Clinical trial · Interventional
A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
A Phase 2, Multicenter, Open-label Study of BGJ398 in Patients With Recurrent Resectable or Unresectable Glioblastoma
NCT01975701CI-TRIAL-00042057completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Glioblastoma or Other Glioma Subtypes | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BGJ398 | Drug | Infigratinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BGJ398X
- description
- To estimate anti-tumor efficacy of BGJ398
- interventionNames
- Drug: BGJ398
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- 6 months
- description
- 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 outcomes (3)
- measure
- Overall Response Rate
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.