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SNS-595

Phase 2

Carcinoma, Small Cell | Small molecule | Oncology |Viracta Therapeutics, Inc.|Last Updated: Jul 26, 2018

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment55
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00298896Safety and Efficacy Clinical Study of SNS-595 in Patients With Advanced Small Cell Lung CancerPHASE2 COMPLETED 55Feb 1, 2006Jun 1, 2008Jul 26, 201817 United States, Canada
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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

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.
Interventions
NameTypeDescription
SNS-595DRUG -
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Eligibility Criteria
Age Range18 Years — 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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