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AEE788

Phase 1

Brain and Central Nervous System Tumors | Small molecule | Oncology |Novartis AG|Last Updated: Jun 12, 2013

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 Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00107237AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma MultiformePHASE1 COMPLETED 16Oct 1, 2003Jun 1, 2006Jun 12, 20133 United States
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Study Endpoints
Primary Endpoints
Maximum tolerated dose and dose-limiting toxicity of AEE788
Secondary Endpoints
Safety
Tolerability
Single-dose and repeated-dose pharmacokinetic profile
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEE788 200 mg + RAD001 5 mgEXPERIMENTALAEE788 200 mg qd, RAD001 5 mg qd
AEE788 150 mg + RAD001 5mgEXPERIMENTALAEE788 150 mg qd, RAD001 5 mg qod
Interventions
NameTypeDescription
AEE788DRUGAEE788 was available in the form of a hard gelatin capsule of 50 mg or 100 mg strengths and packaged in bottles.
everolimusDRUGEverolimus was formulated as tablets of 2.5 mg and 5 mg strength and supplied in blister packs.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

DISEASE CHARACTERISTICS: * Histologically confirmed glioblastoma multiforme, meeting 1 of the following criteria: * Phase I * In first or second recurrence or relapse * At least 1 measurable or evaluable enhancing lesion by gadolinium MRI (Gd-MRI) of the brain within the past 3 weeks ...

Countries:United States
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