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panHer

Phase 1

Cancer | Small molecule | Oncology |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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00095537BMS-599626 in Patients With Advanced Solid MalignanciesPHASE1 COMPLETED 60Mar 1, 2004 -Mar 2, 20103 United States
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Study Endpoints
Primary Endpoints
Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy
Secondary Endpoints
Evaluate the effect of BMS-599626 on biomarkers & predictive markers of HER1/2 in skin metabolic act. through PET imaging & preliminary evidence of anti-tumor act.,determine the effect of gastric acid modifying agents on systemic exposure of BMS-599626
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Phase 1 MTD StudyEXPERIMENTAL -
Interventions
NameTypeDescription
panHerDRUGTablets, Oral, A modified Fibonocci dose escalation system initiated at 100mg and escalating up to 880mg maximum dose (rounded down to 20mg increments based on smallest tablet size); -2 40mg -33%; -1 60mg -40%; 1 100mg --; 2 200mg 100%; 3 320mg 67%; 4 480mg 50%; 5 660mg 40%; 6 880mg 33.3%, Daily, Until DLT or study MTD is reached.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Diagnosis of metastatic cancer that has progressed on currently available therapies; * At least 3 month life expectancy; * Primary cancer must be solid (non-hematologic); * Adequate bone marrow, liver \& kidney function; * Negative pregnancy test. Exclusion Criteria: * Serio...

Countries:United States
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