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ARRY-142886, MEK inhibitor;

Phase 1

Advanced Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Oct 14, 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 Enrollment57
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00085787A Study of ARRY-142886 in Patients With Advanced CancerPHASE1 COMPLETED 57Jun 1, 2004Feb 1, 2007Oct 14, 20203 United States
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Study Endpoints
Primary Endpoints
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Part 1
Establish the maximum tolerated dose (MTD) of study drug.
Part 1
Assess the biological activity of the study drug in tumors in terms of inhibition of extracellular signal-regulated kinase (ERK) phosphorylation.
Part 2
Secondary Endpoints
Characterize the pharmacokinetics (PK) of the study drug in terms of plasma concentrations.
Part 1 and Part 2
Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.
Part 1 and Part 2
Assess the efficacy of the study drug in terms of tumor dimension assessment.
Part 1 and Part 2
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-142886EXPERIMENTAL -
Interventions
NameTypeDescription
ARRY-142886, MEK inhibitor; oralDRUGPart 1: single dose and multiple dose, escalating; Part 2: multiple dose, single schedule
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Key Inclusion Criteria (Part 2): * Histopathologically or cytologically confirmed solid tumor that is refractory to standard therapies, or for which no standard therapies exist, or for which the Investigator feels no other active therapy is required for the duration of the study. * Eastern Cooperat...

Countries:United States
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