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Also known as SNS-595 Injection, Voreloxin, Vosaroxin
SNS-595 · 11 trials · 14 indications
Vosaroxin + cytarabine patient survival versus placebo + cytarabine patient survival
Objective tumor response rate based on the RECIST criteria for target lesions as assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD), at least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Overall Response (OR) = CR + PR
ORR is based on RECIST criteria to SNS-595 as a second-line therapy in patients with advanced NSCLC. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST) assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
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.
Efficacy assessments
Maximum tolerated dose (MTD) defined as highest daily oral dose evaluated at which \<33% of patients experience a dose limiting toxicity (DLT). A non-hematologic dose-limiting toxicity (DLT) defined as a clinically significant grade 3 or 4 adverse event or abnormal laboratory value (according to CTCAE criteria) assessed by treating physician as related to study drug (and unrelated to disease progression, intercurrent illness, or concomitant medications) occurring during the first 28 days on study. A hematologic DLT defined as severe myelosuppression with a hypoplastic marrow with less than 5% cellularity and no evidence of leukemia 42 days from start of therapy. This will define severe and delayed myelosuppression not related to persistent leukemia and likely related to treatment.
Maximum tolerated dose of vosaroxin for short IV infusion in INT-2 or high-risk MDS
Defined as the highest dose of vosaroxin that results in a DLT in =\< 1 of 6 patients graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 4.0
| 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 |
| SNS-595 | EXPERIMENTAL | SNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles. |
| Treatment with 48 mg/m2 of SNS-595 | EXPERIMENTAL | Patients are treated with 48 mg/m2 of the drug SNS-595 injection once every 21 days for up to 6 cycles as a second -line therapy to patients with advanced non-small cell lung cancer (NSCLC) |
| All Study Patients | EXPERIMENTAL | * Schedule A: 72 mg/m2 vosaroxin Days 1, 8 and 15 * Schedule B: 72 mg/m2 vosaroxin on Days 1 and 8 * Schedule C: 72 mg/m2 on Days 1 and 4, or * Schedule C: 90 mg/m2 on Days 1 and 4 |
| 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. |
| Vosaroxin + Decitabine | EXPERIMENTAL | The first 6 patients on study (first cohort) receive 1 or 2 induction cycles of therapy according to the following starting schedule: Vosaroxin administered intravenously on days 1 and 4 at a dose of 90 mg/m2 in the first cycle (induction 1) for a total dose of 180 mg/m2/cycle in combination with Decitabine at a dose of 20 mg/m2 intravenously daily for 5 consecutive days (Days 1 to 5). Following the phase I portion, patients in phase II receive the following induction: 1. Vosaroxin intravenously on days 1 and 4 at a dose of 70 mg/m2 for a total dose of 140 mg/m2/cycle (days 1 and 4), or the final induction dose (MTD) determined in phase I. 2. Decitabine intravenously at a dose of 20 mg/m2 for 5 consecutive days (days 1 to 5), or the final induction dose (MTD) determined in phase I. |
| Sch A (18 mg/m2 vosaroxin initially) | EXPERIMENTAL | Once weekly intravenous on days 1, 8, 15 up to 4 cycles |
| Sch B (9 mg/m2 vosaroxin initially) | EXPERIMENTAL | Twice weekly intravenous administration on days 1, 4, 8, 11 up to 4 cycles |
| Vosaroxin: All Patients | EXPERIMENTAL | All patients will receive vosaroxin according to the dose cohort in which they are enrolled. |
| Treatment (vosaroxin, azacitidine) | EXPERIMENTAL | Patients receive vosaroxin IV over 10 minutes on days 1 and 4 and azacitidine SC or IV over 15 minutes on days 1-7. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| 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) |
| SNS-595 | DRUG | - |
| SNS-595 Injection | DRUG | Vosaroxin (formerly voreloxin or SNS-595) is a first in class anticancer quinolone derivative, non anthracycline topoisomerase II inhibitor. It induces replication dependent DNA damage by intercalating DNA and inhibiting topoisomerase II, leading to apoptosis. |
| vosaroxin | DRUG | 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. |
| 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. |
| Decitabine | DRUG | Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5). |
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...
SNS-595 is an investigational small molecule oncology drug developed by Viracta Therapeutics, Inc. (ticker VIRX). It has been studied in Phase 2 clinical trials for advanced small cell lung cancer and non-small cell lung cancer, as well as in Phase 1 trials for solid tumors. It is not approved and remains in clinical development.
SNS-595 has been studied for the treatment of advanced small cell lung cancer and advanced non-small cell lung cancer, and for solid tumors generally. Its Phase 2 trials evaluated it in small cell lung cancer and as second-line therapy in non-small cell lung cancer. It is investigational and not approved for any indication.
SNS-595 is developed by Viracta Therapeutics, Inc., which trades under the ticker VIRX. The company sponsored the clinical studies of SNS-595 in small cell lung cancer, non-small cell lung cancer, and solid tumors.
SNS-595 is in Phase 2 development. Two Phase 2 trials have been completed, one in advanced small cell lung cancer and one as second-line therapy in advanced non-small cell lung cancer. Two Phase 1 safety trials in solid tumors have also been completed. SNS-595 is investigational and not FDA approved.
SNS-595 has been studied in completed trials including NCT00298896, a Phase 2 study in advanced small cell lung cancer with 55 patients in the United States and Canada, and NCT00252382, a Phase 2 second-line study in advanced non-small cell lung cancer with 31 patients in the United States. Phase 1 solid tumor trials NCT00094159 and NCT00091585 are also completed.
Yes, SNS-595 Injection is another name for SNS-595. Both refer to the same investigational small molecule developed by Viracta Therapeutics, Inc. (ticker VIRX) and studied in lung cancer and solid tumor clinical trials.