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

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Glioblastoma Multiforme

Treatments: Drug: AEE788

Study type: Interventional

Funder types: Industry

Identifiers

NCT00116376

CAEE788A2103

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

AEE788 + non EIACD

Experimental group

Treatment:

Drug: AEE788

AEE788 + EIACD

Experimental group

Treatment:

Drug: AEE788