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

The primary objective of this study is to evaluate the **pharmacokinetics** (PK) and safety of oral decitabine and cedazuridine in patients with **acute myeloid leukemia** (AML), **myelodysplastic syndrome** (MDS), or solid tumors who have renal impairment. Understanding the PK profile and safety in this specific patient population is clinically relevant as it may inform dosing adjustments and safety monitoring, ensuring effective and safe treatment for patients with compromised renal function.

The clinical trial involves a total of **5 participants** diagnosed with **acute myeloid leukemia (AML)**, **myelodysplastic syndrome (MDS)**, or solid tumors. The study population includes both male and female subjects, with an age range spanning from 18 to 65 years. Participants were selected without targeting any vulnerable populations. The trial does not specify any particular lifestyle considerations such as diet or physical activity. The sponsor has not provided detailed information regarding the principal inclusion or exclusion criteria for this study.

The clinical trial is designed to evaluate the pharmacokinetics and safety of oral **decitabine** and **cedazuridine** in patients with **acute myeloid leukemia (AML)**, **myelodysplastic syndrome (MDS)**, or solid tumors who have renal impairment. This study is a Phase 3, randomized, double-blind, controlled trial, with an estimated recruitment start date of November 30, 2021, and an anticipated end date of December 1, 2025. The trial will involve multiple study visits, beginning with an inclusion (screening) visit to assess eligibility based on predefined criteria. Participants will undergo regular follow-up visits to monitor drug efficacy and safety, as well as to collect pharmacokinetic data. The end-of-study visit will conclude the trial, where final assessments will be conducted to evaluate the overall outcomes.

The expected duration of participant involvement in the trial will vary depending on individual response and tolerance to the treatment, but it is anticipated to last until the end of the study period. Conditions that may lead to early termination from the study include adverse reactions to the study drugs, withdrawal of consent, or any significant protocol deviations. Participants will be closely monitored throughout the trial to ensure their safety and the integrity of the study data. The trial aims to provide valuable insights into the treatment of patients with renal impairment suffering from AML, MDS, or solid tumors, contributing to the advancement of therapeutic strategies in these conditions.

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. Consequently, additional relevant information about drug administration, dosing schedules, and participant compliance monitoring is also not included. The absence of this data precludes a comprehensive description of the treatments used in the study.

The clinical trial is designed to assess efficacy through a structured evaluation process. The trial is categorized as a Phase 3 study, indicating it is in the advanced stages of clinical research. The estimated recruitment start date was November 30, 2021, with an anticipated end date of December 1, 2025. Although specific primary and secondary endpoints are not detailed, Phase 3 trials typically focus on confirming the effectiveness of a treatment, monitoring side effects, and collecting information that will allow the treatment to be used safely. The efficacy assessment will likely involve a combination of clinical evaluations, laboratory tests, and possibly patient-reported outcomes, measured at various timepoints throughout the trial duration. The data collected will be analyzed to determine the treatment's impact on the disease, with the goal of establishing a clear benefit-risk profile. The trial's findings will contribute to the understanding of the treatment's efficacy in the target population.