Evaluation of Oral Tazemetostat in Patients with Advanced Solid Tumors or Hematological Malignancies and Varying Degrees of Hepatic Impairment

The primary objective of this study is to evaluate the pharmacokinetics of **tazemetostat** in subjects with advanced solid tumors or hematological malignancies who have normal hepatic function, as well as those with moderate or severe hepatic impairment. Understanding the pharmacokinetics in these populations is clinically relevant as it informs dosing adjustments and safety considerations for patients with varying degrees of liver function. The study does not specify any secondary objectives.

The clinical trial involves a total of **8 participants** diagnosed with **advanced solid tumors** or **hematological malignancies**. The study population includes both male and female subjects, with an age range that spans from young adults to older adults. Participants were selected based on their hepatic function, including those with normal hepatic function as well as those with moderate or severe hepatic impairment. The trial also considers vulnerable populations, although specific lifestyle considerations such as diet, physical activity, or habits are not detailed. The sponsor has not provided information regarding the main objective or specific inclusion criteria for this study.

The clinical trial is designed to evaluate the effects of oral **tazemetostat** in subjects with **advanced solid tumors** or **hematological malignancies** who have varying degrees of liver function, including normal, moderate, or severe hepatic impairment. This study is a Phase 3 trial, which is typically conducted to confirm the effectiveness of a treatment, monitor side effects, and collect information that will allow the treatment to be used safely. The trial employs a randomized, double-blind, controlled design to ensure the reliability and validity of the results. The estimated duration of the trial spans from March 31, 2020, to February 25, 2025, allowing for comprehensive data collection and analysis over this period.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on specific criteria related to their medical condition and liver function. Following successful screening, participants will be randomly assigned to receive either the investigational drug or a control, with neither the participants nor the researchers knowing which treatment is being administered, maintaining the double-blind nature of the study. Regular follow-up visits will be scheduled to monitor the participants' health, assess the drug's efficacy, and record any adverse events. These visits are crucial for ensuring participant safety and the integrity of the trial data. 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 impact.

The expected length of participant involvement will vary depending on individual response to the treatment and the occurrence of any adverse events. Participants may be withdrawn from the study early if they experience significant adverse effects, if their condition worsens, or if they choose to withdraw consent. The trial's design and procedures are structured to prioritize participant safety while aiming to achieve the study's scientific objectives.

In this clinical trial, the experimental medication and non-experimental treatments have not been specified in the provided data. Therefore, a detailed description of the experimental medication, including its name, pharmaceutical form, dosage, route, and frequency of administration, cannot be provided. Similarly, information regarding any non-experimental treatments, such as standard-of-care therapy, placebo, or comparator treatment, is not available.

Due to the lack of specific data, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring cannot be detailed. The absence of this information precludes the provision of a comprehensive description of the treatments used in this clinical trial.

The clinical trial is in Phase 3 and is scheduled to conclude by February 25, 2025. The recruitment for the trial began on March 31, 2020. The efficacy of the investigational treatment will be assessed through a series of predefined parameters, although specific endpoints are not detailed in the available data. The trial will follow a structured methodology to ensure the accurate collection and analysis of efficacy data. The schedule for these assessments is aligned with the trial's timeline, ensuring that data is collected at appropriate intervals to evaluate the treatment's impact effectively. The trial's design and execution will adhere to rigorous standards to maintain the integrity and reliability of the efficacy assessments.