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.
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 mg/m2 initially) and Schedule B (9 mg/m2 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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
All patients receive vosaroxin Injection
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
New Mexico Cancer Care Alliance
Albuquerque, New Mexico, United States
Safety and tolerability
Time frame: 6 months
Pharmacokinetic profile
Time frame: 6 months
Duration of leukemia-free survival
Time frame: 6 months
Anti-tumor activity
Time frame: 6 months
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University of Texas, MD Anderson Cancer Center
Houston, Texas, United States