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CompletedNCT00116376Updated Nov 10, 2015

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

A Phase 1/2 interventional study of AEE788 in Glioblastoma Multiforme, sponsored by Novartis Pharmaceuticals. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-11-10.

Sponsored by Novartis Pharmaceuticals · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
64
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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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.

02

Conditions studied

  • Glioblastoma Multiforme

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Keywords

  • GBM
  • recurrent/relapse
  • EGFR
  • VEGFR
03

In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's enrollment of 64 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Exclusion Criteria:

  • Peripheral neuropathy > grade 1
  • Diarrhea > grade 1
  • Gastrointestinal dysfunction
  • Compromised cardiac function
  • Concurrent severe and/or uncontrolled medical conditions
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    AEE788 + non EIACD

    Drug: AEE788

  • Experimental
    AEE788 + EIACD

    Drug: AEE788

Interventions

  • DrugAEE788
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What researchers measure

Primary outcomes

  1. Maximum tolerated dose

    Time frame: 2 years

  2. Dose limiting toxicity

    Time frame: 2 years

Secondary outcomes

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

    Time frame: 2 years

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Study locations

4 sites
  • University of California at Los Angeles
    Los Angeles, California 90095, United States
  • University of California, San Francisco
    San Francisco, California 94143, United States
  • The Brain Tumor Center at Duke, Duke University Medical Center
    Box 3624 DUMC, Trent Drive, Durham, North Carolina 27710, United States
  • University of Texas, MD Anderson Cancer Center
    Houston, Texas 77030, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00116376
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Jun 29, 2005
Start date
Jan 2004
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Nov 10, 2015

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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