Spots Global Cancer Trial Database for A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
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Trial Identification
Brief Title: A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
Official Title: 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
Study ID: NCT02367456
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Montefiore Einstein Center for Cancer, Bronx, New York, United States
Montefiore Medical Center, Bronx, New York, 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
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, Antwerpen, , 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 cedex 01, , France
Hopital Saint-Louis (AP-HP) - Service Hematologie Senior, Paris CEDEX 10, , France
Hospices Civils de Lyon - Hopital Lyon Sud- Hematologie, Pierre Benite Cedex, , France
CHU de Tours-Hopital Bretonneau-Centre Regional de cancerologie Henry Kaplan, Tours Cedex 01, , 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
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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