Leukemia, Acute Disease, Acute Myeloid Leukemia, Nonlymphocytic Leukemia, Myelodysplastic Syndromes
Conditions
Keywords
Leukemia, Myeloid, Elderly, Hematologic, Blood, Cancer, Malignancy, SNS-595, Sunesis, Hematologic Diseases, Myelodysplastic Syndromes, Older, voreloxin, reveal-1
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
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
Interventions
DRUGvosaroxin
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.
Sponsors
Sunesis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Leukemia-free Survival (LFS) | 2 years | The censor date was the last known alive date without report of relapse. |
| Overall Survival | 2 years | — |
| Pharmacokinetics Day 1 - Cmax (ng/mL) | 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) | 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 | 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) | 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 4 - Vss (L) | 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. |
| Pharmacokinetics Day 1 - CL (L/hr) | 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) | 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) | 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) | 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) | 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 1 - t1/2 (hr) and MRTinf (hr) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 The original Schedule A used a single arm Green Dahlberg design (Green 1992) with 30 patients planned to be treated in Stage I. | 29 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 Schedule B was to use a single arm Green Dahlberg 2 stage design with 30 patients planned to be treated in Stage I and 25 patients in Stage II. | 35 |
| Schedule C: 72 mg/m2 on Days 1 and 4 Schedule C (also implemented under Amendment 2) was a dosing schedule of 72 mg/m2 on Days 1 and 4, and a total of 29 patients were enrolled and treated at this dose | 29 |
| Schedule C: 90 mg/m2 on Days 1 and 4 Amendment 3 added a second dose cohort to Schedule C to treat approximately 10 patients with 90 mg/m2 vosaroxin on Days 1 and 4. | 20 |
| Total | 113 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 1 | 2 | 0 |
| Overall Study | Death | 8 | 5 | 2 | 5 |
| Overall Study | Lack of Efficacy | 6 | 20 | 14 | 10 |
| Overall Study | Other without explanation | 2 | 0 | 4 | 1 |
| Overall Study | Physician Decision | 4 | 1 | 0 | 0 |
| Overall Study | Relapse, recurrent illness | 4 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Total | Schedule C: 90 mg/m2 on Days 1 and 4 | Schedule C: 72 mg/m2 on Days 1 and 4 | Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 |
|---|---|---|---|---|---|
| Age, Continuous | 74.1 years STANDARD_DEVIATION 6.2 | 73.6 years STANDARD_DEVIATION 6.14 | 76.5 years STANDARD_DEVIATION 5.7 | 70.5 years STANDARD_DEVIATION 5.68 | 74.2 years STANDARD_DEVIATION 5.85 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 0 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 110 Participants | 20 Participants | 27 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 7 Participants | 0 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 102 Participants | 19 Participants | 26 Participants | 31 Participants |
| Sex: Female, Male Female | 10 Participants | 40 Participants | 3 Participants | 15 Participants | 12 Participants |
| Sex: Female, Male Male | 19 Participants | 73 Participants | 17 Participants | 14 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 25 / 29 | 31 / 35 | 28 / 29 | 19 / 20 |
| other Total, other adverse events | 29 / 29 | 35 / 35 | 29 / 29 | 20 / 20 |
| serious Total, serious adverse events | 25 / 29 | 29 / 35 | 21 / 29 | 17 / 20 |
Outcome results
Primary
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
Population: The all treated analysis set Included all enrolled patients who received any amount of vosaroxin.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | 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 | 41.4 percentage of patients |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | 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 | 25.7 percentage of patients |
| Schedule C: 72 mg/m2 on Days 1 and 4 | 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 | 34.5 percentage of patients |
| Schedule C: 90 mg/m2 on Days 1 and 4 | 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 | 25.0 percentage of patients |
| Total | 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 | 31.9 percentage of patients |
Secondary
All Cause Mortality
Mortality of those patients enrolled in the study and receiving intervention
Time frame: 30 and 60 days
Population: All treated analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | All Cause Mortality | 30-Day | 5 Participants |
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | All Cause Mortality | 60-Day | 11 Participants |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | All Cause Mortality | 30-Day | 3 Participants |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | All Cause Mortality | 60-Day | 13 Participants |
| Schedule C: 72 mg/m2 on Days 1 and 4 | All Cause Mortality | 30-Day | 2 Participants |
| Schedule C: 72 mg/m2 on Days 1 and 4 | All Cause Mortality | 60-Day | 5 Participants |
| Schedule C: 90 mg/m2 on Days 1 and 4 | All Cause Mortality | 60-Day | 6 Participants |
| Schedule C: 90 mg/m2 on Days 1 and 4 | All Cause Mortality | 30-Day | 2 Participants |
| Total | All Cause Mortality | 30-Day | 12 Participants |
| Total | All Cause Mortality | 60-Day | 35 Participants |
Secondary
Leukemia-free Survival (LFS)
The censor date was the last known alive date without report of relapse.
