Phase 2
N=113
Study of Voreloxin (Vosaroxin) in Older Patients With Untreated Acute Myeloid Leukemia
Leukemia · Acute Disease · Acute Myeloid Leukemia · Nonlymphocytic Leukemia · Myelodysplastic Syndromes
Bottom Line
View on ClinicalTrials.gov: NCT00607997 ↗Enrolled (actual)
113
Serious AEs
81.4%
Results posted
Jun 2017
Primary outcome: 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 — 41.4; 25.7; 34.5; 25.0 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- vosaroxin (Drug)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Sunesis Pharmaceuticals
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
41.4; 25.7; 34.5; 25.0; 31.9 | — |
| SECONDARY Leukemia-free Survival (LFS) |
9.8; 10.9; 5.5; 4.9; 6.1 | — |
| SECONDARY Overall Survival |
8.6; 5.8; 7.8; 5.6; 7.0 | — |
| SECONDARY Pharmacokinetics Day 1 - Cmax (ng/mL) |
3028; 2450; 2865; 3328 | — |
| SECONDARY Pharmacokinetics Day 4 Cmax (ng/mL) |
5792; 4148 | — |
| SECONDARY All Cause Mortality |
5; 3; 2; 2; 12; 11 | — |
| SECONDARY Pharmacokinetics Day 1 - AUC0-72 and AUCinf (hr*ng/mL) |
36721; 40092; 37401; 38086; 41903; 47228 | — |
| SECONDARY Pharmacokinetics Day 1 - t1/2 (hr) and MRTinf (hr) |
22.51; 27.29; 28.27; 23.57; 30.56; 37.57 | — |
| SECONDARY Pharmacokinetics Day 1 - CL (L/hr) |
3.643; 3.389; 3.235; 4.538 | — |
| SECONDARY Pharmacokinetics Day 1 - Vss (L) |
107.9; 129.9; 116.6; 139.2 | — |
| SECONDARY Pharmacokinetics Day 4 - AUC0-72 and AUCinf (hr*ng/mL) |
35125; 43667; 40539; 46462 | — |
| SECONDARY Pharmacokinetics Day 4 - t1/2 (hr) and MRTinf (hr) |
23.52; 20.41; 31.83; 27.79 | — |
| SECONDARY Pharmacokinetics Day 4 - CL (L/hr) |
4.387; 4.882 | — |
| SECONDARY Pharmacokinetics Day 4 - Vss (L) |
137.3; 132.7 | — |
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
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT00607997). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.