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NCT01286038 · ClinicalTrials.gov registry record · Phase 1
Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT01286038: Clinical Trial Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT01286038 is a Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01286038, a Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the safety and efficacy of eltrombopag in people who have myelodysplastic syndrome (MDS) with thrombocytopenia who have progressed or are resistant to decitabine or azacitidine. (These are the only 2 drugs approved by the U.S. Food and Drug Administration \[FDA\] which can improve platelet counts). The investigators (the study doctor, study staff, and sponsor) want to find out what effects, good or bad, eltrombopag (study drug) may have on people with low platelet counts due to MDS. The investigators will also be testing how well eltrombopag may work at different doses in these diseases.
Primary Outcome
Determine the maximum tolerated dose (MTD) of eltrombopag for the treatment of thrombocytopenia in participants with MDS who have either progressed or are resistant to Hypomethylating Agents (HMTA). The MTD is defined as the highest dose where less than 33% of participants experience a drug related predefined dose limited toxicity (DLT).
Interventions
- DRUG Eltrombopag
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2011-04-06 |
| Est. Completion | 2018-11-03 |
| Phase | Phase 1 |
Why NCT01286038 stopped before completion
NCT01286038 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Eltrombopag is the first listed.
NCT01286038 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01286038 about?
NCT01286038 is a clinical study titled "Eltrombopag in Myelodysplastic Syndrome (MDS) Patients With Thrombocytopenia". The purpose of this study is to evaluate the safety and efficacy of eltrombopag in people who have myelodysplastic syndrome (MDS) with thrombocytopenia who have progressed or are resistant to decitabine or azacitidine. (These are the only 2 drugs approved by the U.S. Food and Drug Administration \[F...
What is the current status of trial NCT01286038?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2011-04-06. Estimated completion is 2018-11-03.
What interventions are being tested in trial NCT01286038?
The interventions under investigation include: Eltrombopag (DRUG).
Who is sponsoring clinical trial NCT01286038?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01286038's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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