A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
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.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01546038
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 255 participants
Conditions and interventions
Conditions
Interventions
- PF-04449913 Drug
- Low dose ARA-C (LDAC) Drug
- Decitabine Drug
- Daunorubicin Drug
- Cytarabine 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 27, 2012 (Actual)
- Primary completion
- Jan 3, 2017 (Actual)
- Completion
- Mar 4, 2019 (Actual)
- Last update posted
- Mar 3, 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 3, 2020 · Synced Oct 21, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01546038 live on ClinicalTrials.gov.