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NCT01241500 · ClinicalTrials.gov registry record · Phase 3
Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts
A Phase 3 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 299
- Enrollment target
NCT01241500 is a Phase 3 study that has completed, run by Traws Pharma. The registered enrollment target is 299 participants.
The verdict
NCT01241500, a Phase 3 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 299 participants
- Enrollment target
Study Summary
The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient population has no available therapy and a short life expectancy (approximately 4 months). The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies has the potential to delay substantially the transition of MDS to Acute Myeloid Leukemia(AML), a very significant and severe complication, which shortens survival of these MDS patients.
Interventions
- DRUG ON 01910.Na
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 299 participants |
| Start Date | 2010-11 |
| Est. Completion | 2018-10-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01241500
The ClinicalTrials.gov registry entry for NCT01241500 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 299 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Traws Pharma, which has 25 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ON 01910.Na is the first listed.
NCT01241500 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01241500 about?
NCT01241500 is a clinical study titled "Randomized Study of ON 01910.Na in Refractory Myelodysplastic Syndrome Patients With Excess Blasts". The primary objective of this study is to compare overall survival (OS) in patients receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30% bone marrow blasts) who have failed aza...
What is the current status of trial NCT01241500?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 299 participants. The study started on 2010-11. Estimated completion is 2018-10-03.
What interventions are being tested in trial NCT01241500?
The interventions under investigation include: ON 01910.Na (DRUG).
Who is sponsoring clinical trial NCT01241500?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
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