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Completed Phase 2 Interventional Results available

A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

ClinicalTrials.gov ID: NCT01546038

Public ClinicalTrials.gov record NCT01546038. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced May 14, 2026, 7:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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 identification

NCT ID
NCT01546038
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Pfizer
Industry
Enrollment
255 participants

Conditions and interventions

Interventions

  • Cytarabine Drug
  • Daunorubicin Drug
  • Decitabine Drug
  • Low dose ARA-C (LDAC) Drug
  • PF-04449913 Drug

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 26, 2012
Primary completion
Jan 2, 2017
Completion
Mar 3, 2019
Last update posted
Mar 2, 2020

2012 – 2019

United States locations

U.S. sites
52
U.S. states
17
U.S. cities
22
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35233
University of Alabama at Birmingham Birmingham Alabama 35249-6909
University of Alabama at Birmingham Birmingham Alabama 35249
UC San Diego Moores Cancer Center - Investigational Drug Services La Jolla California 92037-0845
UC San Diego Medical Center - La Jolla La Jolla California 92037
UC San Diego Moores Cancer Center La Jolla California 92093-0698
Keck Hospital of USC Los Angeles California 90033
LAC & USC Medical Center Los Angeles California 90033
USC/Norris Comprehensive Cancer Center / Investigational Drug Services Los Angeles California 90033
USC/Norris Comprehensive Cancer Center Los Angeles California 90033
Ronald Reagan UCLA Medical Center Drug Information Center Los Angeles California 90095
Ronald Reagan UCLA Medical Center Los Angeles California 90095
UCLA Drug lnformation/lnvestigational Drugs Los Angeles California 90095
UCLA Hematology/Oncology Clinic Los Angeles California 90095
UC San Diego Medical Center - Hillcrest San Diego California 92103
University of Colorado Denver Aurora Colorado 80045
University of Colorado Hospital Aurora Colorado 80045
H.Lee Moffitt Cancer Center and Research Institute Tampa Florida 33612
Emory University Hospital Atlanta Georgia 30322
Investigational Drug Service, Emory University Clinic Atlanta Georgia 30322
The Emory Clinic Atlanta Georgia 30322
Winship Cancer Institute, Emory University Atlanta Georgia 30322
Northwestern Medical Faculty Foundation Chicago Illinois 60611
Northwestern Medicine Developmental Therapeutics Institute Chicago Illinois 60611
Northwestern Memorial Hospital Chicago Illinois 60611
The University of Chicago Medical Center Chicago Illinois 60637
The University of Chicago's Medical Center Chicago Illinois 60637
University of Kansas Clinical Research Center Fairway Kansas 66205
University of Kansas Hospital Kansas City Kansas 66160
University of Kansas Cancer Center and Medical Pavilion Westwood Kansas 66205
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland 21287
Tufts Medical Center Boston Massachusetts 02111
Massachusetts General Hospital Boston Massachusetts 02114
Brigham and Women's Hospital Boston Massachusetts 02115
Dana Farber Cancer Institute (DFCI) Boston Massachusetts 02215
University of Michigan Comprehensive Cancer Center Clinical Trials Office Ann Arbor Michigan 48109-2800
University of Michigan Health System Ann Arbor Michigan 48109
Siteman Cancer Center - West County Creve Coeur Missouri 63141
Barnes Jewish Hospital North Campus St Louis Missouri 63110
Barnes-Jewish Hospital St Louis Missouri 63110
Washington University School of Medicine - Division of Bone Marrow Transplant & Leukemia St Louis Missouri 63110
Washington University School of Medicine, Siteman Cancer Center St Louis Missouri 63110
Hackensack University Medical Center Hackensack New Jersey 07601
John Theurer Cancer Center at Hackensack University Medical Center Hackensack New Jersey 07601
Roswell Park Cancer Institute Buffalo New York 14263
Cleveland Clinic Cancer Institute Cleveland Ohio 44195
Centennial Medical Center Nashville Tennessee 37203
Sarah Cannon Research Institute Nashville Tennessee 37203
Tennessee Oncology, PLLC Nashville Tennessee 37203
The University of Texas, MD Anderson Cancer Center Houston Texas 77030
University of Washington-Seattle Cancer Care Alliance Seattle Washington 98109
University of Washington Medical Center Seattle Washington 98195

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 29 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01546038, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 2, 2020 · Synced May 14, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01546038 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →