Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGJ398 · 4 trials · 10 indications
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)
The dose escalation part of the study will be guided by a well-established statistical method/model to estimate the maximum tolerated dose(s) and/or the recommended dose for expansion (RDE). Safety(incidence and nature of DLTs), pharmacokinetic and pharmacodynamic data will guide dose escalation decisioins.
Maximum tolerated dose (MTD) and/or Recommended dose (RD) of single agent oral BGJ398
Incidence rate and category of dose-limiting toxicities will be tabulated for patients included in the dose escalation portion of the study, to establish the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RPTD). This will be calculated using an established statistical model, based on incidence of adverse events and serious adverse events, physical examinations, vital signs, electrocardiograms, and laboratory parameters
| Arm | Type | Description |
|---|---|---|
| BGJ398X | EXPERIMENTAL | To estimate anti-tumor efficacy of BGJ398 |
| Metastatic breast cancer | EXPERIMENTAL | Evaluation of safety and efficacy in patients with metastatic breast cancer whose tumors contain mutations to PIK3CA and alterations FGFR 1-3. |
| Solid tumor arm 1 | EXPERIMENTAL | Patients with solid tumors (except for colorectal cancer) whose tumors express mutations to PIK3CA. |
| Solid tumor arm 2 | EXPERIMENTAL | Patients with solid tumors (except for colorectal cancer) whose tumomrs express mutations to PIK3CA and alterations to FGFR 1-3 |
| Dose escalation | EXPERIMENTAL | To determine the MTD or RDE of the combination of BGJ398 with BYL719 in patients with advanced or metastastic solid tumors that express mutations to PIK3CA. |
| BGJ398 | EXPERIMENTAL | Eligible participants received oral BGJ398 once daily or twice daily. Patients may continue treatment with BGJ398 until the patient experiences unacceptable toxicity or progressive disease. |
| Name | Type | Description |
|---|---|---|
| BGJ398 | DRUG | Capsule for oral use. |
| BYL719 | DRUG | BYL719 will be administered orally once daily on each day of the 28-day cycle. |
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...
BGJ398 is an investigational small molecule being studied for the treatment of advanced solid tumors, including tumors with alterations of FGFR1, 2 and/or 3, and recurrent glioblastoma or other glioma subtypes. It is being developed by Novartis AG (NVS) and is currently in clinical development.
BGJ398 targets fibroblast growth factor receptors (FGFR), specifically alterations in FGFR1, FGFR2, and FGFR3. It is being studied in patients with advanced solid tumors that have these genetic alterations, as well as in recurrent glioblastoma.
BGJ398 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The drug is an investigational small molecule in the oncology therapeutic area.
BGJ398 has completed Phase 1 and Phase 2 clinical trials. The completed trials include a Phase 1 dose escalation study, a Phase 1 study in Asian patients, a Phase 1b combination trial, and a Phase 2 study in recurrent glioblastoma. It remains an investigational drug.
BGJ398 has been studied in four completed clinical trials: NCT01004224, a Phase 1 dose escalation study in advanced solid tumors; NCT01697605, a Phase 1 study in Asian patients; NCT01928459, a Phase 1b trial combining BGJ398 with BYL719; and NCT01975701, a Phase 2 study in recurrent glioblastoma.
BGJ398 is also known by the generic name infigratinib. It is an investigational small molecule FGFR inhibitor being developed by Novartis for the treatment of advanced solid tumors with FGFR alterations and recurrent glioblastoma.