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

Last updated: November 7, 2015
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

1/2

Condition

Gliomas

Astrocytoma

Glioblastoma Multiforme

Treatment

N/A

Clinical Study ID

NCT00116376
CAEE788A2103
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Peripheral neuropathy > grade 1

  • Diarrhea > grade 1

  • Gastrointestinal dysfunction

  • Compromised cardiac function

  • Concurrent severe and/or uncontrolled medical conditions

Study Design

Total Participants: 64
Study Start date:
January 01, 2004
Estimated Completion Date:
November 30, 2005

Connect with a study center

  • University of California, San Francisco

    400 Parnassus Avenue, Rm A808, California 94143
    United States

    Site Not Available

  • University of California at Los Angeles

    710 Westwood Plaza, Suite 1-230, Los Angeles, California 90095
    United States

    Site Not Available

  • University of California at Los Angeles

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Site Not Available

  • The Brain Tumor Center at Duke, Duke University Medical Center

    Box 3624 DUMC, Trent Drive, Durham, North Carolina 27710
    United States

    Site Not Available

  • University of Texas, MD Anderson Cancer Center

    1515 Holcombe Blvd, Houson, Texas 77030
    United States

    Site Not Available

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

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