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NCT00854646 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)
A Phase 1 study, sponsored by Traws Pharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT00854646 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 22 participants.
The verdict
NCT00854646, a Phase 1 study, has completed, sponsored by Traws Pharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
This is an open-label, Phase I study to determine the highest amount of the study drug, ON 01910.Na, that can be safety given to patients with high risk myelodysplastic syndromes (MDS) or refractory leukemias. Patients will receive ON 01910.Na (at a starting dose of 650 mg/m2) intravenously by 3-day continuous infusion once every 2 weeks. Successive courses will use longer infusion times and/or higher doses of the drug until toxicity, effectiveness, or ineffectiveness is recognized. In addition, the amount of drug in the blood will be measured, any antitumor activity will be documented, and the biological effect of ON 01910.Na on cell-cycle pathways will be evaluated in peripheral blood mononuclear cells.
Interventions
- DRUG ON 01910.Na
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2008-10 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00854646
The ClinicalTrials.gov registry entry for NCT00854646 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 22 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 ON 01910.Na is the first listed.
NCT00854646 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00854646 about?
NCT00854646 is a clinical study titled "Phase I Study of ON 01910.Na in Refractory Leukemia or Myelodysplastic Syndrome (MDS)". This is an open-label, Phase I study to determine the highest amount of the study drug, ON 01910.Na, that can be safety given to patients with high risk myelodysplastic syndromes (MDS) or refractory leukemias. Patients will receive ON 01910.Na (at a starting dose of 650 mg/m2) intravenously by 3-day...
What is the current status of trial NCT00854646?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2008-10. Estimated completion is 2015-12.
What interventions are being tested in trial NCT00854646?
The interventions under investigation include: ON 01910.Na (DRUG).
Who is sponsoring clinical trial NCT00854646?
This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.
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