Study of AEE788 in Patients With Recurrent/Relapse Glioblastoma Multiforme (GBM)
- Registration Number
- NCT00116376
- Lead Sponsor
- Novartis Pharmaceuticals
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- 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
- Peripheral neuropathy > grade 1
- Diarrhea > grade 1
- Gastrointestinal dysfunction
- Compromised cardiac function
- Concurrent severe and/or uncontrolled medical conditions
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AEE788 + non EIACD AEE788 - AEE788 + EIACD AEE788 -
- Primary Outcome Measures
Name Time Method Maximum tolerated dose 2 years Dose limiting toxicity 2 years
- Secondary Outcome Measures
Name Time Method Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels 2 years
Trial Locations
- Locations (4)
University of California at Los Angeles
🇺🇸Los Angeles, California, United States
The Brain Tumor Center at Duke, Duke University Medical Center
🇺🇸Box 3624 DUMC, Trent Drive, Durham, North Carolina, United States
University of Texas, MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States