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NCT00906334 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of ON 01910.Na in Myelodysplastic Syndrome (MDS) Patients With Trisomy 8 or Classified as Intermediate-1, -2 or High Risk
A Phase 2 study of Myelodysplastic Syndrome, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT00906334: Completed Phase 2 study of Myelodysplastic Syndrome, sponsored by Traws Pharma.
NCT00906334 is a Phase 2 study of Myelodysplastic Syndrome that has completed, run by Traws Pharma. The registered enrollment target is 14 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00906334, a Phase 2 study of Myelodysplastic Syndrome, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will explore the efficacy and safety of a regimen of ON 01910.Na as a 48-hour continuous intravenous infusion once a week for 3 weeks of a 4-week cycle in MDS patients with Trisomy 8 or classified as Intermediate-1, -2 or High Risk who are not responding to current therapeutic options. The rationale for this trial is based upon data from laboratory studies with ON 01910.Na and upon activity that has been observed in other clinical trials with ON 01910.Na in patients with MDS.
Primary Outcome
The Overall Response Rate is defined as the proportion of patients who achieve a Complete Response, a Partial Response, A Complete Bone Marrow Response or a Hematologic Improvement (HI) according to the 2006 International Working Group (IWG) criteria.
Conditions Studied
Interventions
- DRUG ON 01910.Na
Study Locations (1)
California
- Stanford Cancer Center - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2009-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT00906334 record still lists
NCT00906334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Myelodysplastic Syndrome appearing as the primary indexed condition, and to 1 intervention - of which ON 01910.Na is the first listed.
NCT00906334 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00906334 about?
NCT00906334 is a clinical study titled "Efficacy and Safety of ON 01910.Na in Myelodysplastic Syndrome (MDS) Patients With Trisomy 8 or Classified as Intermediate-1, -2 or High Risk". This study will explore the efficacy and safety of a regimen of ON 01910.Na as a 48-hour continuous intravenous infusion once a week for 3 weeks of a 4-week cycle in MDS patients with Trisomy 8 or classified as Intermediate-1, -2 or High Risk who are not responding to current therapeutic options. Th...
What is the current status of trial NCT00906334?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2009-05. Estimated completion is 2013-11.
What conditions does trial NCT00906334 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome.
What interventions are being tested in trial NCT00906334?
The interventions under investigation include: ON 01910.Na (DRUG).
Who is sponsoring clinical trial NCT00906334?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00906334 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00906334's enrollment target sits among peer trials
14 124th of 134 higher than 9 of 134 other Myelodysplastic Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome 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.
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