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XL765

Phase 1

Glioblastoma | Small molecule | Oncology |Sanofi|Last Updated: Jul 27, 2012

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01240460Exploratory Study of XL765 (SAR245409) or XL147 (SAR245408) in Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical ResectionPHASE1 COMPLETED 40 — — Jan 1, 2011Jun 1, 2012Jul 27, 20124 United States
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Study Endpoints
Primary Endpoints
To explore the biological effect of XL765 and XL147 measured by modulation of PI3K/ mTOR pathway readouts in GB tumor tissue
Assessed between 10 and 28 days after initiation of study drug
Secondary Endpoints
To examine the safety profile of daily oral administration of XL765 and XL147 in subjects with recurrent GB
Assessed at every visit to the study clinic for the duration of subject's treatment
To determine the levels of XL765 and XL147 in plasma and GB tumor tissue
Assessed at periodic visits between 10 and 28 days after initiation of study drug for the duration of subject's treatment
To assess the anti-proliferative and pro-apoptotic effects of XL765 and XL147 on tumor cells
Assessed at periodic visits to the study clinic for the duration of subject's treatment
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALTwice-daily dosing (every 12 hours) XL765
2EXPERIMENTALOnce-daily dosing XL147
3EXPERIMENTALOnce-daily dosing XL765
Interventions
NameTypeDescription
XL765 (SAR245409)DRUGSupplied as 10-mg and/or 50-mg capsules
XL147 (SAR245408)DRUGSupplied as 100-mg, 150-mg and/or 200-mg tablets
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. The subject has histologically confirmed diagnosis of primary GB for which the subject has received prior treatment, including radiation and/or chemotherapy, and will be undergoing a second surgical resection. 2. The subject has available archival tumor tissue from the time o...

Countries:United States
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