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AUY922 /m2

Phase 1

Breast Cancer | Small molecule | Oncology |Novartis AG|Last Updated: Dec 17, 2020

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 Enrollment117
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00526045Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer PatientsPHASE1 COMPLETED 117Jul 1, 2007Apr 1, 2012Dec 17, 202010 United States, Netherlands +2
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Study Endpoints
Primary Endpoints
The safe dose of AUY922 when administered once a week
54 weeks (MTD determination)
Secondary Endpoints
Efficacy of AUY922 administered once a week
Baseline, and every 2 cycles (time to document tumor progression)
Pharmacokinetics of AUY922 and Pharmacodynamics by PET response, blood and tumor biomarkers at baseline and post-AUY922
Baseline and every 2 cycles
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
EscalationEXPERIMENTAL -
HER2 PositiveEXPERIMENTAL -
ER+ breast cancerEXPERIMENTAL -
Interventions
NameTypeDescription
AUY922 2 mg/m2DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Dose-escalation and MTD dose expansion arm: Patients with histologically confirmed, advanced malignant solid tumors whose disease has progressed on standard therapy or for whom no standard therapy exists. Breast cancer phase II expansion arms only: 1. Females patients ...

Countries:United StatesNetherlandsSwitzerlandUnited Kingdom
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Competitive Landscape -Breast Cancer 408 trials
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