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COMPLETED Phase 1

Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies

NCT00246662 · View on ClinicalTrials.gov ↗

Study Summary

This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activity.

Interventions

  • DRUG Vosaroxin

Study Locations (5)

Florida

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

Indiana

  • Indiana University Cancer Center — Indianapolis

Maryland

  • Johns Hopkins Hospital — Baltimore

New Mexico

  • New Mexico Cancer Care Alliance — Albuquerque

Texas

  • University of Texas, MD Anderson Cancer Center — Houston

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2005-11-14
Est. Completion 2009-04
Phase Phase 1

Sponsor

Sunesis Pharmaceuticals

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00246662

The ClinicalTrials.gov registry entry for NCT00246662 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 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sunesis Pharmaceuticals, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Myelodysplastic Syndromes appearing as the primary indexed condition, and to 1 intervention — of which Vosaroxin 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: NCT00246662 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Florida, Indiana, Maryland. 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 NCT00246662 about?

NCT00246662 is a clinical study titled "Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies". This study primarily determined the safety and tolerability of escalating doses of vosaroxin (SNS-595) in 2 dose schedules, and assessed the PK profile of vosaroxin and defined a recommended dose regimen for Phase 2 studies. Secondarily the study assessed potential biomarkers and antileukemic activi...

What is the current status of trial NCT00246662?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2005-11-14. Estimated completion is 2009-04.

What conditions does trial NCT00246662 study?

This clinical trial studies the following conditions: Myelodysplastic Syndromes, Leukemia, Lymphocytic, Acute, Leukemia, Myeloid, Chronic, Leukemia, Nonlymphocytic, Acute. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00246662?

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

Who is sponsoring clinical trial NCT00246662?

This trial is sponsored by Sunesis Pharmaceuticals, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00246662 being conducted?

This trial has 5 study locations across Florida, Indiana, Maryland, New Mexico, Texas. 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