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NCT00246662 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Myelodysplastic Syndromes and Leukemia, Lymphocytic, Acute, sponsored by Sunesis Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
75
Enrollment target
5
Study locations

NCT00246662 is a Phase 1 study of Myelodysplastic Syndromes and Leukemia, Lymphocytic, Acute that has completed, run by Sunesis Pharmaceuticals. The registered enrollment target is 75 participants, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (74% lower). The trial reports 5 study locations across 5 states.

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The verdict

NCT00246662, a Phase 1 study of Myelodysplastic Syndromes and Leukemia, Lymphocytic, Acute, has completed, sponsored by Sunesis Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
75 participants
Enrollment target
5
Study locations

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

13 total trials

What the Registry Record Tells You About NCT00246662

The ClinicalTrials.gov registry entry for NCT00246662 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 285-participant average among 173 other Myelodysplastic Syndromes trials with a reported enrollment target (74% lower). The listed sponsor is Sunesis Pharmaceuticals, which has 13 total studies on file at ClinicalTrials.gov.

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.

NCT00246662 reports 5 study locations spanning 5 distinct geographic areas - top geographies include Florida, Indiana, Maryland.

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.

What interventions are being tested in trial NCT00246662?

The interventions under investigation include: Vosaroxin (DRUG).

Who is sponsoring clinical trial NCT00246662?

This trial is sponsored by Sunesis Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.

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.

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

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