Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01975701 | A Phase 2 Study of BGJ398 in Patients With Recurrent GBM | PHASE2 | COMPLETED | 26 | — | — | Dec 9, 2013 | Oct 3, 2018 | Dec 4, 2019 | 17 | United States, Australia +4 |
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)
| Arm | Type | Description |
|---|---|---|
| BGJ398X | EXPERIMENTAL | To estimate anti-tumor efficacy of BGJ398 |
| Name | Type | Description |
|---|---|---|
| BGJ398 | DRUG | Capsule for oral use. |
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 mut...