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

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.

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