaction between ripretinib and midazolam.

The clinical trial documentation does not provide specific details regarding the **experimental medication** used in the study. Information such as the name, pharmaceutical form, dosage, route, and frequency of administration is not available. Additionally, there is no data on whether the medication is a **paediatric formulation** or if it is classified as an **orphan drug**. The maximum daily dose, total dose, and treatment period are also unspecified.

Details about any **non-experimental treatments** used in the study, such as standard-of-care therapy, placebo, or comparator treatment, are not provided. There is no information on additional relevant aspects of drug administration, dosing schedules, or participant compliance monitoring. The absence of this data limits the ability to describe the treatments comprehensively.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on September 18, 2023, with an estimated completion date of November 29, 2025. The efficacy assessment will be conducted through a series of planned evaluations, although specific parameters or endpoints for efficacy evaluation are not detailed in the provided data. The trial will follow a structured methodology typical of Phase 3 studies, which generally involves rigorous data collection and analysis to determine the treatment's effectiveness. The trial's design and execution will adhere to established clinical protocols to ensure the reliability and validity of the efficacy outcomes.