A Phase 2 interventional study of BGJ398 in Recurrent Glioblastoma or Other Glioma Subtypes, sponsored by Novartis Pharmaceuticals. Completed at 17 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-04.
Sponsored by Novartis Pharmaceuticals · Phase 2, Interventional, and Treatment
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.
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.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 26 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
To estimate anti-tumor efficacy of BGJ398
Drug: BGJ398
Capsule for oral use.
Progression Free Survival
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)
Time frame: 6 months
Overall Response Rate
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 Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator
Time frame: 5 years
Overall Survival
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
Time frame: 5 years
Safety and Tolerability
Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values
Time frame: 5 years
All 26 patients included were enrolled in the non-Surgical group, and were treated with BGJ398 125 mg once daily in 28-day cycles, on a 3 weeks on/1 week off schedule (dosing days 1 to 21 of every 28-day cycle). No patients were enrolled in the surgical group.
| Milestone | BGJ398X |
|---|---|
| Started | 26 |
| Completed | 1 |
| Not completed | 25 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Death | 23 |
| Withdrew: Physician decision | 1 |
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)
| months | BGJ398X |
|---|---|
| Progression Free Survival | 1.7 (1.05 to 2.80) |
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 Objective Response Rate (ORR - patients with measurable disease - as defined by RANO criteria as assessed by the investigator
| Participants | BGJ398X |
|---|---|
| partial response | 2 |
| stable disease | 7 |
| progressive disease | 13 |
| unknown | 3 |
| missing | 1 |
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
| months | BGJ398X |
|---|---|
| Overall Survival | 6.74 (4.17 to 11.73) |
Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values
| Participants | BGJ398X |
|---|---|
| participants with dose interruptions | 13 |
| participants with dose reductions | 4 |
Collected over All AEs reported in this record are treatment emergent AEs, collected from date of First Patient First Treatment until the completion of the safety follow-up ( 30 days after the Last Patient Last Treatment ) up to approximately 5 years.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Non Surg BGJ398 125 mg | 3/26 (11.5%) | 9/26 (34.6%) | 26/26 (100%) |
| Event | Non Surg BGJ398 125 mg |
|---|---|
| Neurological decompensationNervous system disorders | 2/26 |
| CataractEye disorders | 1/26 |
| VomitingGastrointestinal disorders | 1/26 |
| General physical health deteriorationGeneral disorders | 1/26 |
| Decreased appetiteMetabolism and nutrition disorders | 1/26 |
| DehydrationMetabolism and nutrition disorders | 1/26 |
| HyperphosphataemiaMetabolism and nutrition disorders | 1/26 |
| AtaxiaNervous system disorders | 1/26 |
| EpilepsyNervous system disorders | 1/26 |
| HemiparesisNervous system disorders | 1/26 |
| Event | Non Surg BGJ398 125 mg |
|---|---|
| HyperphosphataemiaMetabolism and nutrition disorders | 20/26 |
| FatigueGeneral disorders | 9/26 |
| DiarrhoeaGastrointestinal disorders | 8/26 |
| ConstipationGastrointestinal disorders | 7/26 |
| DyspepsiaGastrointestinal disorders | 7/26 |
| HeadacheNervous system disorders | 6/26 |
| StomatitisGastrointestinal disorders | 5/26 |
| Decreased appetiteMetabolism and nutrition disorders | 4/26 |
| HyperlipasaemiaMetabolism and nutrition disorders | 4/26 |
| HypophosphataemiaMetabolism and nutrition disorders | 4/26 |
| Age, Continuous(years) | BGJ398X |
|---|---|
| Mean | 53.7 ± 13.59 |
| Sex: Female, Male(Participants) | BGJ398X |
|---|---|
| Female | 10 |
| Male | 16 |
| Race/Ethnicity, Customized(Participants) | BGJ398X |
|---|---|
| caucasian | 26 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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