A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
NCT ID: NCT02367456
Last Updated: 2024-01-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
73 participants
INTERVENTIONAL
2015-04-28
2022-03-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
MDS patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2
PF-04449913 (Glasdegib)
Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles
Azacitidine
75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle
Arm B
AML patients: PF-04449913 (Glasdegib) 100 mg + Azacitidine 75 mg/m2
PF-04449913 (Glasdegib)
Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles
Azacitidine
75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle
Interventions
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PF-04449913 (Glasdegib)
Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles
Azacitidine
75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle
Eligibility Criteria
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Inclusion Criteria
* 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 known active CNS leukemia.
* Prior treatment with a smoothened inhibitor (SMOi) and/or hypomethylating agent.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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University of Alabama at Birmingham the Kirklin Clinic
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
UC San Diego Moores Cancer Center
La Jolla, California, United States
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
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
The Newcastle Hospitals NHS Foundation Trust
Newcastle upon Tyne, , United Kingdom
Oxford University Hospitals NHS Foundation Trust
Oxford, , United Kingdom
Countries
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References
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Sekeres MA, Schuster M, Joris M, Krauter J, Maertens J, Breems D, Gyan E, Kovacsovics T, Verma A, Vyas P, Wang ES, Ching K, O'Brien T, Gallo Stampino C, Ma WW, Kudla A, Chan G, Zeidan AM. A phase 1b study of glasdegib + azacitidine in patients with untreated acute myeloid leukemia and higher-risk myelodysplastic syndromes. Ann Hematol. 2022 Aug;101(8):1689-1701. doi: 10.1007/s00277-022-04853-4. Epub 2022 Apr 30.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-001345-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BRIGHT MDS&AML1012
Identifier Type: OTHER
Identifier Source: secondary_id
B1371012
Identifier Type: -
Identifier Source: org_study_id
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