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

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

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.

Key facts

Study ID

NCT01546038

Run by

Pfizer

People needed

255

Starts

2012-06-27

Expected to finish

2019-03-04

Last updated by the study team

2020-03-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with AML or RAEB 2 High Risk MDS who are newly diagnosed according to the WHO 2008 Classification and previously untreated.
• Patients with AML (arising from an antecedent hematologic disease [AHD]) or MDS who may have had one prior regimen with commercially available agents for the treatment of their prior hematologic disease. The patients may not have had a prior therapy for their AML.
• AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML)
• For a diagnosis of AML, a bone marrow blast count of 20% or more is required.
• For a diagnosis of high-risk Myelodysplastic Syndrome RAEB 2 the patient must have 10-19% bone marrow blasts
• Adequate Organ Function
• ECOG Performance Status 0, 1, or 2

You may not qualify if…

• AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation.
• Patients with known active uncontrolled central nervous system (CNS) leukemia.

Where it is running

• 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
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.