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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

October 6, 2007

Primary Completion Date

February 15, 2012

Study Completion Date

February 15, 2012

Conditions
Acute Myeloid Leukemia
Interventions
DRUG

Voreloxin injection and cytarabine

"Dose-escalation Phase~* Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion of 400 mg/m2/day × 5 days)~* Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days)~Expansion Phase The MTD determined in the dose-escalation phase was used in the expansion phase.~* Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days)~* Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days)"

Trial Locations (9)

10065

New York Presbyterian Hospital-Weill Cornell Medical College, New York

21205

Johns Hopkins University - Sidney Kimmel Cancer Center, Baltimore

33612

H. Lee Moffitt Cancer Center, Tampa

46206

Indiana University Cancer Center, Indianapolis

60611

Northwestern Medical Faculty Foundation, Chicago

Northwestern Memorial Hospital, Chicago

77030

MD Anderson Cancer Center, Houston

80218

HealthOne Presbyterian/St. Luke's Medical Center, Denver

Rocky Mountain Cancer Centers, Denver

Sponsors
All Listed Sponsors
lead

Sunesis Pharmaceuticals

INDUSTRY