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A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01975701
Recruitment Status : Completed
First Posted : November 5, 2013
Results First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( 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.

Condition or disease Intervention/treatment Phase
Recurrent Glioblastoma or Other Glioma Subtypes Drug: BGJ398 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
Actual Study Start Date : December 9, 2013
Actual Primary Completion Date : October 3, 2018
Actual Study Completion Date : October 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BGJ398X
To estimate anti-tumor efficacy of BGJ398
Drug: BGJ398
Capsule for oral use.




Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 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 :
  1. Overall Response Rate [ Time Frame: 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

  2. Overall Survival [ Time Frame: 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

  3. Safety and Tolerability [ Time Frame: 5 years ]
    Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  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.

Exclusion criteria:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01975701


Locations
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United States, California
Novartis Investigative Site
Los Angeles, California, United States, 90095
University of California San Francisco Dept of Onc.
San Francisco, California, United States, 94101
United States, Illinois
Novartis Investigative Site
Chicago, Illinois, United States, 60611
United States, Massachusetts
Novartis Investigative Site
Boston, Massachusetts, United States, 02215
United States, New York
Novartis Investigative Site
New York, New York, United States, 10032
United States, Ohio
Novartis Investigative Site
Columbus, Ohio, United States, 43221
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75246
Novartis Investigative Site
Dallas, Texas, United States, 75251
Novartis Investigative Site
Houston, Texas, United States, 77030
Australia, Victoria
Novartis Investigative Site
Melbourne, Victoria, Australia, 3050
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Netherlands
University Medical Center Utrecht
Utrecht, The Netherlands, Netherlands, 3508 GA
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Hospitalet de LLobregat, Catalunya, Spain, 08907
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28050
Switzerland
Novartis Investigative Site
Zürich, Switzerland, 8091
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] December 21, 2017
Study Protocol  [PDF] April 1, 2015

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01975701    
Other Study ID Numbers: CBGJ398X2201
First Posted: November 5, 2013    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: December 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
BGJ398,
recurrent glioblastoma'
recurrent GBM,
FGFR,
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue