A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Trial Status: Complete
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.
- 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
- 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.
University of Alabama at Birmingham Cancer Center
UCLA / Jonsson Comprehensive Cancer Center
USC / Norris Comprehensive Cancer Center
University of California San Diego
University of Colorado Hospital
Moffitt Cancer Center
Contact: Jeffrey E. Lancet
Emory University Hospital / Winship Cancer Institute
Contact: Martha Lucia Arellano
University of Chicago Comprehensive Cancer Center
University of Kansas Clinical Research Center
University of Kansas Cancer Center
University of Kansas Hospital-Westwood Cancer Center
Johns Hopkins University / Sidney Kimmel Cancer Center
Dana-Farber Cancer Institute
Massachusetts General Hospital Cancer Center
University of Michigan Comprehensive Cancer Center
Wayne State University / Karmanos Cancer Institute
Siteman Cancer Center at Washington University
Roswell Park Cancer Institute
Case Comprehensive Cancer Center
M D Anderson Cancer Center
Fred Hutch / University of Washington Cancer Consortium
Trial Phase Phase II
Trial Type Treatment
- Primary ID B1371003
- Secondary IDs NCI-2012-01145, 2012-000684-24
- Clinicaltrials.gov ID NCT01546038