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Brief Title: A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Official Title: A PHASE 1B/2 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-04449913, AN ORAL HEDGEHOG INHIBITOR, IN COMBINATION WITH INTENSIVE CHEMOTHERAPY, LOW DOSE ARA-C OR DECITABINE IN PATIENTS WITH ACUTE MYELOID LEUKEMIA OR HIGH-RISK MYELODYSPLASTIC SYNDROME
Study ID: NCT01546038
Brief Summary: This is a study to evaluate PF-04449913 (an inhibitor of the Hedgehog pathway) in Acute Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents used to treat these diseases.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of Alabama at Birmingham, Birmingham, Alabama, United States
UC San Diego Moores Cancer Center - Investigational Drug Services, La Jolla, California, United States
UC San Diego Medical Center - La Jolla, La Jolla, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
Keck Hospital of USC, Los Angeles, California, United States
LAC & USC Medical Center, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center / Investigational Drug Services, Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center Drug Information Center, Los Angeles, California, United States
Ronald Reagan UCLA Medical Center, Los Angeles, California, United States
UCLA Drug lnformation/lnvestigational Drugs, Los Angeles, California, United States
UCLA Hematology/Oncology Clinic, Los Angeles, California, United States
UC San Diego Medical Center - Hillcrest, San Diego, California, United States
University of Colorado Denver, Aurora, Colorado, United States
University of Colorado Hospital, Aurora, Colorado, United States
H.Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Emory University Hospital, Atlanta, Georgia, United States
Investigational Drug Service, Emory University Clinic, Atlanta, Georgia, United States
The Emory Clinic, Atlanta, Georgia, United States
Winship Cancer Institute, Emory University, Atlanta, Georgia, United States
Northwestern Medical Faculty Foundation, Chicago, Illinois, United States
Northwestern Medicine Developmental Therapeutics Institute, Chicago, Illinois, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
The University of Chicago Medical Center, Chicago, Illinois, United States
The University of Chicago's Medical Center, Chicago, Illinois, United States
University of Kansas Clinical Research Center, Fairway, Kansas, United States
University of Kansas Hospital, Kansas City, Kansas, United States
University of Kansas Cancer Center and Medical Pavilion, Westwood, Kansas, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Brigham and Women's Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute (DFCI), Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Clinical Trials Office, Ann Arbor, Michigan, United States
University of Michigan Health System, Ann Arbor, Michigan, United States
Siteman Cancer Center - West County, Creve Coeur, Missouri, United States
Barnes Jewish Hospital North Campus, Saint Louis, Missouri, United States
Barnes-Jewish Hospital, Saint Louis, Missouri, United States
Washington University School of Medicine - Division of Bone Marrow Transplant & Leukemia, Saint Louis, Missouri, United States
Washington University School of Medicine, Siteman Cancer Center, Saint Louis, Missouri, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Cleveland Clinic Cancer Institute, Cleveland, Ohio, United States
Centennial Medical Center, Nashville, Tennessee, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
The University of Texas, MD Anderson Cancer Center, Houston, Texas, United States
University of Washington-Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Washington Medical Center, Seattle, Washington, United States
Juravinski Cancer Centre @ Hamilton Health Sciences, Hamilton, Ontario, Canada
Centre de Sante et de Services Sociaux (CSSS) Champlain - Charles-Le Moyne, Greenfield Park, Quebec, Canada
Universitaetsklinikum Ulm, Ulm, Baden-wuerttemberg, Germany
Johann Wolfgang Goethe University, Frankfurt am Main, Hessen, Germany
Medizinische Hochschule Hannover, Hannover, Lower Saxony, Germany
Charite -Universitatsmedizin Berlin - Campus Benjamin Franklin, Berlin, , Germany
Charite - Universitatsmedizin Berlin, Berlin, , Germany
Universitaetsklinikum Hamburg-Eppendorf, Hamburg, , Germany
Universitaetsklinikum Schleswig-Holstein, Kiel, , Germany
Universitaetsklinikum Magdeburg A.oe.R., Magdeburg, , Germany
Johannes Gutenberg-Universitaet Mainz, Mainz, , Germany
Universitaetsklinikum Muenster, Muenster, , Germany
Universitaetsklinikum Ulm, Ulm, , Germany
Policlinico S. Orsola-Malpighi, Bologna, Province OF Bologna, Italy
ASST Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Policlinico Universitario "Umberto I" Universita degli Studi "La Sapienza" Sezione di Ematologia, Rome, , Italy
A.O. Citta della Salute e della Scienza di Torino - S.C. Ematologia, Torino, , Italy
Azienda Sanitaria Universitaria Integrata di Udine, Udine, , Italy
Uniwersyteckie Centrum Kliniczne Gdanskiego Uniwersytetu Medycznego, Gdansk, Pomorskie, Poland
Oddzial Hematologii Z pododzialem chemioterapii-Klinika Hematologii Wojewodzkie Wielospecjalistyczne, Lodz, , Poland
Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku, Wroclaw, , Poland
Hospital Universitario Virgen del Rocio, Sevilla, Andalucia, Spain
Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital del Mar, Barcelona, , Spain
Hospital de la Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital Ramon y Cajal, Madrid, , Spain
Hospital Universitario y Politecnico La Fe, Valencia, , Spain
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR