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

Complete title: A Phase 1b Study to Evaluate the Safety and Preliminary 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 (WIRB 20120285, Study 1132239)

Research Study Number       2592.00
    
Principal Investigator       Vivian Oehler, MD
    
Phase       I/II

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Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation.

- Patients in whom, at the time of study entry, a stem cell transplant is planned within the next 6 months.

- Patients with known active uncontrolled central nervous system (CNS) leukemia.

Other exclusion criteria may apply.



Research Study Number       2592.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
    

Keywords
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia

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