Time frame: 2 years
Population: All treated analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Leukemia-free Survival (LFS) | 9.8 Months |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Leukemia-free Survival (LFS) | 10.9 Months |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Leukemia-free Survival (LFS) | 5.5 Months |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Leukemia-free Survival (LFS) | 4.9 Months |
| Total | Leukemia-free Survival (LFS) | 6.1 Months |
Secondary
Overall Survival
Time frame: 2 years
Population: All treated patients
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Overall Survival | 8.6 Months |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Overall Survival | 5.8 Months |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Overall Survival | 7.8 Months |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Overall Survival | 5.6 Months |
| Total | Overall Survival | 7.0 Months |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUC0-72 (hr.ng/mL) | 36721 hr*ng/mL | Standard Deviation 21.1 |
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUCinf (hr.ng/mL) | 41903 hr*ng/mL | Standard Deviation 27.3 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUCinf (hr.ng/mL) | 47228 hr*ng/mL | Standard Deviation 28.7 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUC0-72 (hr.ng/mL) | 40092 hr*ng/mL | Standard Deviation 28.7 |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUCinf (hr.ng/mL) | 44848 hr*ng/mL | Standard Deviation 13 |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUC0-72 (hr.ng/mL) | 37401 hr*ng/mL | Standard Deviation 13.9 |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUCinf (hr.ng/mL) | 43838 hr*ng/mL | Standard Deviation 31.8 |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) | AUC0-72 (hr.ng/mL) | 38086 hr*ng/mL | Standard Deviation 28 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 1 - CL (L/hr) | 3.643 L/hr | Standard Deviation 30 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 1 - CL (L/hr) | 3.389 L/hr | Standard Deviation 33.4 |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - CL (L/hr) | 3.235 L/hr | Standard Deviation 15.2 |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - CL (L/hr) | 4.538 L/hr | Standard Deviation 25.3 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 9 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 1 - Cmax (ng/mL) | 3028 ng/mL | Standard Deviation 48.7 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 1 - Cmax (ng/mL) | 2450 ng/mL | Standard Deviation 47.8 |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - Cmax (ng/mL) | 2865 ng/mL | Standard Deviation 47.8 |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - Cmax (ng/mL) | 3328 ng/mL | Standard Deviation 69 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | t1/2 (hr) | 22.51 hr | Standard Deviation 36.6 |
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | MRTinf (hr) | 30.56 hr | Standard Deviation 41.4 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | t1/2 (hr) | 27.29 hr | Standard Deviation 21.2 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | MRTinf (hr) | 37.57 hr | Standard Deviation 23.5 |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | MRTinf (hr) | 37.16 hr | Standard Deviation 36.8 |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | t1/2 (hr) | 28.27 hr | Standard Deviation 32.1 |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | MRTinf (hr) | 32.10 hr | Standard Deviation 27 |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) | t1/2 (hr) | 23.57 hr | Standard Deviation 25.2 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 1. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for 10 patients in Schedule A, for 8 patients in Schedule B, for 6 patients in Schedule C, and for 8 patients in Schedule C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 1 - Vss (L) | 107.9 L | Standard Deviation 40.4 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 1 - Vss (L) | 129.9 L | Standard Deviation 50.2 |
| Schedule C: 72 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - Vss (L) | 116.6 L | Standard Deviation 28.5 |
| Schedule C: 90 mg/m2 on Days 1 and 4 | Pharmacokinetics Day 1 - Vss (L) | 139.2 L | Standard Deviation 21.1 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 8 patients in Schedule C.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL) | AUC0-72 (hr.ng/mL) | 35125 hr*ng/mL | Standard Deviation 23.8 |
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL) | AUCinf (hr.ng/mL) | 40539 hr*ng/mL | Standard Deviation 26.9 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL) | AUC0-72 (hr.ng/mL) | 43667 hr*ng/mL | Standard Deviation 32.3 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL) | AUCinf (hr.ng/mL) | 46462 hr*ng/mL | Standard Deviation 37.2 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 4 - CL (L/hr) | 4.387 L/hr | Standard Deviation 30.3 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 4 - CL (L/hr) | 4.882 L/hr | Standard Deviation 28.4 |
Secondary
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.
Time frame: Day 4
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data on Day 4 for 5 patients in Schedule C, and for 8 patients in Schedule C .
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 4 Cmax (ng/mL) | 5792 ng/mL | Standard Deviation 114.9 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 4 Cmax (ng/mL) | 4148 ng/mL | Standard Deviation 98.4 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data, for 5 patients in Schedule C, and for 7 patients in Schedule C.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr) | t1/2 (hr) | 23.52 hr | Standard Deviation 27.6 |
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr) | MRTinf (hr) | 31.83 hr | Standard Deviation 35.7 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr) | t1/2 (hr) | 20.41 hr | Standard Deviation 28.7 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr) | MRTinf (hr) | 27.79 hr | Standard Deviation 24.1 |
Secondary
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
Population: Patients Treated with Vosaroxin as a Single Agent (SPO-0014) on Day 4. Of 113 patients treated, PK data were available for 33 patients who received at least 1 dose of vosaroxin, PK profiles were evaluated for patients with data for Day 4, for 5 patients in Schedule C, and for 7 patients in Schedule C.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Schedule A: 72 mg/m2 Vosaroxin Days 1, 8 and 15 | Pharmacokinetics Day 4 - Vss (L) | 137.3 L | Standard Deviation 39.5 |
| Schedule B: 72 mg/m2 Vosaroxin on Days 1 and 8 | Pharmacokinetics Day 4 - Vss (L) | 132.7 L | Standard Deviation 34 |