A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Completed · Phase 2

Conditions studied: Recurrent Glioblastoma or Other Glioma Subtypes

In brief

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.

Key facts

Study ID

NCT01975701

Run by

Novartis Pharmaceuticals

People needed

26

Starts

2013-12-09

Expected to finish

2018-10-03

Last updated by the study team

2019-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically confirmed GBM and/or other glioma subtypes at the time of diagnosis or prior relapse.
• 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
• RANO defined tumor progression by MRI in comparison to a prior scan
• Patients must have received prior external beam radiotherapy and temozolomide.

You may not qualify if…

• History of another primary malignancy
• Prior or current treatment with a FGFR inhibitor
• Neurological symptoms related to underlying disease requiring increasing doses of corticosteroids
• 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.

Where it is running

• Novartis Investigative Site — Los Angeles, California, United States
• University of California San Francisco Dept of Onc. — San Francisco, California, United States
• Novartis Investigative Site — Chicago, Illinois, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — New York, New York, United States
• Novartis Investigative Site — Columbus, Ohio, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Dallas, Texas, United States
• Novartis Investigative Site — Houston, Texas, United States
• Novartis Investigative Site — Melbourne, Victoria, Australia
• Novartis Investigative Site — Leuven, Belgium
• University Medical Center Utrecht — Utrecht, The Netherlands, Netherlands
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — L'Hospitalet de Llobregat, Catalonia, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Zurich, Switzerland

Full record on ClinicalTrials.gov

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