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ARRY-438162 , MEK inhibitor;

Phase 1

Advanced Solid Tumors | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 16, 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 Enrollment93
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00959127A Study of ARRY-438162 (MEK162) in Patients With Advanced CancerPHASE1 COMPLETED 93 — — Aug 1, 2009Jan 1, 2013Sep 16, 202010 United States
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Study Endpoints
Primary Endpoints
Establish the maximum tolerated dose (MTD) of the study drug.
Part 1, one year
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Parts 1, 2 and 3: two years
Characterize the pharmacokinetics (PK) of the study drug and metabolite.
Parts 1, 2 and 3: two years
Secondary Endpoints
Assess the efficacy of the study drug in terms of tumor response, duration of response, duration of stable disease, progression-free survival and overall survival.
Parts 1, 2 and 3: two years
Assess possible PK/pharmacodynamic (PD) or PK/efficacy and safety correlations.
Parts 1, 2 and 3: two years
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-438162 (MEK 162)EXPERIMENTAL -
Interventions
NameTypeDescription
ARRY-438162 (MEK162), MEK inhibitor; oralDRUGPart 1: multiple dose, escalating; Part 2: multiple dose, single schedule; Part 3: multiple dose, single schedule.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion Criteria (for Part 3): * A histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma which is metastatic (measurable disease). * Documented KRAS- or BRAF- tumor mutation. * Previously treated with or unsuitable for treatment with 5-Fluorouracil (5-FU), oxaliplat...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials
CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK2PHASE2pembrolizumab, V503, GARDASIL
Incyte CorporationINCY1PHASE2Chemotherapy, Retifanlimab
Novartis AG Sponsored ADRNVS1PHASE1KFA115, pembrolizumab
Iovance Biotherapeutics IncIOVA2PHASE2E7 TCR-T cells, Aldesleukin
AstraZeneca PLCAZN1 — Trastuzumab deruxtecan
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