This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
January 23, 2008
May 25, 2017
May 15, 2008
November 2009   (Final data collection date for primary outcome measure)
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.

To assess the efficacy of SNS-595 [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00607997 on ClinicalTrials.gov Archive Site
  • 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.

  • Safety [ Time Frame: 1 year ]
  • Survival [ Time Frame: 1 year ]
  • Pharmacokinetics [ Time Frame: 1 year ]
  • Evaluate potential biomarkers [ Time Frame: 1 year ]
Not Provided
Not Provided
 
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
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

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
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
  • Leukemia
  • Acute Disease
  • Acute Myeloid Leukemia
  • Nonlymphocytic Leukemia
  • Myelodysplastic Syndromes
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
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
Intervention: Drug: vosaroxin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
113
November 23, 2009
November 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00607997
SPO-0014
No
Not Provided
Plan to Share IPD: Yes
Plan Description: De-identified data of individual participants experiencing Serious Adverse Events
Sunesis Pharmaceuticals
Sunesis Pharmaceuticals
Not Provided
Study Director: Adam Craig, MD Sunesis Pharmaceuticals
Sunesis Pharmaceuticals
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP