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

Completed · Phase 1

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

In brief

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.

Key facts

Study ID

NCT02367456

Run by

Pfizer

People needed

73

Starts

2015-04-28

Expected to finish

2022-03-07

Last updated by the study team

2024-01-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Stony Brook University Hospital Cancer Center — Stony Brook, New York, United States
• Stony Brook University — Stony Brook, New York, United States
• Montefiore Einstein Center for Cancer — The Bronx, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Health System: Adult Bone Marrow Transplant Clinic — Durham, North Carolina, United States
• Duke University Health System, Duke University Hospital — Durham, North Carolina, United States
• Duke University Health System — Durham, North Carolina, United States
• Investigational Chemotherapy Service — Durham, North Carolina, United States
• Cleveland Clinic Taussig Cancer Center — Cleveland, Ohio, United States
• Henry-Joyce Cancer Center — Nashville, Tennessee, United States
• Vanderbilt - Ingram Cancer Center — Nashville, Tennessee, United States
• Huntsman Cancer Hospital — Salt Lake City, Utah, United States
• Huntsman Cancer Institute — Salt Lake City, Utah, United States
• Seattle Cancer Care Alliance (SCCA) — Seattle, Washington, United States
• University of Washington Medical Center (UWMC) — Seattle, Washington, United States
• Ziekenhuis Netwerk Antwerpen - Campus Stuivenberg — Antwerp, Belgium
• UZ Leuven — Leuven, Belgium
• Tom Baker Cancer Center — Calgary, Alberta, Canada
• University Of Alberta Hospital — Edmonton, Alberta, Canada
• CHU d'Amiens-Picardie - Hopital SUD — Amiens, France
• Hopital Saint-Louis (AP-HP) - Service Hematologie Senior — Paris, France
• Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie — Pierre-Bénite, France
• CHU de Tours-Hopital Bretonneau-Centre Regional de cancerologie Henry Kaplan — Tours, France
• Staedtisches Klinikum Braunschweig gGmbH — Braunschweig, Germany
• King's College Hospital — London, United Kingdom

Full record on ClinicalTrials.gov

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