Evaluation of Safety and Efficacy of Novel Targeted Therapy Combinations in Adults with Advanced or Metastatic BRAF V600 Colorectal Cancer

The primary objective of this study is to evaluate the **safety** and **efficacy** of novel targeted therapy combinations in adult patients with advanced or metastatic **colorectal cancer**. This is clinically relevant as it aims to improve treatment outcomes for patients with this aggressive form of cancer, specifically those with the **BRAF V600** mutation, which is known to be associated with poor prognosis and limited treatment options.

The clinical trial involves a total of **39 participants** diagnosed with **advanced or metastatic BRAF V600 colorectal cancer**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults, specifically categorized under age groups 3 and 4. Participants were selected to include a vulnerable population, although specific inclusion or exclusion criteria were not provided by the sponsor. The trial does not specify any particular lifestyle considerations such as diet, physical activity, or habits. The selection process aimed to encompass a diverse demographic to ensure comprehensive data collection and analysis.

The clinical trial is designed to evaluate the **safety** and efficacy of novel targeted therapy combinations in adult patients diagnosed with advanced or metastatic **BRAF V600 colorectal cancer**. This study is a Phase 3, randomized, double-blind, controlled trial, which aims to provide robust data on the therapeutic potential of the investigational treatments. The trial commenced recruitment on July 22, 2022, and is projected to conclude by September 20, 2024, encompassing a total duration of approximately 26 months.

Participants will undergo a series of structured study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Following successful screening, participants will be randomized into treatment groups. The trial includes multiple follow-up visits to monitor patient safety, treatment efficacy, and any adverse events. These visits are scheduled at regular intervals throughout the study period. The end-of-study visit will occur after the final treatment cycle, where comprehensive assessments will be conducted to evaluate the overall outcomes of the trial.

The expected length of participant involvement in the study is contingent upon the treatment regimen and response, with the possibility of early termination if specific conditions arise. These conditions may include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial is conducted under strict ethical guidelines, ensuring that participant safety and data integrity are maintained throughout the study duration.

No specific information regarding the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, is available from the provided data. Consequently, a detailed description of the experimental treatment cannot be provided.

Similarly, there is no information available about any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, used in the study. Therefore, a description of these treatments cannot be included.

Additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not provided in the data. As such, these details cannot be elaborated upon in this context.

The clinical trial is a Phase 3 study with an estimated recruitment start date of July 22, 2022, and an estimated end date of September 20, 2024. The efficacy of the investigational treatment will be assessed through predefined parameters or endpoints, although specific endpoints are not detailed in the available data. The trial will follow a structured schedule for measuring, collecting, and analyzing these efficacy parameters, adhering to the rigorous standards typical of Phase 3 trials. The methods and tools for efficacy assessment are not specified in the provided information. The trial is categorized under trial category 1, with a trial category ID of 33579, indicating its classification within the clinical trial framework.