Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
NCT ID: NCT00607997
Last Updated: 2017-06-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
113 participants
INTERVENTIONAL
2008-05-15
2009-11-23
Brief Summary
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Detailed Description
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1. Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
2. Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
3. Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
4. Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All Study Patients
* Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15
* Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8
* Schedule C: 72 mg/m2 on Days 1 and 4, or
* Schedule C: 90 mg/m2 on Days 1 and 4
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least 20% blasts by BM biopsy or aspirate
3. ECOG performance status of 0,1,or 2
4. Adequate cardiac, renal and liver function
Exclusion Criteria
2. Active central nervous system involvement by AML
3. Requiring hemodialysis or peritoneal dialysis
4. Some prior history of heart attack or stroke (depending on how long ago the event occurred)
60 Years
ALL
No
Sponsors
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Sunesis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Adam Craig, MD
Role: STUDY_DIRECTOR
Sunesis Pharmaceuticals
Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States
Scripps Cancer Center
La Jolla, California, United States
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States
Rush University Medical Center
Chicago, Illinois, United States
The University of Chicago
Chicago, Illinois, United States
Indiana University Cancer Center
Indianapolis, Indiana, United States
St. Francis Hospital & Health Systems at Beech Grove Campus
Indianapolis, Indiana, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Cancer Center of Kansas
Wichita, Kansas, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
University of MO Ellis Fischel Cancer Center
Columbia, Missouri, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Stuart RK, Cripe LD, Maris MB, Cooper MA, Stone RM, Dakhil SR, Turturro F, Stock W, Mason J, Shami PJ, Strickland SA, Costa LJ, Borthakur G, Michelson GC, Fox JA, Leavitt RD, Ravandi F. REVEAL-1, a phase 2 dose regimen optimization study of vosaroxin in older poor-risk patients with previously untreated acute myeloid leukaemia. Br J Haematol. 2015 Mar;168(6):796-805. doi: 10.1111/bjh.13214. Epub 2014 Nov 17.
Other Identifiers
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SPO-0014
Identifier Type: -
Identifier Source: org_study_id
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