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Completed

NCT Number: NCT00607997

Study of Voreloxin (Vosaroxin) in Older Patients With 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

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Key information

Conditions

Leukemia Acute Disease Acute Myeloid Leukemia Bone Marrow Diseases Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Nonlymphocytic Leukemia Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic Hospital, Phoenix, Arizona, United States

Loading trial locations.

About this study

Other objectives of this study include:

  • Assess the safety of treatment with vosaroxin, including the 30 and 60 day all-cause mortality
  • Assess leukemia free survival (LFS), event-free survival (EFS), overall survival (OS), and duration of remission (DR).
  • Characterize the pharmacokinetic (PK) profile of vosaroxin in this patient population.
  • Evaluate potential stratification biomarkers by evaluating DNA-damage and apoptotic pathways in bone marrow samples before and after treatment with vosaroxin

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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)

Treatment and study plan

Vosaroxin

Drug

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

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

    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 outcomes

  1. Leukemia-free Survival (LFS)

    Time frame: 2 years

    The censor date was the last known alive date without report of relapse.

  2. Overall Survival

    Time frame: 2 years

  3. 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.

  4. 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.

  5. All Cause Mortality

    Time frame: 30 and 60 days

    Mortality of those patients enrolled in the study and receiving intervention

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

Sunesis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 6, 2008
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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