Pharmacokinetic and Safety Evaluation of Oral Decitabine and Cedazuridine in Patients with Solid Tumors, Myelodysplastic Syndrome, or Acute Myeloid Leukemia with Hepatic Impairment

The primary objective of this study is to evaluate the **pharmacokinetics** (PK) and safety of oral decitabine and cedazuridine in cancer patients with hepatic impairment. This is clinically relevant as hepatic impairment can significantly alter the metabolism and clearance of drugs, potentially affecting their efficacy and safety profiles. Understanding the PK and safety in this specific patient population is crucial for optimizing treatment regimens and ensuring patient safety. The study focuses on patients with **solid tumors**, **myelodysplastic syndrome (MDS)**, and **acute myeloid lymphoma (AML)**, conditions where these medications are commonly used. No secondary objectives are provided.

The clinical trial involves participants diagnosed with **solid tumors**, **myelodysplastic syndrome (MDS)**, or **acute myeloid lymphoma (AML)**. The study population includes both male and female subjects, with an age range that encompasses adults and older adults. The trial does not specifically target a vulnerable population. The sponsor has not provided information regarding the total number of participants or the selection process for the trial population. Additionally, there are no specific lifestyle considerations such as diet, physical activity, or habits mentioned for this study. Key inclusion or exclusion criteria have not been disclosed by the sponsor.

The clinical trial is designed to evaluate the pharmacokinetics and safety of oral **decitabine** and **cedazuridine** in patients with hepatic impairment who have been diagnosed with **solid tumors**, **myelodysplastic syndrome (MDS)**, or **acute myeloid lymphoma (AML)**. This is a Phase 3 trial, which is randomized, double-blind, and controlled to ensure the reliability and validity of the results. The trial is expected to run from June 20, 2022, to December 1, 2025, encompassing a comprehensive period for data collection and analysis.

Participants will undergo a series of study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. This initial visit will involve a thorough medical evaluation and baseline assessments. Following successful screening, participants will be randomized into treatment groups. Throughout the trial, there will be scheduled follow-up visits to monitor the participants' health, assess the drug's pharmacokinetics, and evaluate safety parameters. These visits are crucial for collecting ongoing data and ensuring participant safety. The trial will conclude with an end-of-study visit, where final assessments will be conducted to gather comprehensive data on the treatment's effects.

The expected length of participant involvement will vary depending on individual response and the trial's progression, but it is anticipated to last until the trial's end date unless specific conditions necessitate early termination. Such conditions may include adverse reactions, withdrawal of consent, or any other medical reasons deemed significant by the study investigators. The trial's design and procedures are structured to maintain scientific rigor while prioritizing participant safety and data integrity.

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, no additional relevant information about drug administration, dosing schedules, or participant compliance monitoring can be described. The absence of these details limits the ability to provide a comprehensive overview of the treatments involved in the clinical trial.

The clinical trial is in Phase 3 and is scheduled to conclude by December 1, 2025. The recruitment for the trial began on June 20, 2022. 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 protocol to ensure the accurate measurement and analysis of efficacy outcomes. The trial's design and methodology will adhere to rigorous standards typical of Phase 3 trials, focusing on the collection and evaluation of data to determine the treatment's effectiveness. The trial will employ validated tools and instruments to ensure the reliability and validity of the efficacy assessments. The results will contribute to the understanding of the treatment's potential benefits and inform future clinical and regulatory decisions.