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

This study has been completed.

First Received: June 28, 2005 Last Updated: July 5, 2007 History of Changes

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00116376

Purpose

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.

Condition	Intervention	Phase
Glioblastoma Multiforme	Drug: AEE788	Phase I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study
Official Title:	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

Further study details as provided by Novartis:

Primary Outcome Measures:

Maximum tolerated dose
Dose limiting toxicity

Secondary Outcome Measures:

Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels

Estimated Enrollment:	64
Study Start Date:	November 2003
Estimated Study Completion Date:	March 2007

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00116376

Locations

United States, California
University of California at Los Angeles
710 Westwood Plaza, Suite 1-230, Los Angeles, California, United States, 90095
University of California, San Francisco
400 Parnassus Avenue, Rm A808, California, United States, 94143
United States, North Carolina
The Brain Tumor Center at Duke, Duke University Medical Center
Box 3624 DUMC, Trent Drive, Durham, North Carolina, United States, 27710
United States, Texas
University of Texas, MD Anderson Cancer Center
1515 Holcombe Blvd, Houson, Texas, United States, 77030

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:	David Reardon, MD	Duke University
Principal Investigator:	Charles Conrad, MD	M.D. Anderson Cancer Center
Principal Investigator:	Timothy Cloughesy, MD	University of California, Los Angeles
Principal Investigator:	Michael Prados, MD	University of California, San Francisco

More Information

No publications provided

Study ID Numbers:	CAEE788A2103
Study First Received:	June 28, 2005
Last Updated:	July 5, 2007
ClinicalTrials.gov Identifier:	NCT00116376 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Novartis:

GBM
recurrent/relapse
EGFR
VEGFR

Study placed in the following topic categories:

Neuroectodermal Tumors
Glioblastoma
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioblastoma Multiforme
Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Glioblastoma
Neoplasms
Neoplasms by Histologic Type
Astrocytoma

Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009