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

Phase 1

Completed

• Conditions: Leukemia, Lymphocytic, Acute; Myelodysplastic Syndromes; Leukemia, Myeloid, Chronic; Leukemia, Nonlymphocytic, Acute
• Interventions: Drug: Vosaroxin

• Registration Number: NCT00246662
• Lead Sponsor: Sunesis Pharmaceuticals

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 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 Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-30
• Study Start: 2005-11-14
• Primary Completion: 2008-12-23
• Study Completion: 2009-04
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-28
• Last Update Posted: 2017-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sch A (18 mg/m2 vosaroxin initially)	Vosaroxin	Once weekly intravenous on days 1, 8, 15 up to 4 cycles
Sch B (9 mg/m2 vosaroxin initially)	Vosaroxin	Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	6 months

Secondary Outcome Measures

Name	Time	Method
Duration of leukemia-free survival	6 months
Anti-tumor activity	6 months
Pharmacokinetic profile	6 months

Trial Locations

Locations (5)

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

H. Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Indiana University Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

University of Texas, MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

New Mexico Cancer Care Alliance; 🇺🇸 Albuquerque, New Mexico, United States