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SAR405838

Phase 1

Neoplasm Malignant | Small molecule | Oncology |Sanofi|Last Updated: May 17, 2018

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 Trials2
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01985191A Safety and Efficacy Study of SAR405838 and Pimasertib in Cancer PatientsPHASE1 COMPLETED 26 — — Nov 1, 2013Feb 1, 2016Feb 25, 20164 France, Netherlands
NCT01636479Phase 1 Safety Testing of SAR405838PHASE1 COMPLETED 77 — — Jul 13, 2012Mar 5, 2018May 17, 20187 United States, France +1
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Study Endpoints
Primary Endpoints
SAR405838 (pimasertib) RP2D assessed by dose-limiting toxicities and pharmacological activities
6 weeks for each patient at each dose level
Changes of tumor dimension by imaging
At least 3 months for each patient
SAR405838 Maximum tolerated dose (MTD)
Cycle 1 (21 days) or 2 Cycles (42 days) dependent on dosing schedule
In MTD cohort, clinical benefit
Until disease progression
Secondary Endpoints
Overall safety profile of SAR405838 (pimasertib), number of participants with adverse events
Throughout the study
Pharmacokinetic parameters for both SAR405838 (pimasertib): the maximum concentration in blood (Cmax)
3 months for each patient
Pharmacokinetic parameters for both SAR405838 (pimasertib): time to the maximum concentration (Tmax)
3 months for each patient
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm 1EXPERIMENTALSAR405838 and pimasertib in escalating doses
SAR405838EXPERIMENTALSAR405838 in escalating doses
Interventions
NameTypeDescription
SAR405838DRUGPharmaceutical form:capsule Route of administration: oral
PimasertibDRUGPharmaceutical form: capsule Route of administration: oral
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion criteria: * Histologically or cytologically confirmed diagnosis of a solid tumor. * Presence of locally advanced or metastatic disease with at least one measurable lesion. * Ability to provide written informed consent. Evidence of a personally signed informed consent. Exclusion criteria:...

Countries:FranceNetherlandsUnited States
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