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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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
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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1720 2nd Ave S
Birmingham, Alabama 35233
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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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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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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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666 Elm Street
Buffalo, New York 14263
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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2010 East 90th Street
Cleveland, Ohio 44195
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Durham, North Carolina 27710
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Durham, North Carolina 27710
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Jette, Brussels
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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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La Jolla, California 92093
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Nashville, Tennessee 37232
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Nashville, Tennessee 37232
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35 Park Street
New Haven, Connecticut 06510
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New Haven, Connecticut 06520
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Salt Lake City, Utah 84112
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825 Eastlake Avenue East
Seattle, Washington 98109
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Stony Brook, New York 11794
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