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SN2310 Injectable Emulsion

Phase 1

Breast Neoplasms | Small molecule | Oncology |Achieve Life Sciences, Inc.|Last Updated: Jun 4, 2009

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
UNCONTROLLED
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00385177Phase 1 Dose Escalation Study of SN2310 Injectable Emulsion in Patients With Advanced Solid TumorsPHASE1 COMPLETED 61Sep 1, 2006May 1, 2009Jun 4, 20092 United States
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Study Endpoints
Primary Endpoints
Maximum Tolerated Dose
December 2008
Dose-Limiting Toxicity
December 2008
Adverse Events
December 2008
Pharmacokinetic parameters for SN2310 and SN-38
December 2008
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALSN2310 Injectable Emulsion
Interventions
NameTypeDescription
SN2310 Injectable EmulsionDRUGEscalating doses given IV every three weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of solid tumor with disease progression despite standard therapy and/or for which no other solid therapeutic option exists * ANC \> 1,500 cell/mm3, platelets \> 100,000/mm3 and Hgb \> 9 g/dl * At least one unidimensionally me...

Countries:United States
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