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RAD001, Docetaxel, Bevacizumab

Phase 1

Prostate Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Apr 11, 2017

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 Enrollment27
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00574769Safety Study & Effectiveness of Docetaxel With RAD001 and Bevacizumab in Men With Advanced Prostate CancerPHASE1 COMPLETED 27Feb 17, 2010Feb 17, 2017Apr 11, 20172 United States
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Study Endpoints
Primary Endpoints
Establish a maximal tolerated or optimal biologic dose of RAD001 in combination with docetaxel/bevacizumab
After the last patient in the cohort has completed at least two cycles of RAD001/docetaxel/bevacizumab
Secondary Endpoints
Evaluate the efficacy of RAD001 in combination with docetaxel/bevacizumab as determined by best overall response and progression-free survival in patients with advanced prostate cancer.
overall survival
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
Interventions
NameTypeDescription
RAD001, Docetaxel, BevacizumabDRUGRAD001 oral, 2.5 mg daily RAD001 oral, 5mg daily Bevacizumab infusion (IV), 15 mg/kg every 21 days Docetaxel infusion (IV), 75 mg/m\^2 every 21 days
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Eligibility Criteria
Age Range18 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Age ≥ 18 years. * Signed informed consent * ECOG performance status: 0-2 * Histologically documented adenocarcinoma of the prostate * Progressive disease despite androgen deprivation therapy. Progressive disease is defined as any one of the following: * Measurable Disease: Obj...

Countries:United States
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Competitive Landscape -Prostate Cancer 259 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK7PHASE3Pembrolizumab, Enzalutamide, Ifinatamab deruxtecan, Docetaxel, Prednisone
AstraZeneca PLCAZN20PHASE3olaparib, abiraterone, Saruparib, Abiraterone, Darolutamide
Pfizer Inc.PFE12PHASE3Talazoparib with enzalutamide, PF-06821497, Docetaxel, Enzalutamide, Leuprolide Open Label
Johnson & JohnsonJNJ21PHASE3Apalutamide, Androgen Deprivation Therapy, Niraparib, Abiraterone, Prednisone
Eli Lilly and CompanyLLY9PHASE3Abemaciclib, Abiraterone, Prednisone or Prednisolone, -PNT2002, Enzalutamide
Amgen Inc.AMGN7PHASE3Xaluritamig, Abiraterone, Enzalutamide, Cabazitaxel, Docetaxel
Novartis AG Sponsored ADRNVS28PHASE3177Lu-PSMA-617, 68Ga-PSMA-11, ARDT, ADT, AAA617
Exelixis, Inc.EXEL4PHASE3Cabozantinib, Atezolizumab, Abiraterone, Enzalutamide, Prednisone
Candel Therapeutics, Inc.CADL3PHASE3Aglatimagene besadenovec + valacyclovir, aglatimagene besadenovec, valacyclovir, aglatimagene besadenovec + valacyclovir
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986365, Enzalutamide, Abiraterone, Docetaxel, Predinsone/Prednisolone
BioNTech SE Sponsored ADRBNTX1PHASE3BNT324, Docetaxel, Prednisone/prednisolone
Telix Pharmaceuticals Limited Sponsored ADRTLX3PHASE368Ga-PSMA-11, 177Lu-TLX591, Enzalutamide, Abiraterone, Docetaxel
Sanofi SA Sponsored ADRSNY2PHASE3abiraterone, Docetaxel, Cabazitaxel
Regeneron Pharmaceuticals, Inc.REGN4PHASE2REGN2810, Degarelix, Leuprolide, Docetaxel, BPX-601
Veracyte, Inc.VCYT2PHASE2Darolutamide, Zoladex, Zoladex LA, Decapeptyl sustained release, Depo-Eligard
Kyntra Bio, Inc.KYNB2PHASE2FG-3246, FOR46, Enzalutamide, Pegfilgrastim
Lantheus Holdings IncLNTH3PHASE3Undisclosed
IDEAYA Biosciences, Inc.IDYA3PHASE1IDE-161, Pembrolizumab, IDE034, IDE574, Fulvestrant
Xencor, Inc.XNCR1PHASE2vudalimab
GSK plc Sponsored ADRGSK2PHASE1GSK5471713, GSK5458514
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