Recent Updates
Recently added Catalysts

AEE788

Phase 1

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

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Clinical trial landscape

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
Unlock Study Endpoints

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.
Unlock Study Design Details

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
Unlock Eligibility Criteria

Frequently asked questions about AEE788

What is AEE788 used for?

AEE788 is an investigational small molecule being studied for the treatment of brain and central nervous system tumors, glioblastoma multiforme, and advanced cancer. It was evaluated in Phase 1 clinical trials in patients with recurrent or relapsed glioblastoma multiforme and in adults with advanced cancer.

Who makes AEE788?

AEE788 is being developed by Novartis AG, which trades under the ticker symbol NVS. The company sponsored Phase 1 clinical trials of the drug in the United States.

What phase is AEE788 in?

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

What clinical trials is AEE788 in?

AEE788 has been studied in three completed Phase 1 trials: NCT00107237, which tested AEE788 with everolimus in recurrent or relapsed glioblastoma multiforme; NCT00116376, which tested AEE788 alone in recurrent or relapsed glioblastoma multiforme; and NCT00118456, which tested oral AEE788 in adults with advanced cancer.

How does AEE788 work?

AEE788 is a small molecule that targets receptor tyrosine kinases involved in tumor growth and angiogenesis. By inhibiting these kinases, it is designed to block signaling pathways that promote cancer cell proliferation and survival.