A Phase I Study of FLX925 in Patients with Recurrent or Persistent Acute Myeloid Leukemia

Full Title

Phase 1/1b, First-in-Human, Dose-Escalation and Expansion Study of FLX925 Administered Orally to Subjects with Relapsed or Refractory Acute Myeloid Leukemia


The purpose of this study is to find the highest dose of the investigational drug FLX925 that can be given safely in patients with acute myeloid leukemia (AML) that has continued to grow or came back despite prior treatment. FLX925 is designed to inhibit AML growth by interfering with the actions of mutated FLT3, CDK4, and CDK6 genes, which promote leukemia growth.

FLX925 is a tablet that is taken orally (by mouth).


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have recurrent or persistent AML.
  • Patients must recover from the serious side effects of prior therapies before entering the study.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Raajit Rampal at 212-639-2194.