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NCT01584531 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome
A Phase 2 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
NCT01584531: Completed Phase 2 study, sponsored by Traws Pharma.
NCT01584531 is a Phase 2 study that has completed, run by Traws Pharma. The registered enrollment target is 82 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01584531, a Phase 2 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
Study Summary
The primary objectives of this study are to determine if rigosertib sodium, given orally in the form of soft gel capsules, is safe and is associated with a reduction in the number of blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS) classified as Low or Intermediate-1 (Int-1) (any cytogenetics) or trisomy 8 Intermediate 2 (Int-2) in the International Prognostic Scoring System (IPSS) who are transfusion-dependent. Rigosertib will be taken on days 1 to 21 of a 21-day cycle.
Primary Outcome
Number of units of red blood cell transfusions will be compared with the pretreatment transfusion number in the previous 8 weeks.
Interventions
- DRUG rigosertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
What the finished NCT01584531 record still lists
NCT01584531 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which rigosertib is the first listed.
NCT01584531 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01584531 about?
NCT01584531 is a clinical study titled "Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome". The primary objectives of this study are to determine if rigosertib sodium, given orally in the form of soft gel capsules, is safe and is associated with a reduction in the number of blood transfusion units that are needed in patients with myelodysplastic syndrome (MDS) classified as Low or Intermed...
What is the current status of trial NCT01584531?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2012-05. Estimated completion is 2015-11.
What interventions are being tested in trial NCT01584531?
The interventions under investigation include: rigosertib (DRUG).
Who is sponsoring clinical trial NCT01584531?
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 NCT01584531's enrollment target sits among peer trials
82 830th of 2000 higher than 1,167 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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