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 |
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.
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.
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
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Francisco, California 94101
Principal Investigator: Nicolas Butowski
Phone: 415-353-2523
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