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

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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