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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
113
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.
Mayo Clinic Hospital
Phoenix, Arizona, United States
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.
Time frame: 2 years
Leukemia-free Survival (LFS)
The censor date was the last known alive date without report of relapse.
Time frame: 2 years
Overall Survival
Time frame: 2 years
Pharmacokinetics Day 1 - Cmax (ng/mL)
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.
Time frame: 1 Day
Pharmacokinetics Day 4 Cmax (ng/mL)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 10 more locations
Time frame: Day 4
All Cause Mortality
Mortality of those patients enrolled in the study and receiving intervention
Time frame: 30 and 60 days
Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL)
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.
Time frame: 1 Day
Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr)
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.
Time frame: 1 Day
Pharmacokinetics Day 1 - CL (L/hr)
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.
Time frame: 1 Day
Pharmacokinetics Day 1 - Vss (L)
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.
Time frame: 1 Day
Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL)
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.
Time frame: Day 4
Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr)
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.
Time frame: Day 4
Pharmacokinetics Day 4 - CL (L/hr)
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.
Time frame: Day 4
Pharmacokinetics Day 4 - Vss (L)
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.
Time frame: Day 4