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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00116376
First received: June 28, 2005
Last updated: December 22, 2009
Last verified: December 2009
History of Changes
  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
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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
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

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, San Francisco
400 Parnassus Avenue, Rm A808, California, United States, 94143
University of California at Los Angeles
710 Westwood Plaza, Suite 1-230, Los Angeles, California, United States, 90095
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 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

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00116376     History of Changes
Obsolete Identifiers: NCT00085215
Other Study ID Numbers: CAEE788A2103
Study First Received: June 28, 2005
Last Updated: December 22, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on May 23, 2013