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A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients

NCT02367456

CompletedPhase 1

Sponsor: Pfizer

Conditions: Myelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia

Interventions: PF-04449913 (Glasdegib), Azacitidine

Countries: United States, Belgium, Canada, France, Germany, United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.
Locations (33)
  • Birmingham, Alabama, United States
  • Birmingham, Alabama, United States
  • La Jolla, California, United States
  • New Haven, Connecticut, United States
  • Baltimore, Maryland, United States
  • Buffalo, New York, United States
  • Stony Brook, New York, United States
  • Stony Brook, New York, United States
  • The Bronx, New York, United States
  • The Bronx, New York, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • Durham, North Carolina, United States
  • Cleveland, Ohio, United States
  • Nashville, Tennessee, United States
  • Nashville, Tennessee, United States
  • Salt Lake City, Utah, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • Seattle, Washington, United States
  • Antwerp, Belgium
  • Leuven, Belgium
  • Calgary, Alberta, Canada
  • Edmonton, Alberta, Canada
  • Amiens, France
  • Paris, France
  • Pierre-Bénite, France
  • Tours, France
  • Braunschweig, Germany
  • + 3 more on CT.gov