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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Details

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.

Keywords

Recurrent Glioblastoma or Other Glioma Subtypes BGJ398, recurrent glioblastoma' recurrent GBM, FGFR, Glioblastoma

Eligibility

You can join if…

Open to people ages 18 years and up

  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.

You CAN'T join if...

  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.

Locations

  • University of California San Francisco Dept of Onc.
    San Francisco, California, 94101, United States
  • University of California at Los Angeles Dept. of Neuro-Oncology
    Los Angeles, California, 90095, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
ID
NCT01975701
Phase
Phase 2
Lead Scientist
Nicholas Butowski
Study Type
Interventional
Last Updated
November 2, 2017