A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

NCT01975701 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CBGJ398X2201
• Study Type: interventional
• Target: 26
• Locations: 6 countries
• Sites: 17

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.

Conditions

Recurrent Glioblastoma or Other Glioma Subtypes

Keywords

BGJ398,; recurrent glioblastoma'; recurrent GBM,; FGFR,

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall Response Rate

  5 years

• Overall Survival

  5 years

• Safety and Tolerability

  5 years

Study Arms (1)

BGJ398X

EXPERIMENTAL

To estimate anti-tumor efficacy of BGJ398

Drug: BGJ398

Interventions

BGJ398 DRUG

Capsule for oral use.

BGJ398X

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Novartis Investigative Site

Los Angeles, California, 90095, United States

Location

University of California San Francisco Dept of Onc.

San Francisco, California, 94101, United States

Location

Novartis Investigative Site

Chicago, Illinois, 60611, United States

Location

Novartis Investigative Site

Boston, Massachusetts, 02215, United States

Location

Novartis Investigative Site

New York, New York, 10032, United States

Location

Novartis Investigative Site

Columbus, Ohio, 43221, United States

Location

Novartis Investigative Site

Dallas, Texas, 75246, United States

Location

Novartis Investigative Site

Dallas, Texas, 75251, United States

Location

Novartis Investigative Site

Houston, Texas, 77030, United States

Location

Novartis Investigative Site

Melbourne, Victoria, 3050, Australia

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

University Medical Center Utrecht

Utrecht, The Netherlands, 3508 GA, Netherlands

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

L'Hospitalet de Llobregat, Catalonia, 08907, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 28050, Spain

Location

Novartis Investigative Site

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

infigratinib

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Limitations and Caveats

BGJ398 was out licensed and the indication was no longer pursued. Remaining patient continued treatment in post-trial settings.

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novatis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2013
• First Posted: November 5, 2013
• Study Start: December 9, 2013
• Primary Completion: October 3, 2018
• Study Completion: October 3, 2018
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-11

Locations

ES (4); US (9); BE (1); NL (1); CH (1); AU (1)