Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01191801 | Study of Vosaroxin or Placebo in Combination With Cytarabine in Patients With First Relapsed or Refractory AML | PHASE3 | COMPLETED | 711 | — | — | Dec 17, 2010 | Mar 1, 2017 | Aug 22, 2018 | 124 | United States, Australia +13 |
| NCT03338348 | Study of Vosaroxin With Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2 | PHASE2 | COMPLETED | 9 | — | — | Apr 19, 2018 | Oct 31, 2019 | Oct 28, 2020 | 3 | Germany |
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
Efficacy assessments
| Arm | Type | Description |
|---|---|---|
| Group A: vosaroxin + cytarabine | EXPERIMENTAL | vosaroxin (short IV infusion within 10 minutes) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation |
| Group B: placebo + cytarabine | PLACEBO_COMPARATOR | placebo (short IV infusion within 10 minutes and volume matched to vosaroxin) on days 1 and 4: cytarabine on days 1 through 5; a maximum of 2 cycles of Induction and 2 cycles for Consolidation |
| Azacitidine + Vosaroxin | OTHER | Cycle 1-8: Azacitidine: 75 mg/m²/d subcutaneously, d 1-7; Vosaroxin: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 . Patients who have completed 8 cycles of azacitidine and vosaroxin are scheduled to maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression. |
| Name | Type | Description |
|---|---|---|
| vosaroxin + cytarabine | DRUG | Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles Cytarabine 1 g/m2 daily on days 1-5 (IDAC) |
| placebo + cytarabine | DRUG | Placebo days 1 and 4: volume matched to vosaroxin Cytarabine 1 g/m2 daily on days 1-5 (IDAC) |
| Vosaroxin | DRUG | Cycle 1-8: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 . |
| Azacitidine | DRUG | Cycle 1-8 Azacitidine: 75 mg/m²/d subcutaneously, d 1-7; Maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression. |
Inclusion Criteria: * Provided signed, written informed consent * At least 18 years of age * Had a diagnosis of AML according to World Health Organization (WHO) classification * First relapsed or refractory AML (refractory to initial induction therapy) with at least 5% blasts by bone marrow or aspi...