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SNS-595

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Viracta Therapeutics, Inc.|Last Updated: Sep 24, 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

SNS-595 · 4 trials · 4 indications

Phase 2 2Phase 1 2
NCT00298896Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung CancerCarcinoma, Small Cell
COMPLETED55 Analytics
NCT00252382Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLCCarcinoma, Non-Small-Cell Lung
COMPLETED31 Analytics
PHASE2COMPLETED
Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung Cancer
Carcinoma, Small CellUnlock trial analytics
PHASE2COMPLETED
Safety and Efficacy Clinical Study of SNS-595 for Second-Line Therapy in Patients With Advanced NSCLC
Carcinoma, Non-Small-Cell LungUnlock trial analytics

Study Endpoints

Primary Endpoints

Objective Response Rate
up to 6 months

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

Objective Tumor Response Rate
168 days

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.

Secondary Endpoints

Best Overall Response
upto 6 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SNS-595EXPERIMENTALSNS-595; 48 mg/m2 administered IV once every 21 days for up to 6 cycles.
Treatment with 48 mg/m2 of SNS-595EXPERIMENTALPatients 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)

Interventions

NameTypeDescription
SNS-595DRUG -
SNS-595 InjectionDRUGVosaroxin (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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites17

Inclusion Criteria: * Able to understand and willing to sign a written informed consent document * Patients who have recurrent or refractory SCLC requiring second-line chemotherapy who previously received first-line chemotherapy * Measurable disease * Eastern Cooperative Oncology Group (ECOG) Perfo...

Countries:United StatesCanada
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Frequently asked questions about SNS-595

What is SNS-595 used for?

SNS-595 is an investigational small molecule being studied for the treatment of solid tumors, including non-small-cell lung carcinoma and small cell lung cancer. It has been evaluated in clinical trials for patients with advanced non-small-cell lung cancer and small cell lung cancer.

Who makes SNS-595?

SNS-595 is being developed by Viracta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VIRX. The company is conducting clinical research on this investigational oncology drug.

What phase is SNS-595 in?

SNS-595 has completed Phase 2 clinical trials for the treatment of advanced non-small-cell lung cancer and small cell lung cancer. It is an investigational drug that has not been approved by regulatory authorities and remains in clinical development.

What clinical trials has SNS-595 been in?

SNS-595 has been studied in two completed Phase 1 trials (NCT00091585 and NCT00094159) for solid tumors, and two completed Phase 2 trials: NCT00252382 for advanced non-small-cell lung cancer and NCT00298896 for small cell lung cancer.

Is SNS-595 the same as any other drug?

No alternative names for SNS-595 have been disclosed in the available clinical trial information. The drug is identified solely by its code name SNS-595 in the registered studies.