A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Study Overview
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Brief Summary
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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.

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

Conditions
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Recurrent Glioblastoma or Other Glioma Subtypes

Intervention / Treatment
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* Drug: BGJ398


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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. Exclusion criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BGJ398X<br>To estimate anti-tumor efficacy of BGJ398 | Drug: BGJ398<br>* Capsule for oral use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 or 3 based on PFS6 (PFS rate at 6 months as defined by RANO criteria as assessed by the investigator) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | To further assess the anti-tumor activity of BGJ398 for patients with GBM with an amplification, translocation, or activating mutation in FGFR1,2,3 or 4, based on Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator | 5 years | 
| Overall Survival | To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes that harbor FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1, 2 and 3 based on Overall Survival | 5 years | 
| Safety and Tolerability | Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BGJ398,, recurrent glioblastoma', recurrent GBM,, FGFR,