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NCT01928537 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine
A Phase 3 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 67
- Enrollment target
NCT01928537: Completed Phase 3 study, sponsored by Traws Pharma.
NCT01928537 is a Phase 3 study that has completed, run by Traws Pharma. The registered enrollment target is 67 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928537, a Phase 3 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 67 participants
- Enrollment target
Study Summary
This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitabine.
Primary Outcome
Bone marrow blast response is defined as bone marrow (BM) complete response, ≥ 50% BM blast decrease from pretreatment value, or stable BM response (no progression) according to the International Working Group (IWG) 2006 criteria and overall survival. Overall survival is defined as the time from first study treatment to death from any cause. All patients will be followed until death and/or progression, even if they have discontinued treatment for whatever cause. Survival time of patients lost to
Interventions
- DRUG rigosertib sodium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-06-29 |
| Phase | Phase 3 |
What the finished NCT01928537 record still lists
NCT01928537 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which rigosertib sodium is the first listed.
NCT01928537 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01928537 about?
NCT01928537 is a clinical study titled "Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine". This study will examine the effect intravenously administered rigosertib has on the relationship between bone marrow blasts response and overall survival in myelodysplastic syndromes (MDS) patients who have 5-30% bone marrow blasts and who progressed on or after treatment with azacitidine or decitab...
What is the current status of trial NCT01928537?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 67 participants. The study started on 2013-08. Estimated completion is 2017-06-29.
What interventions are being tested in trial NCT01928537?
The interventions under investigation include: rigosertib sodium (DRUG).
Who is sponsoring clinical trial NCT01928537?
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 NCT01928537's enrollment target sits among peer trials
67 1796th of 2000 higher than 204 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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