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XL147

Phase 2

Endometrial Cancer | Small molecule | Oncology |Sanofi|Last Updated: Jun 3, 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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment67
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01013324Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial CarcinomaPHASE2 COMPLETED 67Jan 1, 2010Mar 1, 2013Jun 3, 201613 United States, Belgium
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Study Endpoints
Primary Endpoints
Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months
every 8-10 weeks
Safety of XL147 in the EC population
scheduled evaluations every 2-4 weeks
Secondary Endpoints
Duration of response and PFS
every 8-10 weeks
Characterize pharmacokinetic and pharmacodynamic profiles of XL147
at periodic visits not less than every 4 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single ArmEXPERIMENTALAll subjects will receive single-agent XL147 dosed daily
Interventions
NameTypeDescription
XL147 (SAR245408)DRUGdosed as capsules taken orally daily
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * The subject has a histologically confirmed diagnosis of EC (endometrioid, serous, clear cell adenocarcinoma, adenosquamous carcinoma, or mixed histology, any grade) that is advanced (ie, persistent, locally advanced) or recurrent, and is incurable by standard therapies and has...

Countries:United StatesBelgium
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Competitive Landscape -Endometrial Cancer 113 trials
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Gilead Sciences, Inc.GILD2PHASE3Sacituzumab govitecan-hziy, Doxorubicin, Paclitaxel
GSK plc Sponsored ADRGSK3PHASE3Mocertatug rezetecan, Paclitaxel, Doxorubicin, Dostarlimab, Carboplatin
BioNTech SE Sponsored ADRBNTX1PHASE3BNT323/DB-1303, Doxorubicin, Paclitaxel, Docetaxel
Genmab A/S Sponsored ADRGMAB3PHASE3Rina-S, IC, GEN1047 is a bispecific antibody that induces T-cell mediated cytotoxicity of B7H4-positive tumor cells., Carboplatin, Bevacizumab
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Xencor, Inc.XNCR2PHASE2vudalimab, XmAb541
Acrivon Therapeutics, Inc.ACRV1PHASE2ACR-368, Gemcitabine
MacroGenics, Inc.MGNX2PHASE2Lorigerlimab, MGC026 Dose Escalation
Iovance Biotherapeutics IncIOVA1PHASE2Lifileucel
Regeneron Pharmaceuticals, Inc.REGN2PHASE1REGN5668, Cemiplimab, Ubamatamab, Sarilumab, Tocilizumab
IDEAYA Biosciences, Inc.IDYA2PHASE1IDE-161, Pembrolizumab, IDE034
Bristol-Myers Squibb CompanyBMY1PHASE1BMS-986463
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