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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: Completed Phase 1 study, sponsored by Traws Pharma.

NCT00854646 is a Phase 1 study that has completed, run by Traws Pharma. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 22 participants
Start Date 2008-10
Est. Completion 2015-12
Phase Phase 1
Traws Pharma

25 total trials

What the finished NCT00854646 record still lists

NCT00854646 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).

The record links to 0 conditions, and to 1 intervention - of which ON 01910.Na is the first listed.

NCT00854646 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT00854646's enrollment target sits among peer trials

22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00854646, the US trial registry maintained by the National Library of Medicine. NCT00854646 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.