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

Phase 1 Completed 75 enrolled Sunesis Pharmaceuticals

Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start: 2005-11-14
Primary completion: 2008-12-23
Completion: 2009-04

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vosaroxin	Small molecule	9 mg/m2	Intravenous
Subject	Vosaroxin	Small molecule	18 mg/m2	Intravenous

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

Summary

Timeline

Drugs

Indications