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Xaliproden

Phase 3

Metastases | Small molecule | Oncology |Sanofi|Last Updated: May 4, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment879
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00305188Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.PHASE3 COMPLETED 879 — — Dec 1, 2005Oct 1, 2009May 4, 201613 United States, Argentina +11
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Study Endpoints
Primary Endpoints
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment
Q2W during treatment, Q4W to Q12W during post-treatment follow-up
Secondary Endpoints
Main: response rate using RECIST criteria
Q8W
Other: nerve conduction studies
baseline, end of treatment with oxaliplatin, end of treatment with study drug
Other: progression free survival and survival
Q8W and study period
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Xaliproden (SR57746A)EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
Xaliproden (SR57746A)DRUGoral administration
PlaceboDRUGoral administration
OxaliplatinDRUGIV administration
5-FluorouracilDRUGIV administration
LeucovorinDRUGIV administration
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: Main inclusion criteria : * Histologically or cytologically-proven metastatic cancer of the colon or rectum. * Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease). * Male or female aged \>18 years. * WHO Performance Status (PS) ...

Countries:United StatesArgentinaAustraliaBrazilCanadaChileGermanyHungaryItalyPolandPortugalSpainUnited Kingdom
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