Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246662
Status:
COMPLETED
Last Update Posted:
2017-03-30
First Post:
2005-06-30
Brief Title:
Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies
Sponsor:
Sunesis Pharmaceuticals
Organization:
Sunesis Pharmaceuticals
Study Overview
Official Title:
Phase 1b Open-Label Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Patients assigned to 1 of 2 schedules A and B in cohorts of at least 3 patients received vosaroxin SNS-595 intravenously IV for up to 4 cycles once weekly Days 1 8 15 in Schedule A or twice weekly Days 1 4 8 11 in Schedule B Dose escalation proceeded independently for Schedule A 18 mgm2 initially and Schedule B 9 mgm2 initially in the absence of Dose-limiting Toxicity DLT based on a modified Fibonacci sequence The incidence of DLT during Cycle 1 determined the maximum-tolerated dose MTD allowing for treatment delays of up to 14 days to resolve clinically significant abnormal laboratory values or related treatment-emergent adverse events TEAEs and one dose reduction of 25 in case of above Patients with stable disease hematologic improvement or partial remission with stable blast counts or experiencing clinical benefit in the opinion of the investigator were eligible to receive vosaroxin for up to 4 additional cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None