Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)

A Phase I/II, Two-arm, Multicenter, Dose Escalation Study of Oral AEE788 Administered on a Continuous Once Daily Dosing Schedule in Adult Patients With Recurrent or Relapsing Glioblastoma Multiforme

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00116376

Enrollment

Registered

2005-06-29

Start date

2004-01-31

Completion date

2005-11-30

Last updated

2015-11-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

GBM, recurrent/relapse, EGFR, VEGFR

Brief summary

AEE788 is an orally active, reversible, small-molecule, multi-targeted kinase inhibitor with potent inhibitory activity against the ErbB and VEGF receptor family of tyrosine kinases. It has an IC50 of less than 100 nM against p-EGFR, p-ErbB2, and p-KDR (VEGFR2). This study will assess the safety, pharmacokinetic/pharmacodynamic (PK/PD) profiles and clinical activity of AEE788 in a recurrent GBM population.

Interventions

DRUGAEE788

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 \> grade 1 * Gastrointestinal dysfunction * Compromised cardiac function * Concurrent severe and/or uncontrolled medical conditions

Design outcomes

Primary

Measure	Time frame
Maximum tolerated dose	2 years
Dose limiting toxicity	2 years

Secondary

Measure	Time frame
Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026