Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)



Status:Archived
Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2009
End Date:October 2012

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Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)


This study will evaluate the safety and tolerability of eltrombopag in the treatment of low
platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary
acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or
ineligible to receive azacitidine, decitabine, intensive chemotherapy or
autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in
which patients will receive study medication daily for 6 months, during which time the dose
of study medication may be adjusted based upon individual platelet counts and bone marrow
blast counts. All subjects will receive best standard of care (platelet transfusions, mild
chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition
to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag
treatment if a clinically and statistically significant improvement in bone marrow blast
counts is seen in subjects treated with eltrombopag.


A double-blind, randomized, placebo-controlled phase I/II study to evaluate the safety and
tolerability of eltrombopag olamine, a thrombopoietin receptor agonist, administered for 6
months as oral tablets once daily in adult subjects with advanced MDS, sAML/MDS, or de novo
AML. Study medication may be increased up to 300 mg (150 mg maximum dose for East Asian
subjects), based upon individual platelet counts and bone marrow blast counts.


We found this trial at
11
sites
Anaheim, California 92807
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3400 Spruce St
Philadelphia, Pennsylvania 19104
 (215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Austin, Texas 78705
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Cherry Hill, New Jersey 08003
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Cherry Hill, NJ
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Chesterfield, Missouri 63017
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Grand Rapids, Michigan 49546
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Knoxville, Tennessee 37916
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Knoxville, TN
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1 Medical Center Drive
Morgantown, West Virginia 26506
304-598-4800
West Virginia University Hospitals Inc. WVU Healthcare is two corporations, University Health Associates and WVU...
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Morgantown, WV
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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New Haven, CT
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Philadelphia, Pennsylvania 19104
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Philadelphia, PA
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Richmond, Virginia 23298
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Richmond, VA
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