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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 is a Phase 2 study that has completed, run by Traws Pharma. The registered enrollment target is 82 participants.
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.
Interventions
- DRUG rigosertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01584531
The ClinicalTrials.gov registry entry for NCT01584531 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 82 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 rigosertib is the first listed.
NCT01584531 reports 0 study locations.
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.
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