Acute Myeloid Leukemia Clinical Trial
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
Summary
This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.
Eligibility Criteria
Inclusion criteria:
Patients must have previously untreated MDS, AML, or CMML according to the WHO 2016 classification.
MDS patients must have Intermediate (>3 to 4.5 points), High Risk (>4.5 - 6) or Very High Risk (>6 points) disease according to the Revised International Prognostic Scoring System 2012 (IPSS-R).
Clinical indication for treatment with azacitidine for MDS or AML.
Exclusion criteria:
Patients with AML who are candidates for standard induction chemotherapy as first line treatment.
Patients with known active CNS leukemia.
Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.
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There are 28 Locations for this study
Birmingham Alabama, 35233, United States
Birmingham Alabama, 35249, United States
La Jolla California, 92093, United States
New Haven Connecticut, 06510, United States
Baltimore Maryland, 21287, United States
Bronx New York, 10461, United States
Bronx New York, 10467, United States
Buffalo New York, 14263, United States
Stony Brook New York, 11794, United States
Stony Brook New York, 11794, United States
Durham North Carolina, 27705, United States
Durham North Carolina, 27710, United States
Durham North Carolina, 27710, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Nashville Tennessee, 37232, United States
Nashville Tennessee, 37232, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84112, United States
Seattle Washington, 98109, United States
Seattle Washington, 98195, United States
Antwerpen , 2060, Belgium
Leuven , 3000, Belgium
Calgary Alberta, T2N 4, Canada
Edmonton Alberta, T6G 2, Canada
Amiens cedex 01 , 80054, France
Paris CEDEX 10 , 75475, France
Pierre Benite Cedex , 69495, France
Tours Cedex 01 , 37044, France
Braunschweig , 38114, Germany
London , SE5 9, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
Oxford , OX3 9, United Kingdom
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