drugset / Trial / NCT02129101

Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies

NCT02129101

NaSingle-groupOpen-labelTreatment

Summary

This phase I/Ib trial studies the side effects and best dose of azacitidine and sonidegib or decitabine and so see how well they work in treating patients with myeloid malignancies. The hedgehog (Hh) signaling pathway plays an important role in cellular growth, differentiation and repair. Inappropriate activation of Hh pathway signaling and uncontrolled cellular proliferation may be associated with mutations in the Hh-ligand cell surface receptor Smo. Sonidegib binds to the Hh cell surface receptor Smo, which may result in the suppression of the Hh signaling pathway and the inhibition of cancer cells. Azacitidine and decitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with sonidegib or decitabine may be a safe and successful treatment for patients with myeloid malignancies.

Timeline

Start
2014-05
Primary completion
2016-12-31
Completion
2019-10-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Azacitidine Other / unclassified Subcutaneous
Subject Decitabine Small molecule Intravenous
Subject Sonidegib Small molecule Oral