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ARRY-382, cFMS inhibitor;

Phase 1

Metastatic Cancer | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Sep 21, 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 Enrollment26
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01316822A Study of ARRY-382 in Patients With Selected Advanced or Metastatic CancersPHASE1 COMPLETED 26Mar 1, 2011Oct 1, 2012Sep 21, 20202 United States
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Study Endpoints
Primary Endpoints
Characterize the safety profile of the study drug as determined by adverse events, clinical laboratory tests and electrocardiograms.
Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Establish the maximum tolerated dose (MTD) of study drug.
The MTD will be based on Cycle 1 (28 days).
Characterize the plasma pharmacokinetics (PK) of study drug and its metabolites.
Safety will be characterized for the duration of time that each patient stays on study; estimated one year.
Secondary Endpoints
Assess the efficacy of study drug in terms of incidence of response rate and duration of response.
All patients will remain on study until progression of disease, unacceptable toxicity, or another discontinuation criterion is met; estimated one year.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ARRY-382EXPERIMENTAL -
Interventions
NameTypeDescription
ARRY-382, cFMS inhibitor; oralDRUGmultiple dose, escalating
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Key Inclusion Criteria: * A histologically or cytologically confirmed diagnosis of advanced or metastatic solid cancer refractory to standard treatment, for which no standard therapy is available or for which the patient refuses standard therapy. * Measurable disease or evaluable, nonmeasurable dis...

Countries:United States
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