|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | GlaxoSmithKline |
|---|---|
| Information provided by: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT00903422 |
Purpose
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) or secondary acute myeloid leukemia after MDS (sAML/MDS) 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Advanced Myelodysplastic Syndrome Myelodysplastic Syndrome Secondary Acute Myeloid Leukemia After MDS Thrombocytopenia |
Drug: eltrombopag olamine Other: Placebo |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment, Safety Study |
| Official Title: | 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) |
| Estimated Enrollment: | 90 |
| Study Start Date: | May 2009 |
| Estimated Study Completion Date: | December 2011 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Eltrombopag: Active Comparator |
Drug: eltrombopag olamine
thrombopoietin receptor agonist
|
| Placebo: Placebo Comparator |
Other: Placebo
Placebo tablets with no active pharmaceutical ingredient
|
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 MDS or sAML/MDS. 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
| United States, California | |
| GSK Investigational Site | Not yet recruiting |
| Stanford, California, United States, 94305 | |
| Principal Investigator: Peter Greenberg | |
| United States, Massachusetts | |
| GSK Investigational Site | Not yet recruiting |
| Boston, Massachusetts, United States, 02111 | |
| Principal Investigator: Kenneth B Miller | |
| United States, Missouri | |
| GSK Investigational Site | Recruiting |
| Kansas City, Missouri, United States, 64128 | |
| Principal Investigator: Suman Kambhampati | |
| United States, Pennsylvania | |
| GSK Investigational Site | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Principal Investigator: Noelle Frey | |
| GSK Investigational Site | Not yet recruiting |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Principal Investigator: Ingrid F Kohut | |
| United States, Tennessee | |
| GSK Investigational Site | Not yet recruiting |
| Memphis, Tennessee, United States, 38120 | |
| Principal Investigator: Bradley G Somer | |
| United States, Texas | |
| GSK Investigational Site | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| Principal Investigator: Roger M Lyons | |
| GSK Investigational Site | Not yet recruiting |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: Hagop Kantarjian | |
| GSK Investigational Site | Not yet recruiting |
| New Braunfels, Texas, United States, 78130 | |
| Principal Investigator: Roger M Lyons | |
| Germany, Nordrhein-Westfalen | |
| GSK Investigational Site | Not yet recruiting |
| Duisburg, Nordrhein-Westfalen, Germany, 47166 | |
| Principal Investigator: Aristoteles Giagounidis | |
| Hong Kong | |
| GSK Investigational Site | Recruiting |
| Shatin, New Territories, Hong Kong | |
| Principal Investigator: Gregory Cheng | |
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
| Responsible Party: | GSK ( Study Director ) |
| Study ID Numbers: | 112509 |
| Study First Received: | May 14, 2009 |
| Last Updated: | December 17, 2009 |
| ClinicalTrials.gov Identifier: | NCT00903422 History of Changes |
| Health Authority: | Hong Kong: Department of Health; United States: Food and Drug Administration |
|
Thrombopoietin Platelets MDS sAML/MDS |
Eltrombopag Thrombopoietin receptor agonist TPO-R agonist |
|
Disease Neoplasms by Histologic Type Precancerous Conditions Hematologic Diseases Blood Platelet Disorders Myelodysplastic Syndromes Leukemia, Myeloid Leukemia, Myeloid, Acute Leukemia |
Neoplastic Processes Preleukemia Neoplasms Pathologic Processes Thrombocytopenia Syndrome Neoplasm Metastasis Bone Marrow Diseases |