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ARRY-380, HER2 inhibitor;

Phase 1

Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: May 7, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00650572A Study of ARRY-380 in Patients With Advanced HER2+ CancerPHASE1 COMPLETED 50May 1, 2008Mar 1, 2013May 7, 20204 United States, Canada
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Study Endpoints
Primary Endpoints
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Part 1, one year; Part 2, one year
Establish the maximum tolerated dose (MTD) of the study drug.
Part 1, one year
Characterize the pharmacokinetics of the study drug.
Part 2, one year
Assess amplification/expression of HER2 in archival and tumor tissues.
Part 2, one year
Secondary Endpoints
Characterize the pharmacokinetics of the study drug.
Part 1, one year
Assess changes in tumor markers.
Part 1, one year
Assess the efficacy of study drug in terms of tumor response and duration of response.
Part 1, one year; Part 2, one year
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-380EXPERIMENTAL -
Interventions
NameTypeDescription
ARRY-380, HER2 inhibitor; oralDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Key Inclusion Criteria (Part 1 and Part 2): * Histological or cytological evidence of HER2+ cancer (Part 1) or HER2+ metastatic breast cancer (Part 2). * Patients should have received at least one previous therapeutic regimen and either no longer are candidates for standard therapy, have no standar...

Countries:United StatesCanada
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