Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans

Phase 1/2 Completed 110 enrolled Sunesis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate the safety and tolerability of voreloxin (vosaroxin) injection in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia.

Timeline

Start: 2007-10-06
Primary completion: 2012-02-15
Completion: 2012-02-15

Publications

Lancet JE, Roboz GJ, Cripe LD, Michelson GC, Fox JA, Leavitt RD, Chen T, Hawtin R, Craig AR, Ravandi F, Maris MB, Stuart RK, Karp JE. A phase 1b/2 study of vosaroxin in combination with cytarabine in patients with relapsed or refractory acute myeloid leukemia. Haematologica. 2015 Feb;100(2):231-7. doi: 10.3324/haematol.2014.114769. Epub 2014 Nov 7.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytarabine	Small molecule	200 mg/m2	Intravenous
Subject	Cytarabine	Small molecule	400 mg/m2	Intravenous
Subject	Cytarabine	Small molecule	1000 mg/m2	Intravenous
Subject	Vosaroxin	Small molecule	10 mg/m2	Other
Subject	Vosaroxin	Small molecule	50 mg/m2	Other
Subject	Vosaroxin	Small molecule	70 mg/m2	Other
Subject	Vosaroxin	Small molecule	80 mg/m2	Other
Subject	Vosaroxin	Small molecule	90 mg/m2	Other

Safety and Tolerability Study of Voreloxin and Cytarabine Combination in Acute Myeloid Leukemia in Humans

Summary

Timeline

Publications

Drugs

Indications