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INCB007839

Phase 1

Solid Tumors and Hematologic Malignancy | Small molecule | Oncology |Incyte Corporation|Last Updated: Jan 17, 2018

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment41
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00820560Open-Label Study to Assess the Safety/Tolerability in Patients With Solid TumorsPHASE1 COMPLETED 41 — — Jan 1, 2005Jan 1, 2009Jan 17, 20184 United States
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Study Endpoints
Primary Endpoints
Identify a maximum tolerable dose as measured through adverse event reporting, ECGs and laboratory assessments
Baseline through study completion
Secondary Endpoints
Evaluation of response rates as measured by RECIST criteria
At Screening, Day 1 of all 28 day cycles beginning of each subsequent odd numbered cycle.
Evaluation of PSA laboratory values for response
Baseline and every visit through study termination
Evaluation of PD markers for HER2 and ErbB ligand levels
Measured at screening and Day 1 of all subsequent 28 days cycles and Day 15 of Cycle 1.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
INCB07839 100mg, immediate release (IR) capsulesEXPERIMENTAL -
INCB07839 200 mg IR capsulesEXPERIMENTAL -
Interventions
NameTypeDescription
INCB007839DRUGINCB007839 100 or 200 mg/dose as IR capsules
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Either non-small cell lung cancer, hormone-refractory prostate cancer, colorectal cancer, breast cancer, or squamous cell cancer of the head and neck that is refractory to standard treatment or for which no effective treatment exists. The patient must have a life expectancy of...

Countries:United States
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