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Once weekly intravenous on days 1, 8, 15 up to 4 cycles

Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles

Vosaroxin

Glenn Michelson, MD

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.

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

Phase 1b Open-Label, Multicenter Clinical Study of the Safety and Activity of Intravenous Administration of SNS-595 in Patients With Advanced Hematologic Malignancies

Aggregate data of participants experiencing Adverse Events

Sunesis Pharmaceuticals

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Analgesics

Cytarabine

Mitoxantrone

Daunorubicin

randomization between two established Chemotherapies

Ulrich S. Schuler, PD Dr. med.

Single Arm-Studies suggest improved remission and survival rates for a Protocol with Mitoxantron 10mg/m2 for 3 days combined with AraC 1g/m2 bid on days 1+3+5+7 compared to a conventional DA 7+3 protocol (45mg/m2 Daunorubicin).

Randomized comparison of the two protocols.

Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC

Therapy of AML in Patients Older Than 60 Years: Randomized Comparison of a Double Induction With Daunorubicin and AraC (as Continuous Infusion) With a Double Induction With Mitoxantrone and Intermittent, Medium High Dose AraC

Technische Universität Dresden

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies	NCT00246662	Leukemia, Lymph... Leukemia, Nonly... Leukemia, Myelo... Myelodysplastic...	Vosaroxin	18 Years -	Sunesis Pharmaceuticals
Therapy of Acute Myeloid Leukemia in Patients Over the Age of 60 : DA Versus Mitoxantrone With Intermittent AraC	NCT00180167	Leukemia, Nonly...	randomization b...	60 Years -	Technische Universität Dresden

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