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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00116376
First Posted: June 29, 2005
Last Update Posted: November 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  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 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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 ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Maximum tolerated dose [ Time Frame: 2 years ]
  • Dose limiting toxicity [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • Safety, tolerability, pharmacokinetic profiles, change in plasma markers of angiogenesis, tumor PK levels [ Time Frame: 2 years ]

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

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00116376


Locations
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
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

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00116376     History of Changes
Obsolete Identifiers: NCT00085215
Other Study ID Numbers: CAEE788A2103
First Submitted: June 28, 2005
First Posted: June 29, 2005
Last Update Posted: November 10, 2015
Last Verified: November 2015

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
GBM
recurrent/relapse
EGFR
VEGFR

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue