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.

What is the Condition Being Studied?

Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Who Can Participate in the Study?

Adults who
- 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

Age Group

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.

Study Details

Full Title
A Biomarker-Directed Phase 2 Trial of SY-1425, a Selective Retinoic Acid Receptor Alpha Agonist, in Adult Patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)
Principal Investigator
Cell Therapy and Hematologic Malignancies Specialist
Protocol Number
IRB: PRO00072859
NCT: NCT02807558
Phase II
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center