A Study To Evaluate PF-04449913 With Chemotherapy In Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome
Status: | Active, not recruiting |
---|---|
Conditions: | Blood Cancer, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/13/2019 |
Start Date: | June 27, 2012 |
End Date: | March 4, 2019 |
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
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.
Myeloid Leukemia and high-risk Myelodysplastic Syndrome in combination with standard agents
used to treat these diseases.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
We found this trial at
52
sites
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Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Roswell Park Cancer Institute Welcome to Roswell Park Cancer Institute (RPCI), America's first cancer center...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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University of Colorado Hospital, Site Top medical professionals, superior medicine and progressive change make University...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Hackensack University Medical Center Hackensack University Medical Center, part of the Hackensack University Health Network,...
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92 2nd St
Hackensack, New Jersey 07601
Hackensack, New Jersey 07601
(201) 996-5900
John Theurer Cancer Center at the Hackensack University Medical Center The mission of the John...
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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3855 Health Sciences Dr,
La Jolla, California 92093
La Jolla, California 92093
(858) 822-6100
UC San Diego Moores Cancer Center Established in 1978, UC San Diego Moores Cancer Center...
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1441 Eastlake Ave
Los Angeles, California 90033
Los Angeles, California 90033
(323) 865-3000
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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3322 West End Avenue
Nashville, Tennessee 37203
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Saint Louis, Missouri 63110
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University of Washington Medical Center University of Washington Medical Center is one of the nation's...
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