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

Status:	Completed
Conditions:	Brain Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	January 2004
End Date:	November 2005

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

We found this trial at

sites

University of Texas M.D. Anderson Cancer Center

1515 Holcombe Blvd
Houston, Texas 77030

713-792-2121