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COMPLETED Phase 1

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

NCT01048619 · View on ClinicalTrials.gov ↗

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

8 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01048619

The ClinicalTrials.gov registry entry for NCT01048619 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Traws Pharma, which has 8 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01048619 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Florida, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01048619?

The interventions under investigation include: ON 01910.Na (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01048619?

This trial is sponsored by Traws Pharma, which has 8 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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