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

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: June 28, 2005
Last updated: November 7, 2015
Last verified: November 2015
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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Dose limiting toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: January 2004
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AEE788 + non EIACD Drug: AEE788
Experimental: AEE788 + EIACD Drug: AEE788


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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00116376

United States, California
University of California at Los Angeles
Los Angeles, California, United States, 90095
University of California, San Francisco
San Francisco, 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
Houston, Texas, United States, 77030
Sponsors and Collaborators
Novartis Pharmaceuticals
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

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT00116376     History of Changes
Obsolete Identifiers: NCT00085215
Other Study ID Numbers: CAEE788A2103
Study First Received: June 28, 2005
Last Updated: November 7, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors processed this record on November 25, 2015