CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 113 enrolled
Drug / intervention
vosaroxindrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00607997
NCT00607997Phase 2Completed
CompareCT.gov

A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia

Sunesis Pharmaceuticals·interventional·Posted Feb 6, 2008·Updated Jun 28, 2017

In Brief

A Phase 2 clinical trial evaluating vosaroxin for Leukemia and 4 related conditions. Completed, enrolled 113 participants across 20 sites.

Detailed Summary

This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Acute Disease, Acute Myeloid Leukemia, Nonlymphocytic Leukemia, Myelodysplastic Syndromes
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 6, 2008
Enrollment StartMay 15, 2008
Primary CompletionNov 1, 2009
Study CompletionNov 23, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.4 years ago

Interventions

vosaroxindrug

Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.