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NCT01048619 · ClinicalTrials.gov registry record · Phase 1

Safety and Pharmacokinetic Study of Oral ON 01910.Na in Patients With Myelodysplastic Syndrome

A Phase 1 study of Myelodysplastic Syndrome, sponsored by Traws Pharma.

Completed
Registry status
Phase 1
Development phase
36
Enrollment target
2
Study locations

NCT01048619: Completed Phase 1 study of Myelodysplastic Syndrome, sponsored by Traws Pharma.

NCT01048619 is a Phase 1 study of Myelodysplastic Syndrome that has completed, run by Traws Pharma. The registered enrollment target is 36 participants, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01048619, a Phase 1 study of Myelodysplastic Syndrome, has completed, sponsored by Traws Pharma.

COMPLETED
Registry status
Phase 1
Development phase
36 participants
Enrollment target
2
Study locations

Study Summary

In other clinical studies, ON 01910.Na has been safely given intravenously to Patients with advanced cancers. However, to treat some Patients, it may be better if ON 01910.Na could be given by mouth. This study will determine if it is safe to give ON 01910.Na by mouth, what is the highest dose can be safely given by mouth, and how much of the drug gets from the stomach into the blood stream when it is given by mouth.

Conditions Studied

Interventions

  • DRUG ON 01910.Na

Study Locations (2)

Florida

  • H. Lee Moffitt Cancer Center & Research Institute - Tampa

New York

  • Columbia University Medical Center - New York

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2009-12
Est. Completion 2015-12
Phase Phase 1
Traws Pharma

25 total trials

What the finished NCT01048619 record still lists

NCT01048619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (83% 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.

NCT01048619 reports a single indexed study location in Florida, New York.

Frequently Asked Questions

What is clinical trial NCT01048619 about?

NCT01048619 is a clinical study titled "Safety and Pharmacokinetic Study of Oral ON 01910.Na in Patients With Myelodysplastic Syndrome". In other clinical studies, ON 01910.Na has been safely given intravenously to Patients with advanced cancers. However, to treat some Patients, it may be better if ON 01910.Na could be given by mouth. This study will determine if it is safe to give ON 01910.Na by mouth, what is the highest dose can b...

What is the current status of trial NCT01048619?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2009-12. Estimated completion is 2015-12.

What conditions does trial NCT01048619 study?

This clinical trial studies the following conditions: Myelodysplastic Syndrome.

What interventions are being tested in trial NCT01048619?

The interventions under investigation include: ON 01910.Na (DRUG).

Who is sponsoring clinical trial NCT01048619?

This trial is sponsored by Traws Pharma, which has 25 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01048619 being conducted?

This trial has 2 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Myelodysplastic Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01048619's enrollment target sits among peer trials

36 82nd of 134 higher than 51 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01048619, the US trial registry maintained by the National Library of Medicine. NCT01048619 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.