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



Status:Recruiting
Conditions:Cancer, Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - Any
Updated:3/8/2019
Start Date:April 28, 2015
End Date:February 26, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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Trial Summary
Trial Overview
Inclusion Criteria

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

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.


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.
We found this trial at
26
sites
Smilow Cancer Center at Yale New Haven Hospital
New Haven, Connecticut 06510
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland 21231
410-955-6190
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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University of Alabama at Birmingham
1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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Montefiore Medical Center
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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Roswell Park Cancer Institute
666 Elm Street
Buffalo, New York 14263
(716) 845-2300
Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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Buffalo, NY
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University of Alabama at Birmingham, The Kirklin Clinic
Birmingham, Alabama 35233
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Birmingham, AL
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Montefiore Einstein Center for Cancer
Bronx, New York 10461
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Bronx, NY
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Cleveland Clinic Taussig Cancer Center Pharmacy
2010 East 90th Street
Cleveland, Ohio 44195
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Cleveland, OH
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The Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio 44195
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Cleveland, OH
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Duke Cancer Center
Durham, North Carolina 27710
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Durham, NC
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Investigational Chemotherapy Service
Durham, North Carolina 27710
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Durham, NC
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UZ Brussel
Jette, Brussels
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Jette,
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UC San Diego Moores Cancer Center
3855 Health Sciences Dr,
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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University of California, San Diego (UCSD)
La Jolla, California 92093
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La Jolla, CA
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Dartmouth Hitchcock Medical Center
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Henry Joyce Cancer Center
Nashville, Tennessee 37232
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Nashville, TN
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Vanderbilt Oncology Pharmacy
Nashville, Tennessee 37232
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Nashville, TN
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Smilow Cancer Center at Yale New Haven Hospital, oncology Pharmacy
35 Park Street
New Haven, Connecticut 06510
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New Haven, CT
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Yale University, Yale Cancer Center
New Haven, Connecticut 06520
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New Haven, CT
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Huntsman Cancer Hospital / University of Utah
Salt Lake City, Utah 84112
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Salt Lake City, UT
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Huntsman Cancer Institute
Salt Lake City, Utah 84112
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Salt Lake City, UT
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Seattle Cancer Care Alliance (SCCA)
825 Eastlake Avenue East
Seattle, Washington 98109
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Seattle, WA
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University of Washington Medical Center (UWMC)
Seattle, Washington 98195
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Stony Brook Medicine
Stony Brook, New York 11794
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Stony Brook, NY
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