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AMG 102 at /kg

Phase 2

Advanced Malignant Glioma | Small molecule | Oncology |Amgen Inc.|Last Updated: Apr 27, 2015

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment61
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00427440A Phase II Study to Treat Advanced Malignant GliomaPHASE2 COMPLETED 61Nov 1, 2006Apr 1, 2013Apr 27, 2015 -
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Study Endpoints
Primary Endpoints
Assess best objective confirmed response rate in subjects with advanced malignant glioma receiving AMG 102 treatment
Week 9 from first dose of AMG 102
Secondary Endpoints
To assess the safety profile of AMG 102 in subjects with advanced malignant glioma
entire study
Estimate overall survival and progression-free survival rates in this population
8 week intervals
Assess the duration of response and time to response in this population
Treatment Period
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AMG 102 at 10 mg/kg Dose LevelEXPERIMENTALUp to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
AMG 102 at 20 mg/kg Dose LevelEXPERIMENTALUp to 40 subjects will be treated at this dose level based upon investigator assessment of responses observed.
Interventions
NameTypeDescription
AMG 102 at 20 mg/kgDRUGAMG 102 at 20 mg/kg IV (in the vein) every 2 weeks
AMG 102 at 10 mg/kgDRUGAMG 102 at 10 mg/kg IV (in the vein) every 2 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: * subjects with documented histologically confirmed primary grade 4 advanced malignant glioma * no more than 3 prior relapses or prior systemic treatments * recurrent disease documented by MRI after prior therapy * must have at least one site of bidimensionally measurable diseas...

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