Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
A Phase 2, Open-Label, Multicenter Clinical Study of the Safety and Efficacy of Voreloxin (Vosaroxin) Injection in Patients Equal to or Greater Than 60 Years of Age With Previously Untreated Acute Myeloid Leukemia
1 other identifier
interventional
113
1 country
20
Brief Summary
This study will evaluate the overall remission rate of treatment with vosaroxin (formerly voreloxin) Injection in patients at least 60 years of age with previously untreated AML
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 leukemia
Started May 2008
Shorter than P25 for phase_2 leukemia
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
February 6, 2008
CompletedStudy Start
First participant enrolled
May 15, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 23, 2009
CompletedResults Posted
Study results publicly available
June 28, 2017
CompletedJune 28, 2017
May 1, 2017
1.5 years
January 23, 2008
March 27, 2017
May 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Remission Rate Defined as the Percentage of Patients Whose Respnse is CR or CRp Based on International Working Group (IWG) Response Criteria and Treatment Outcomes Definitions
Combined remission rate (complete remission \[CR\] + complete remission with incomplete platelet recovery \[CRp\]) of vosaroxin of patients ≥ 60 years old with previously untreated (de novo or secondary) AML are presented by treatment group for all treated analysis set. Per IWG criteria, a CR requires bone marrow blasts \< 5%, absolute neutrophil count (ANC) \> 1000 cells/uL, and platelet (plt) count \> 100,000 plt/uL. The criteria for CRp are the same as those for CR, except for platelet count \<= 100,000 lt/uL. Investigators were to determine a response category for each patient by examination of bone marrow and blood counts at the time of hematologic recovery after induction or reinduction. Investigator assessment categories included CR, CRp, CRi (Morphologic CR with incomplete blood count recovery), PR (partial remission), treatment failure, and relapse.
2 years
Secondary Outcomes (13)
Leukemia-free Survival (LFS)
2 years
Overall Survival
2 years
Pharmacokinetics Day 1 - Cmax (ng/mL)
1 Day
Pharmacokinetics Day 4 Cmax (ng/mL)
Day 4
All Cause Mortality
30 and 60 days
- +8 more secondary outcomes
Study Arms (1)
All Study Patients
EXPERIMENTAL* 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- At least 60 years of age and diagnosis of previously untreated AML (either de novo or from an antecedent hematologic disorder or therapy related AML)
- At least 20% blasts by BM biopsy or aspirate
- ECOG performance status of 0,1,or 2
- Adequate cardiac, renal and liver function
You may not qualify if:
- Uncontrolled DIC
- Active central nervous system involvement by AML
- Requiring hemodialysis or peritoneal dialysis
- Some prior history of heart attack or stroke (depending on how long ago the event occurred)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Mayo Clinic Hospital
Phoenix, Arizona, 85054, United States
Mayo Clinic Scottsdale
Scottsdale, Arizona, 85259, United States
Scripps Cancer Center
La Jolla, California, 92037, United States
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, 80218, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
The University of Chicago
Chicago, Illinois, 60637, United States
Indiana University Cancer Center
Indianapolis, Indiana, 46206, United States
St. Francis Hospital & Health Systems at Beech Grove Campus
Indianapolis, Indiana, 46237, United States
Cancer Center of Kansas
Wichita, Kansas, 67208, United States
Cancer Center of Kansas
Wichita, Kansas, 67214, United States
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, 71103, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
University of MO Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, 15232, United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, 84112, United States
Related Publications (1)
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.
PMID: 25403830DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Due to the limited sample size in this study, further study is needed to confirm these results. No statistical testings were performed to compare any of the treatment groups. No p-values or odds ratios were reported.
Results Point of Contact
- Title
- Linda Neuman, Vice President, Clinical Development
- Organization
- Sunesis Pharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Adam Craig, MD
Sunesis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
February 6, 2008
Study Start
May 15, 2008
Primary Completion
November 1, 2009
Study Completion
November 23, 2009
Last Updated
June 28, 2017
Results First Posted
June 28, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will share
De-identified data of individual participants experiencing Serious Adverse Events