A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

Phase 2

Completed

• Conditions: Recurrent Glioblastoma or Other Glioma Subtypes
• Interventions: Drug: BGJ398

• Registration Number: NCT01975701
• Lead Sponsor: Novartis Pharmaceuticals

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2013-10-28
• Study First Submitted QC: 2013-11-04
• Study First Posted: 2013-11-05
• Study Start: 2013-12-09
• Disposition First Submitted: 2018-09-06
• Primary Completion: 2018-10-03
• Study Completion: 2018-10-03
• Disposition First Submitted QC: 2019-03-22
• Disposition First Posted: 2019-03-28
• Results First Submitted: 2019-10-02
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-14
• Last Update Submitted: 2019-11-14
• Results First Posted: 2019-12-04
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BGJ398X	BGJ398	To estimate anti-tumor efficacy of BGJ398

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	5 years	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
Overall Survival	5 years	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
Safety and Tolerability	5 years	Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values

Trial Locations

Locations (3)

University of California San Francisco Dept of Onc.; 🇺🇸 San Francisco, California, United States

Novartis Investigative Site; 🇨🇭 Zürich, Switzerland

University Medical Center Utrecht; 🇳🇱 Utrecht, The Netherlands, Netherlands