Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
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| ClinicalTrials.gov Identifier: NCT00607997 |
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Recruitment Status :
Completed
First Posted : February 6, 2008
Results First Posted : June 28, 2017
Last Update Posted : June 28, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Leukemia Acute Disease Acute Myeloid Leukemia Nonlymphocytic Leukemia Myelodysplastic Syndromes | Drug: vosaroxin | Phase 2 |
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
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 113 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| 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 |
| Actual Study Start Date : | May 15, 2008 |
| Actual Primary Completion Date : | November 2009 |
| Actual Study Completion Date : | November 23, 2009 |
| Arm | Intervention/treatment |
|---|---|
Experimental: All Study Patients
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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:
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- 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.
- 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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 60 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607997
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| Study Director: | Adam Craig, MD | Sunesis Pharmaceuticals |
| Responsible Party: | Sunesis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00607997 |
| Other Study ID Numbers: |
SPO-0014 |
| First Posted: | February 6, 2008 Key Record Dates |
| Results First Posted: | June 28, 2017 |
| Last Update Posted: | June 28, 2017 |
| Last Verified: | May 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-identified data of individual participants experiencing Serious Adverse Events |
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Leukemia Myeloid Elderly Hematologic Blood Cancer Malignancy |
SNS-595 Sunesis Hematologic Diseases Myelodysplastic Syndromes Older voreloxin reveal-1 |
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Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Preleukemia Myelodysplastic Syndromes Acute Disease Pathologic Processes |
Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Disease Attributes |