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SR57746A

Phase 3

Metastases | Small molecule | Oncology |Sanofi|Last Updated: Sep 13, 2006

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment620
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00272051XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV ChemotherapyPHASE3 COMPLETED 620Jul 1, 2002May 1, 2004Sep 13, 2006 -
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Study Endpoints
Primary Endpoints
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W
Secondary Endpoints
Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION
Interventions
NameTypeDescription
SR57746ADRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Histologically or cytologically proven adenocarcinoma of the colon or the rectum * age \> 18 years * WHO performance status : 0,1,2 * Signed written informed consent prior to study entry * Disease stage : metastatic disease not amenable to potentially curative treatment (eg : ...

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