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AEE788

Phase 1

Brain and Central Nervous System Tumors | Small molecule | Oncology |Novartis AG|Trials Updated: Nov 10, 2015

AEE788 development status

Highest phase Phase 1
Registered trials 3 across 1 sponsor since Apr 2005

AEE788 target and mechanism

Molecular targetEGFR, ERBB2, FLT1, KDR
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials3
Total Enrollment269

FDA Designations

No designations recorded

AEE788 clinical trials

AEE788 · 3 trials · 3 indications

Phase 1 3
NCT00116376Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)Glioblastoma Multiforme
COMPLETED64 Analytics
NCT00107237AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma MultiformeBrain and Central Nervous System Tumors
COMPLETED16 Analytics
NCT00118456Study of Oral AEE788 in Adults With Advanced CancerCancer
COMPLETED189 Analytics
PHASE1COMPLETED
Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)
Glioblastoma MultiformeUnlock trial analytics
PHASE1COMPLETED
AEE788 and Everolimus in Treating Patients With Recurrent or Relapsed Glioblastoma Multiforme
Brain and Central Nervous System TumorsUnlock trial analytics
PHASE1COMPLETED
Study of Oral AEE788 in Adults With Advanced Cancer
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose
2 years
Dose limiting toxicity
2 years
Maximum tolerated dose and dose-limiting toxicity of AEE788
Maximum-tolerated dose and dose-limiting toxicity of AEE788
4.5 years
Maximum-tolerated dose, safety and tolerability of AEE788
4.5 years

Secondary Endpoints

Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels
2 years
Safety
Tolerability
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEE788 + non EIACDEXPERIMENTAL -
AEE788 + EIACDEXPERIMENTAL -
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
1EXPERIMENTALContinuous daily dosing
2EXPERIMENTALMonday, Wednesday, Friday Dosing

Interventions

NameTypeDescription
AEE788DRUG -
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 to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * Histologically confirmed GBM in first or second recurrence or relapse * Adequate hematologic, hepatic and renal function * Age ≥ 18 years * Karnofsky performance status score ≥ 70% * Life expectancy ≥ 12 weeks Exclusion Criteria: * Peripheral neuropathy \> grade 1 * Diarrhea...

Countries:United States
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Frequently asked questions about AEE788

What is AEE788?

AEE788 is an investigational oral small molecule developed by Novartis AG (ticker NVS) for the treatment of cancer. It has been studied in adults with advanced solid tumors and in patients with glioblastoma multiforme and other brain and central nervous system tumors. It remains in Phase 1 clinical development.

What does AEE788 target?

AEE788 is an inhibitor of EGFR, ERBB2, FLT1 and KDR. By inhibiting these receptor tyrosine kinases, it is designed to interfere with signaling pathways involved in tumor cell growth and blood vessel formation. It is a small molecule administered orally.

Who makes AEE788?

AEE788 is developed by Novartis AG, which trades under the ticker NVS. Novartis sponsored the Phase 1 clinical trials of AEE788 conducted in the United States in adults with advanced cancer and glioblastoma multiforme.

What phase is AEE788 in?

AEE788 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. All three recorded trials of AEE788 are Phase 1 studies and all have completed, with no active trials currently listed.

What clinical trials is AEE788 in?

AEE788 has been evaluated in three completed Phase 1 trials: NCT00118456 in adults with advanced cancer, NCT00116376 in patients with recurrent or relapsed glioblastoma multiforme, and NCT00107237 combining AEE788 with everolimus in recurrent or relapsed glioblastoma multiforme. All were conducted in the United States.

What is AEE788 used for in glioblastoma multiforme?

AEE788 has been studied in Phase 1 trials as a treatment for recurrent or relapsed glioblastoma multiforme, including one study combining it with everolimus. These trials enrolled adults aged 18 years and older. AEE788 is investigational and is not an approved therapy for glioblastoma multiforme.