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A Phase 2 Study of BGJ398 in Patients With Recurrent GBM
Phase 2 trial testing BGJ398 in Recurrent Glioblastoma or Other Glioma Subtypes in 26 participants. Completed in 3 October 2018.
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 9 December 2013 |
| Primary completion | 3 October 2018 |
| Estimated completion | 3 October 2018 |
| Sites | 17 locations across Netherlands, Belgium, Switzerland, Australia, United States, Spain |
Novartis Pharmaceuticals — full company profile →
18 and older, any sex, with Recurrent Glioblastoma or Other Glioma Subtypes. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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)
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 1.7 | 1.05 – 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
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 2 |
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 7 |
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 13 |
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 3 |
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 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
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 6.74 | 4.17 – 11.73 |
Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose interruptions, reductions and dose intensity, and evaluations of laboratory values
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 13 |
| Group | Value | 95% CI |
|---|---|---|
| BGJ398X | 4 |
Time frame: 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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Non Surg BGJ398 125 mg |
|---|---|---|
| Neurological decompensation | Nervous system disorders | — |
| Cataract | Eye disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| General physical health deterioration | General disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Dehydration | Metabolism and nutrition disorders | — |
| Hyperphosphataemia | Metabolism and nutrition disorders | — |
| Ataxia | Nervous system disorders | — |
| Epilepsy | Nervous system disorders | — |
| Hemiparesis | Nervous system disorders | — |
| Hydrocephalus | Nervous system disorders | — |
| Neurological symptom | Nervous system disorders | — |
| Seizure | Nervous system disorders | — |
| Cataract operation | Surgical and medical procedures | — |
| Reaction | System | Non Surg BGJ398 125 mg |
|---|---|---|
| Hyperphosphataemia | Metabolism and nutrition disorders | — |
| Fatigue | General disorders | — |
| Diarrhoea | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Headache | Nervous system disorders | — |
| Stomatitis | Gastrointestinal disorders | — |
| Decreased appetite | Metabolism and nutrition disorders | — |
| Hyperlipasaemia | Metabolism and nutrition disorders | — |
| Hypophosphataemia | Metabolism and nutrition disorders | — |
| Muscular weakness | Musculoskeletal and connective tissue disorders | — |
| Seizure | Nervous system disorders | — |
| Insomnia | Psychiatric disorders | — |
| Urinary incontinence | Renal and urinary disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Anaemia | Blood and lymphatic system disorders | — |
| Dry eye | Eye disorders | — |
| Gait disturbance | General disorders | — |
| Oedema peripheral | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Hyperglycaemia | Metabolism and nutrition disorders | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — |
| Aphasia | Nervous system disorders | — |
| Onycholysis | Skin and subcutaneous tissue disorders | — |
| Palmar-plantar erythrodysaesthesia syndrome | Skin and subcutaneous tissue disorders | — |
| Thrombocytopenia | Blood and lymphatic system disorders | — |
| Eyelid ptosis | Eye disorders | — |
| Asthenia | General disorders | — |
| Mucosal inflammation | General disorders | — |
| Conjunctivitis | Infections and infestations | — |
| Oral candidiasis | Infections and infestations | — |
| Fall | Injury, poisoning and procedural complications | — |
| Blood alkaline phosphatase increased | Investigations | — |
| Hyponatraemia | Metabolism and nutrition disorders | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — |
| Dizziness | Nervous system disorders | — |
Most-reported serious reactions: Neurological decompensation, Cataract, Vomiting, General physical health deterioration, Decreased appetite, Dehydration, Hyperphosphataemia, Ataxia.
Data from ClinicalTrials.gov NCT01975701 adverse events section.
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.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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