Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia

PHASE2CompletedINTERVENTIONAL
Enrollment

113

Participants

Timeline

Start Date

May 15, 2008

Primary Completion Date

November 30, 2009

Study Completion Date

November 23, 2009

Conditions
LeukemiaAcute DiseaseAcute Myeloid LeukemiaNonlymphocytic LeukemiaMyelodysplastic Syndromes
Interventions
DRUG

vosaroxin

Vosaroxin was administered by slow intravenous (IV) infusion or via syringe pump within 10 minutes.Patients could have completed up to 4 treatment cycles consisting of 1 or 2 induction treatment cycles and up to 2 consolidation treatment cycles. For Schedule A, an induction cycle was a minimum of 21 days during which patients received vosaroxin on Days 1, 8, and 15, followed by weekly observations until hematologic recovery for patients with aplastic marrow after the postinduction bone marrow assessment. For Schedules B and C, an induction cycle was a minimum of 15 days, during which patients received vosaroxin on Days 1 and 8 (Schedule B), or Days 1 and 4 (Schedule C), followed by the same weekly observations until hematologic recovery as for Schedule A.

Trial Locations (20)

15232

University of Pittsburgh Cancer Institute, Pittsburgh

29425

Hollings Cancer Center at Medical University of South Carolina, Charleston

37232

Vanderbilt-Ingram Cancer Center, Nashville

39216

University of Mississippi Medical Center, Jackson

46206

Indiana University Cancer Center, Indianapolis

46237

St. Francis Hospital & Health Systems at Beech Grove Campus, Indianapolis

60612

Rush University Medical Center, Chicago

60637

The University of Chicago, Chicago

65203

University of MO Ellis Fischel Cancer Center, Columbia

67208

Cancer Center of Kansas, Wichita

67214

Cancer Center of Kansas, Wichita

71103

LSU Health Sciences Center at Shreveport, Shreveport

77030

MD Anderson Cancer Center, Houston

80218

Rocky Mountain Blood and Marrow Transplant Program, Denver

84112

Huntsman Cancer Institute at the University of Utah, Salt Lake City

85054

Mayo Clinic Hospital, Phoenix

85259

Mayo Clinic Scottsdale, Scottsdale

92037

Scripps Cancer Center, La Jolla

02114

Massachusetts General Hospital, Boston

02115

Dana-Farber Cancer Institute, Boston

Sponsors
All Listed Sponsors
lead

Sunesis Pharmaceuticals

INDUSTRY