Eltrombopag Treatment of Thrombocytopenia in Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)
Public ClinicalTrials.gov record NCT00903422. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00903422
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 98 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 14, 2009 (Actual)
- Primary completion
- Jun 26, 2012 (Actual)
- Completion
- Dec 5, 2013 (Actual)
- Last update posted
- Nov 13, 2017
2009 – 2013
United States locations
- U.S. sites
- 24
- U.S. states
- 16
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Birmingham | Alabama | 35294 | — |
| GSK Investigational Site | Santa Monica | California | 90404 | — |
| GSK Investigational Site | Stanford | California | 94305 | — |
| GSK Investigational Site | Coral Springs | Florida | 33065 | — |
| GSK Investigational Site | Lake Worth | Florida | 33467 | — |
| GSK Investigational Site | Atlanta | Georgia | 30341 | — |
| GSK Investigational Site | Baltimore | Maryland | 21231 | — |
| GSK Investigational Site | Boston | Massachusetts | 02111 | — |
| GSK Investigational Site | Detroit | Michigan | 48202 | — |
| GSK Investigational Site | Kansas City | Missouri | 64128 | — |
| GSK Investigational Site | St Louis | Missouri | 63110 | — |
| GSK Investigational Site | Camden | New Jersey | 08103 | — |
| GSK Investigational Site | The Bronx | New York | 10461 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19104 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19106 | — |
| GSK Investigational Site | Pittsburgh | Pennsylvania | 15224 | — |
| GSK Investigational Site | Greenville | South Carolina | 29601 | — |
| GSK Investigational Site | Memphis | Tennessee | 38120 | — |
| GSK Investigational Site | Houston | Texas | 77030 | — |
| GSK Investigational Site | New Braunfels | Texas | 78130 | — |
| GSK Investigational Site | San Antonio | Texas | 78229 | — |
| GSK Investigational Site | Arlington | Virginia | 22205 | — |
| GSK Investigational Site | Fairfax | Virginia | 22031 | — |
| GSK Investigational Site | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00903422, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 13, 2017 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00903422 live on ClinicalTrials.gov.