A Phase 2 Study of BGJ398 in Patients With Recurrent GBM



Status:Completed
Conditions:Brain Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:December 9, 2013
End Date:October 3, 2018

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A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma

This is an open-label non-randomized, multicenter, phase II study of BGJ398 administered to
adult patients with histologically confirmed GBM and/or other glioma subtypes with
FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3.

Patients will be enrolled in two groups. Group 1 will enroll patients who are not candidates
for surgery. Group 2 will enroll patients who are surgical candidates. Patients from both
groups will be evaluated for tumor response and progression by MRI every 8 weeks until
disease progression or discontinuation from study using RANO criteria.

Inclusion criteria:

1. Patients with histologically confirmed GBM and/or other glioma subtypes at the time of
diagnosis or prior relapse.

2. Written documentation of local or central laboratory determination of amplification or
translocation to FGFR1-TACC1, FGFR3-TACC-3 fusion and/or activating mutation in FGFR1,
FGFR2,or FGFR3

3. RANO defined tumor progression by MRI in comparison to a prior scan

4. Patients must have received prior external beam radiotherapy and temozolomide.

Exclusion criteria:

1. History of another primary malignancy

2. Prior or current treatment with a FGFR inhibitor

3. Neurological symptoms related to underlying disease requiring increasing doses of
corticosteroids

4. Patients must not be taking Enzyme Inducing Anti-Epileptic Drug (EIAED). If previously
on an EIAED, the patient must be off of it for at least two weeks prior to study
treatment.
We found this trial at
9
sites
Boston, Massachusetts 02118
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Chicago, Illinois 60612
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Chicago, IL
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Columbus, Ohio 43205
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Columbus, OH
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Dallas, Texas 75216
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Dallas, TX
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Houston, Texas 77030
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Houston, TX
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Los Angeles, California 90095
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Los Angeles, CA
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Melbourne, Victoria
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Melbourne,
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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New York, NY
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San Francisco, California 94101
Principal Investigator: Nicolas Butowski
Phone: 415-353-2523
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San Francisco, CA
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