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SNS-314

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Viracta Therapeutics, Inc.|Last Updated: Apr 4, 2017

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00519662Safety and Tolerability Study of SNS-314 for Advanced Solid TumorsPHASE1 COMPLETED 32Aug 1, 2007Mar 1, 2009Apr 4, 20174 United States
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Study Endpoints
Primary Endpoints
To assess the safety and tolerability of SNS-314
1 Year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose escalating cohorts of SNS-314EXPERIMENTALSequential groups, starting at a dose of 30 mg/m2, will be escalated according to identification of dose limiting toxicities against various criteria. Doses escalated by doubling the dose until the first observation of clinically significant Grade 2 or greater toxicity related to SNS-314 injection. Results in dosing increments of 67%, 50%, 40%, 33%, and subsequently 25% based on modified Fibonacci schema.
Interventions
NameTypeDescription
SNS-314DRUGStage 1 - Escalating doses of SNS-314 Injection on days 1, 8 and 15 Stage 2 - Same as stage 1 except SNS-314 Injection is administered at the maximum tolerated dose established in stage 1
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Advanced solid tumor and that is measurable by a scan Exclusion Criteria: * Uncontrolled or untreated central nervous system metastases * Cerebrovascular accident/transient ischemic attack up to 6 months before Cycle 1 Day 1 * Any of the following cardiac conditions: * Histo...

Countries:United States
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