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A Phase 2 Study of BGJ398 in Patients With Recurrent GBM

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01975701
First received: October 28, 2013
Last updated: October 4, 2016
Last verified: October 2016
  Purpose
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 Intervention Phase
Recurrent Glioblastoma or Other Glioma Subtypes
Drug: BGJ398
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • progression free survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Overall response rate [ Time Frame: 8 months after last patient last visit ] [ Designated as safety issue: No ]
    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 Overall Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator

  • Overall survival [ Time Frame: 8 months after LPLV ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 months after LPLV ] [ Designated as safety issue: Yes ]
    Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values


Enrollment: 22
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BGJ398X
To estimate anti-tumor efficacy of BGJ398
Drug: BGJ398
Capsule for oral use.

Detailed Description:
Patients will be enrolled in two groups. Group 1 will enroll patients who are not candidates for surgery. Group 2 will enroll patients who are surgical candidates. Patients from both groups will be evaluated for tumor response and progression by MRI every 8 weeks until disease progression or discontinuation from study using RANO criteria.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01975701

Locations
United States, California
University of California at Los Angeles Dept. of Neuro-Oncology
Los Angeles, California, United States, 90095
University of California San Francisco Dept of Onc.
San Francisco, California, United States, 94101
United States, Illinois
Northwestern University Robert H Lurie Comp Cancer Ctr
Chicago, Illinois, United States, 60611
United States, Massachusetts
Dana Farber Cancer Institute SC
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University Medical Center- New York Presbyterian Dept of Oncology
New York, New York, United States, 10032
United States, Ohio
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept of Onc.
Columbus, Ohio, United States, 43210
United States, Texas
Texas Oncology Midtown Texas Oncology
Dallas, Texas, United States, 75251
University of Texas/MD Anderson Cancer Center SC-3
Houston, Texas, United States, 77030-4009
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
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01975701     History of Changes
Other Study ID Numbers: CBGJ398X2201 
Study First Received: October 28, 2013
Last Updated: October 4, 2016
Health Authority: United States: Food and Drug Administration
Australia: Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
France: National Agency for the Safety of Medicine and Health Products
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Medicines Evaluation Board
Italy: Italian Medicines Agency
Spain: Spanish Agency for Medicines and Health Products
Switzerland: Swiss Agency for Therapeutic Products
Sweden: Medical Products Agency

Keywords provided by Novartis:
BGJ398,
recurrent glioblastoma'
recurrent GBM,
FGFR,

Additional relevant MeSH terms:
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on December 02, 2016