Syros Pharmaceuticals: SY-1425-201 Ph2 SY-1425 Tamibarotene AML-MDS - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if the study drug, SY-1425-201, works in treating AML and MDS in patients with, or with out a certain biomarker in their blood.
Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Who Can Participate in the Study?
- Have the biomarker Retinoic Acid Receptor Alpha OR Acute Myeloid Leukemia OR Myelodysplastic Syndrome who:
- Have relapsed and/or refractory AML that has failed to achieve a complete or partial response following standard therapy
- Have relapsed and/or refractory higher risk MDS that has failed to achieve a complete or partial response
- Have new diagnosed AML who are unlikely to tolerate standard intensive chemotherapy
- Have stopped other chemotherapy, radiation therapy, growth factor and other investigational agents at least two weeks before starting study treatment
- Are willing to be tested for the RARA and IRF8 biomarkers
- Do not have an elevated white blood cell count
- Do not have significant heart disease
- Do not have active, uncontrolled infection, HIV, Hepatitis B or C
- Do not have active, uncontrolled central nervous system leukemia
What is Involved?
If you choose to join the study, you will:
- Have a screening visit to make sure it is safe for you to be in the study
During treatment, you will
- Take the study drug, SY-1425-201, by mouth twice a day every day for 28 days
After treatment is finished, you will have follow-up visits that include physical exams and other tests, every three months for up to 2 years.