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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: Completed Phase 3 study, sponsored by Traws Pharma.
NCT01241500 is a Phase 3 study that has completed, run by Traws Pharma. The registered enrollment target is 299 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Overall survival (OS) is defined as the time from randomization to death from any cause. All patients will be followed until death or progression, even if they have discontinued treatment for whatever cause. Patients lost to follow-up will be censored at the time last known alive. The OS primary analysis will compare the active ON 01910.Na regimen to BSC once a total number of 223 deaths has been reached.
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 |
What the finished NCT01241500 record still lists
NCT01241500 is an interventional study that assigns participants to a tested intervention. The registered 299 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 1 intervention - of which ON 01910.Na is the first listed.
NCT01241500 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01241500's enrollment target sits among peer trials
299 1161st of 2000 higher than 839 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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