Evaluation of Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Inavolisib with Paclitaxel in Locally Advanced or Metastatic Solid Tumors

The primary objective of this study is to evaluate the **safety**, **tolerability**, **pharmacokinetics**, and preliminary anti-tumor activity of inavolisib in combination with paclitaxel in patients with **locally advanced or metastatic solid tumors**. This is clinically relevant as it aims to determine the potential therapeutic benefits and risks associated with this combination treatment, which could inform future therapeutic strategies for managing advanced solid tumors.

The clinical trial involves a total of **76 participants** diagnosed with **locally advanced or metastatic solid tumors**. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected to include a vulnerable population, although specific criteria for vulnerability are not detailed. The trial does not specify particular lifestyle considerations such as diet or physical activity. The selection process for the trial population is not explicitly described, and no principal inclusion or exclusion criteria are provided. The study aims to gather data from a diverse group of individuals within the specified age range and health condition.

The clinical trial is designed to evaluate the **safety**, tolerability, pharmacokinetics, and preliminary anti-tumor activity of Inavolisib in combination with Paclitaxel in patients with **locally advanced or metastatic solid tumors**. This study is a Phase 3 trial, employing a randomized, double-blind, and controlled design to ensure the reliability and validity of the results. The trial is expected to commence recruitment on June 15, 2021, and is projected to conclude by October 30, 2025, providing a comprehensive evaluation period.

Participants will undergo a series of 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. Regular follow-up visits will be scheduled to monitor the participants' response to the treatment, assess any adverse effects, and ensure adherence to the study protocol. These visits are crucial for collecting data on the pharmacokinetics and anti-tumor activity of the investigational combination therapy. The end-of-study visit will mark the conclusion of the participant's involvement, where final assessments will be conducted to gather comprehensive data on the treatment's efficacy and safety.

The expected length of participant involvement will vary depending on individual response and tolerance to the treatment, but it is anticipated to span several months. Conditions that may lead to early termination from the study include significant adverse reactions, disease progression, or withdrawal of consent by the participant. The trial's structured approach and rigorous methodology aim to provide valuable insights into the potential benefits and risks of the investigational therapy for patients with locally advanced or metastatic solid tumors.

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 the administration of other medicinal products or their role in the trial.

Due to the lack of available data, further information on drug administration, dosing schedules, and participant compliance monitoring cannot be described. The trial documentation does not include any additional relevant information regarding the substances involved in the study.

The clinical trial is designed to assess efficacy in a Phase 3 study. The trial is scheduled to commence recruitment on June 15, 2021, with an estimated completion date of October 30, 2025. The efficacy assessment will be conducted through a series of pre-defined parameters, although specific endpoints and methods for measuring efficacy are not detailed in the provided data. The trial will follow a structured timeline to ensure systematic data collection and analysis, adhering to the rigorous standards expected in a Phase 3 clinical trial. The focus will be on evaluating the treatment's impact on the specified medical condition, utilizing appropriate scientific methodologies to ensure the reliability and validity of the results.