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SAR245408

Phase 1

Solid Tumors | Small molecule | Oncology |Sanofi|Last Updated: Apr 1, 2016

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 Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01357330Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid TumorsPHASE1 COMPLETED 18May 1, 2011Jun 1, 2012Apr 1, 20163 United States
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Study Endpoints
Primary Endpoints
Identification of maximum tolerated dose
up to 4 years
Secondary Endpoints
Number of participants with treatment emergent adverse events
up to 4 years
Pharmakokinetic parameters of SAR245408: Cmax
up to 4 years
Pharmakokinetic parameters of SAR245408: Tmax
up to 4 years
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALDose escalation phase The starting dose of SAR245408 will be 25-mg once daily (up to 200-mg). The starting dose of MSC1936369B will be 15- mg once daily (up to 90-mg)
Interventions
NameTypeDescription
SAR245408 (XL147)DRUGPharmaceutical form:capsule and tablet Route of administration: oral
MSC1936369BDRUGPharmaceutical form:capsule Route of administration: oral
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion criteria: Patient with advanced solid tumors for which there is no approved or curative therapy: * has any advanced solid tumor with diagnosed alteration in 1 or more genes of the PI3K, and mitogen-activated protein kinase (MAPK) pathways and/or * has a histologically or cytologically co...

Countries:United States
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