Phase I Study Evaluating Safety and Effectiveness of STI-8591 for Adults with Advanced Acute Myeloid Leukemia

What this Trial Is About

Researchers are evaluating the safety, tolerability, how the body processes the drug, and preliminary effectiveness of STI-8591 in adults with advanced acute myeloid leukemia AML or related myelodysplastic conditions who have failed or cannot tolerate standard treatments. This Phase I study focuses on finding the right dose and understanding the potential effects of STI-8591 in this serious blood cancer. The study includes a dose escalation phase to identify safe dosage levels and a dose expansion phase to further assess safety and early treatment responses. During the dose escalation phase, participants receive STI-8591 in increasing doses starting from 40 mg up to 280 mg per day using a rapid titration and traditional 33 design. The medication is taken twice daily in 28-day cycles, with specific fasting and dosing intervals. If preliminary signs of effectiveness appear, the dose expansion phase begins for selected dose groups, enrolling additional participants to better define the recommended dose for further studies. Dosing schedules and adjustments are based on ongoing safety and response data. Participants will undergo regular assessments including blood tests, bone marrow biopsies, and monitoring for side effects over the study period. Researchers will measure adverse events, drug levels in the body, effects on leukemia markers such as FLT3 plasma inhibitory activity, and various remission and survival outcomes up to about two years. The study includes careful safety monitoring and follow-up for up to three years to understand treatment effects and tolerability.

A Study to Evaluate the STI-8591 in Subjects With Advanced Acute Myeloid Leukemia (AML)