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A drug, selumetinib, in combination with azacitidine to treat myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms (MDS/MPN), or myelofibrosis that has come back (relapsed) or did not get better with treatment (refractory)

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18 and older

Phase 1

1 Location

NCT03326310

Clinical Trial Goal


To find out:
  • The highest dose of selumetinib that’s safe to give with azacitidine
  • If the combination of selumetinib and azacitidine is safe and works well to treat MDS, MDS/MPN, or myelofibrosis

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have one of the following diseases that has relapsed or is refractory:
    • Atypical chronic myeloid leukemia (aCML)
    • Chronic myelomonocytic leukemia (CMML)
    • MDS
    • MDS/MPN unclassifiable
    • Post-essential thrombocythemia myelofibrosis
    • Post-polycythemia vera myelofibrosis
    • Primary myelofibrosis
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


Azacitidine is a drug that blocks growth of cancer cells.
Selumetinib is a small molecule inhibitor that blocks MEK1/2 in certain cells.

You’ll get:
  • Azacitidine – Given as a shot under the skin 1 time each day for the first week of each month 
  • Selumetinib – A pill that you take by mouth each day during the second and third week of each month. The dose you'll get depends on when you start the trial and how safe it has been

You may continue treatment for as long as the clinical trial doctors think it’s best for your health. You’ll have biopsies to see how well treatment is working. After you finish treatment, the clinical trial doctors will check your health for up to 4 months.

The Food and Drug Administration (FDA) has approved azacitidine to treat MDS. The FDA has not yet approved selumetinib. 

Contacts


Cancer Clinical Trials Office, 1-855-702-8222, cancerclinicaltrials@bsd.uchicago.edu

Olatoyosi Odenike, MD, 7737023354, todenike@medicine.bsd.uchicago.edu

Locations


The University of ChicagoRECRUITING

Chicago, Illinois
Melissa Fridstein, 773-702-9885, mfridstein@medicine.bsd.uchicago.edu

ClinicalTrials.gov record


NCT03326310. First posted on 10/31/17

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