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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00607997
First received: January 23, 2008
Last updated: May 25, 2017
Last verified: May 2017
  Purpose
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

Condition Intervention Phase
Leukemia Acute Disease Acute Myeloid Leukemia Nonlymphocytic Leukemia Myelodysplastic Syndromes Drug: vosaroxin Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sunesis Pharmaceuticals:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 years ]

    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.



Secondary Outcome Measures:
  • Leukemia-free Survival (LFS) [ Time Frame: 2 years ]
    The censor date was the last known alive date without report of relapse.

  • Overall Survival [ Time Frame: 2 years ]
  • Pharmacokinetics Day 1 - Cmax (ng/mL) [ Time Frame: 1 Day ]

    Pharmacokinetic Parameters (Cmax) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.


  • Pharmacokinetics Day 4 Cmax (ng/mL) [ Time Frame: Day 4 ]

    Pharmacokinetic Parameters by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) on Day 4

    Please note that N, mean and CV% are reported, but CV% is not an option in the drop down menu. So Standard Deviation is really CV% in the table.


  • All Cause Mortality [ Time Frame: 30 and 60 days ]
    Mortality of those patients enrolled in the study and receiving intervention

  • Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) [ Time Frame: 1 Day ]

    Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.


  • Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) [ Time Frame: 1 Day ]

    Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.


  • Pharmacokinetics Day 1 - CL (L/hr) [ Time Frame: 1 Day ]

    Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.


  • Pharmacokinetics Day 1 - Vss (L) [ Time Frame: 1 Day ]

    Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 1

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.


  • Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL) [ Time Frame: Day 4 ]

    Pharmacokinetic Parameters (AUC0-72 and AUCinf ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. Standard Deviation is really CV% in the table.


  • Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr) [ Time Frame: Day 4 ]

    Pharmacokinetic Parameters (t1/2 and and MRTinf) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The Standard Deviation is really CV% in the table.


  • Pharmacokinetics Day 4 - CL (L/hr) [ Time Frame: Day 4 ]

    Pharmacokinetic Parameters (CL) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.


  • Pharmacokinetics Day 4 - Vss (L) [ Time Frame: Day 4 ]

    Pharmacokinetic Parameters (Vss ) by Schedule, Dosing Day, and Dose Cohort for Patients Treated With Vosaroxin as a Single Agent (SPO 0014) for Day 4

    Numbers reported are N, mean and CV%. Please note CV% is not a choice that can be entered from the drop down menu. The standard deviation is really CV% in the table.



Enrollment: 113
Actual Study Start Date: May 15, 2008
Study Completion Date: November 23, 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
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.
Other Names:
  • voreloxin
  • SNS-595

Detailed Description:

Other objectives of this study include:

  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
  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. 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)
  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

Key Exclusion Criteria:

  1. Uncontrolled DIC
  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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607997

Locations
United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Scripps Cancer Center
La Jolla, California, United States, 92037
United States, Colorado
Rocky Mountain Blood and Marrow Transplant Program
Denver, Colorado, United States, 80218
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
The University of Chicago
Chicago, Illinois, United States, 60637
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46206
St. Francis Hospital & Health Systems at Beech Grove Campus
Indianapolis, Indiana, United States, 46237
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67208
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Louisiana
LSU Health Sciences Center at Shreveport
Shreveport, Louisiana, United States, 71103
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
University of MO Ellis Fischel Cancer Center
Columbia, Missouri, United States, 65203
United States, Pennsylvania
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
Huntsman Cancer Institute at the University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Sunesis Pharmaceuticals
Investigators
Study Director: Adam Craig, MD Sunesis Pharmaceuticals
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sunesis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00607997     History of Changes
Other Study ID Numbers: SPO-0014
Study First Received: January 23, 2008
Results First Received: March 27, 2017
Last Updated: May 25, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: De-identified data of individual participants experiencing Serious Adverse Events

Keywords provided by Sunesis Pharmaceuticals:
Leukemia
Myeloid
Elderly
Hematologic
Blood
Cancer
Malignancy
SNS-595
Sunesis
Hematologic Diseases
Myelodysplastic Syndromes
Older
voreloxin
reveal-1

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on June 28, 2017