Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Voreloxin and cytarabine · 1 trial · 1 indication
Patients were treated in cohorts with escalating doses of vosaroxin administered in combination with cytarabine in Schedule A, and with vosaroxin in escalating doses in Schedule B. For both Schedules, the highest dose at which fewer than 2 of 6 (\<0.33) patients experienced a dose-limiting toxicity (DLT) during induction became the MTD and the recommended future dose.
| Arm | Type | Description |
|---|---|---|
| Voreloxin injection and cytarabine | EXPERIMENTAL | Dose-escalation Phase * Schedule A: * Schedule B: Expansion Phase * Schedule A: * Schedule B: |
| Name | Type | Description |
|---|---|---|
| Voreloxin injection and cytarabine | DRUG | Dose-escalation Phase * Schedule A: vosaroxin injection (dose-escalation from 10 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion of 400 mg/m2/day × 5 days) * Schedule B: vosaroxin injection (dose-escalation from 70 to 90 mg/m2) on Days 1 and 4 in combination with cytarabine (2-hour intravenous \[IV\] infusion of 1 g/m2/day × 5 days) Expansion Phase The MTD determined in the dose-escalation phase was used in the expansion phase. * Schedule A: 80 mg/m2 vosaroxin on Days 1 and 4 in combination with cytarabine (24-hour CIV infusion at 400 mg/m2/day × 5 days) * Schedule B: 90 mg/m2 vosaroxin (dose-escalation) on Days 1 and 4 in combination with cytarabine (2 hour IV infusion at 1 g/m2/day × 5 days) |
KEY INCLUSION CRITERIA 1. Relapsed or refractory AML subtypes defined by WHO, except acute promyelocytic leukemia. Relapsed/refractory disease may be de novo AML or secondary AML 2. Treated with one to threee induction/reinduction AML regimens, prior induction or consolidation therapy with cytarabi...
Voreloxin is an investigational small molecule being studied for the treatment of epithelial ovarian cancer and acute myeloid leukemia. In clinical trials, it has been evaluated in patients with platinum-resistant ovarian cancer and in combination with cytarabine for acute myeloid leukemia.
Voreloxin is being developed by Viracta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIRX.
Voreloxin is in Phase 2 clinical development for epithelial ovarian cancer. A Phase 1 study has also been completed for acute myeloid leukemia. The drug is investigational and has not been approved by regulatory authorities.
Voreloxin has been studied in two completed clinical trials. NCT00408603 was a Phase 2 study in 183 patients with platinum-resistant epithelial ovarian cancer. NCT00541866 was a Phase 1 study of Voreloxin combined with cytarabine in 110 patients with acute myeloid leukemia.
Yes, Voreloxin was previously known as SNS-595. The Phase 2 clinical trial in ovarian cancer, NCT00408603, was originally titled as a study of SNS-595 in patients with platinum-resistant ovarian cancer.