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AZD3514

Phase 1

Prostate Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 12, 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
UNCONTROLLEDBiomarker
Total Trials2
Total Enrollment77
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01351688An Open Label Prostate Cancer Study in Japanese PatientsPHASE1 COMPLETED 13Aug 1, 2011May 1, 2013Jul 3, 20132 Japan
NCT01162395Open Label Prostate Cancer StudyPHASE1 COMPLETED 64Aug 1, 2010Oct 1, 2015Jan 12, 20165 United States, Netherlands +1
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Study Endpoints
Primary Endpoints
To investigate the safety and tolerability of AZD3514 when given orally to Japanese patients with castration resistant prostate cancer
All AEs will be collected throughout the study, from informed consent until 30 days after the end of study treatment. The total duration of this time frame can not be specified

Number of participants with adverse events

To investigate the safety and tolerability of AZD3514 when given orally to patients with CRPC.
At every visit.
Secondary Endpoints
To define the maximum tolerated dose, if possible, a lower biologically-effective dose(s) or maximum feasible dose of AZD3514
during the single dose period and the first 21 days of multiple dosing (ie, by study day 29)
To characterise the pharmacokinetics of AZD3514 after a single oral dose and at steady state after multiple oral doses
Multiple timepoints taken, begining at Day 1 and until 48 hrs after last dose. The total duration of this time frame can not be specified, as it depends on the number of treatments the subject may receive.
To obtain an preliminary assessment of the anti-tumour activity of AZD3514
Every 12 weeks
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AZD3514EXPERIMENTALAscending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
AEXPERIMENTALAscending doses of AZD3514 administered orally to patients to define the maximum tolerated dose (MTD)
Interventions
NameTypeDescription
AZD3514DRUGPatients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout.
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Eligibility Criteria
Age Range20 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Males aged 20 years or older. * Histologically or Cytologically proven diagnosis of prostate cancer for which no standard therapy is currently considered appropriate * Documented evidence of metastatic prostate cancer * Serum testosterone concentration ≤50 ng/dL * World Health...

Countries:JapanUnited StatesNetherlandsUnited Kingdom
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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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