Clinical trial NCT01975701: A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
Official title: A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Recurrent Glioblastoma or Other Glioma Subtypes
Keywords: BGJ398,
recurrent glioblastoma'
recurrent GBM,
FGFR,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-11-05
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Progression Free Survival
timeFrame: 6 months
Secondary outcomes:
measure: Overall Response Rate
timeFrame: 5 years
measure: Overall Survival
timeFrame: 5 years
measure: Safety and Tolerability
timeFrame: 5 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Novartis Investigative Site
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Dept of Onc.
state: California
city: Chicago
country: United States
facility: Novartis Investigative Site
state: Illinois
city: Boston
country: United States
facility: Novartis Investigative Site
state: Massachusetts
city: New York
country: United States
facility: Novartis Investigative Site
state: New York
city: Columbus
country: United States
facility: Novartis Investigative Site
state: Ohio
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Dallas
country: United States
facility: Novartis Investigative Site
state: Texas
city: Houston
country: United States
facility: Novartis Investigative Site
state: Texas
city: Melbourne
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Leuven
country: Belgium
facility: Novartis Investigative Site
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
state: The Netherlands
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Hospitalet de LLobregat
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Zürich
country: Switzerland
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: