Evaluation of Safety and Efficacy of Targeted Therapies in Metastatic Colorectal Cancer Subpopulations

The primary objective of this study is to evaluate the **safety** and **efficacy** of targeted therapies in subpopulations of patients with **metastatic colorectal cancer**. This is clinically relevant as metastatic colorectal cancer represents a significant therapeutic challenge, and targeted therapies may offer improved outcomes by addressing specific molecular characteristics of the disease. The study aims to provide insights into the potential benefits and risks associated with these therapies, thereby informing treatment decisions and potentially improving patient prognosis.

The clinical trial involves a total of **240 participants** diagnosed with **metastatic colorectal cancer**. The study population includes both male and female subjects, with an age range encompassing adults and older adults. Participants were selected to ensure a representative sample of the general population affected by this condition. The trial includes individuals from a vulnerable population, highlighting the importance of ethical considerations in the study design. While specific lifestyle factors such as diet, physical activity, or habits are not detailed, the inclusion of a diverse age range and both genders suggests a comprehensive approach to understanding the disease's impact across different demographics. The sponsor has not provided detailed information on the main objective or specific inclusion criteria for this trial.

The clinical trial is designed to evaluate the safety and efficacy of targeted therapies in subpopulations of patients with **metastatic colorectal cancer**. This study is structured as a Phase 3, randomized, double-blind, controlled trial. The trial commenced on October 25, 2021, and is projected to conclude on November 7, 2028. Participants will be involved in the study for a duration that aligns with the trial's overall timeline, subject to individual response and adherence to protocol requirements.

The sequence of study visits begins with an inclusion visit, also known as the screening visit, where potential participants are assessed for eligibility based on predefined criteria. Following successful inclusion, participants will undergo a series of follow-up visits at regular intervals. These visits are designed to monitor the participants' response to the treatment, assess any adverse effects, and ensure compliance with the study protocol. The end-of-study visit marks the final assessment, where comprehensive evaluations are conducted to gather data on the long-term effects and overall outcomes of the treatment.

Participants are expected to remain in the study for its entire duration unless specific conditions necessitate early termination. Such conditions may include significant adverse reactions, non-compliance with the study protocol, or withdrawal of consent by the participant. The trial's design ensures that all procedures are conducted in accordance with ethical standards and regulatory requirements, maintaining the integrity and scientific validity of the research.

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 these details limits the ability to describe the treatment regimen comprehensively.

The clinical trial is in Phase 3 and is scheduled to have an estimated recruitment start date of October 25, 2021, with an estimated end date of November 7, 2028. The efficacy of the investigational treatment will be assessed through a series of predefined parameters, although specific endpoints are not detailed in the provided data. The trial will likely involve systematic collection and analysis of efficacy data at various timepoints throughout the study duration. The methods and tools for measuring efficacy, such as validated scales or laboratory tests, are not specified in the available information. The trial is categorized under trial category 1, with a trial category ID of 72412.