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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 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.

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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

Sponsor

Traws Pharma

25 total trials

What the Registry Record Tells You About NCT01048619

The ClinicalTrials.gov registry entry for NCT01048619 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 134 other Myelodysplastic Syndrome trials with a reported enrollment target (83% lower). The listed sponsor is Traws Pharma, which has 25 total studies on file at ClinicalTrials.gov.

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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.