An Open-label Phase 1b Study Of Pf-04449913 (Glasdegib) In Combination With Azacitidine In Patients With Previously Untreated Higher-risk Myelodysplastic Syndrome, Acute Myeloid Leukemia, Or Chronic Myelomonocytic Leukemia

What is the purpose of this trial?

This multi center randomized (1:1), double blind, placebo controlled Phase 1b/2 study is designed to compare the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of PF 04449913 or placebo when combined with azacitidine in patients with previously untreated Intermediate 2 or High Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) with 20-30% blasts and multi lineage dysplasia, and Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a Phase 1b safety lead in and (b) a randomized Phase 2.

Pfizer Inc., U.S. Pharmaceuticals Group

Start Date: 05/11/2015

End Date: 11/07/2019

Last Updated: 02/22/2018

Study HIC#: 1410014839