Completed

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

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What is being tested

BGJ398

Drug
Who is being recruted

Astrocytoma+7

+ Glioblastoma

+ Glioma

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 2013
See protocol details

Summary

Principal SponsorNovartis Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 9, 2013

Actual date on which the first participant was enrolled.

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

Official TitleA Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
NCT01975701
Principal SponsorNovartis Pharmaceuticals
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AstrocytomaGlioblastomaGliomaNeoplasmsNeoplasms by Histologic TypeNeoplasms, Germ Cell and EmbryonalNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueNeuroectodermal TumorsNeoplasms, Neuroepithelial

Criteria

4 inclusion criteria required to participate
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.
4 exclusion criteria prevent from participating
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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
To estimate anti-tumor efficacy of BGJ398

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 17 locations

Suspended

Novartis Investigative Site

Los Angeles, United StatesOpen Novartis Investigative Site in Google Maps
Suspended

University of California San Francisco Dept of Onc.

San Francisco, United States
Suspended

Novartis Investigative Site

Chicago, United States
Suspended

Novartis Investigative Site

Boston, United States
Completed17 Study Centers