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BMS-599626

Phase 1

HER2 or EGFR Expressing Advanced Solid Malignancies | Small molecule | Other |Bristol-Myers Squibb Company|Last Updated: Mar 2, 2010

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 Enrollment45
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00207012MAD Refractory: Solid Tumor QD w/o BreakPHASE1 COMPLETED 45May 1, 2004 -Mar 2, 20102 France, Spain
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Study Endpoints
Primary Endpoints
Determine the maximum tolerated, biologically active doses and recommended phase 2 dose(s) of BMS-599-626 when administered as a daily uninterrupted oral dose
Secondary Endpoints
Efficacy (Best Clinical Response)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
BMS-599626DRUG -
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Signed written informed consent * Available for periodic follow-up * Life expectancy of at least 3 months * ECOG performance status score 0-1 * Histologic or cytologic diagnosis of a primary malignancy of breast, ovarian, bladder, gastric, non small cell lung or colon origin *...

Countries:FranceSpain
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