Protocol
12-106
Full Title
A Phase 2, Randomized, Open-Label Study of the Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
Purpose
The purpose of this study is to evaluate the safety and effectiveness of two different doses of an investigational drug called quizartinib (also known as AC220) in patients with acute myeloid leukemia (AML) that has returned or continues to grow despite standard therapies.
Quizartinib is an investigational drug which works by blocking certain targets on cancer cells (enzymes called “receptor tyrosine kinases”). It appears to work best in patients with AML who have mutations in the FLT3-ITD gene, which are found in 20 to 30 percent of AML patients. It is an oral solution that is taken by mouth.
Investigator
Eligibility
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have AML that has returned or continues to grow despite standard therapies.
- Patients’ AML must be positive for the FLT3-ITD genetic mutation.
- Patients must have recovered from the serious side effects of prior therapies.
- Patients must be able to be ambulatory for more than half of their normal waking hours.
- Patients must be age 18 or older.
For more information about this study and to inquire about eligibility, please contact Dr. Martin Tallman at 212-639-3842.
Disease(s)
Leukemia
Leukemia: Acute Myelocytic Leukemia
Leukemia: Acute Myelogenous Leukemia
Locations
Related Diseases
