E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
recurrent resectable or unresectable Glioblastoma |
recidief operabel of niet operabel glioblastoma |
|
E.1.1.1 | Medical condition in easily understood language |
Recurrent primary brain cancer |
Teruggekeerde primaire hersentumor |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2,or 3, based on PFS6. |
Om de anti-tumor activiteit van BGJ398 te onderzoeken bij patienten met GBM en/of andere glioom subtype met een FGFR1-TACC1, FGFR3-TACC3 fusie en/of activerende mutatie van FGFR1,2 of 3, gebaseerd op progressie-vrije overleving na 6 maanden. |
|
E.2.2 | Secondary objectives of the trial |
1) To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2,or 3, based on Overall Response Rate (ORR)
2) To further assess the anti-tumor activity of BGJ398 for patients with GBM and/or other glioma subtypes with FGFR1-TACC1, FGFR3-TACC3 fusion and/or activating mutation in FGFR1,2, or 3, based on Overall Survival
3) Safety: type, frequency, and severity of AEs and SAEs; Tolerability: dose
interruptions, reductions and dose intensity, and evaluations of laboratory values |
1) Om de anti-tumor activiteit van BGJ398 verder te onderzoeken bij patienten met GBM en/of andere glioom subtype met een FGFR1-TACC1, FGFR3-TACC3 fusie en/of activerende mutatie van FGFR1,2 of 3 gebaseerd op algemene repons ratio.
2) Om de anti-tumor activiteit van BGJ398 verder te onderzoeken bij patienten met GBM en/of andere glioom subtype met een FGFR1-TACC1, FGFR3-TACC3 fusie en/of activerende mutatie van FGFR1,2 of 3 gebaseerd op algehele overleving.
3) Veiligheid: soort, frequentie, en ernst van AEs en SAEs; Verdraagbaarheid: doeseringstakingen, dosisverlagingen en dosisintensiteit, evaluatie van labwaarden |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1)Patients with histologically confirmed GBM and/or glioma subtypes at the time of diagnosis or prior relapse.
2) Documentation of FGFR1-TACC1, FGFR3-TACC3 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.
Other protocol defined criteria may apply |
1)Patienten met een histologisch bevestigde GBM en/of andere glioom subtype ten tijde van diagnose of voorafgaande recidive.
2) Documentatie van FGFR1-TACC1, FGFR3-TACC3 fusie en/of activerende mutatie van FGFR1, FGFR2 of FGFR3.
3) RANO gedefinieerde tumorprogressie vastgesteld middels MRI in vergeleken met een voorafgaande scan
4) Patienten dienen voorafgaande uitwendige radiotherapie en temozolomide te hebben gehad.
Andere inclusiecriteria welke in het protocol gedefinieerd zijn, kunnen van toepassing zijn. |
|
E.4 | Principal 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.
Other protocol defined criteria may apply |
1) Andere primaire maligniteit in het verleden
2) Voorafgaande of actuele behandeling met een FGFR remmer
3) Neurologische symptomen gerelateerd aan onderliggende ziekte welke toenemende doses corticosteroiden behoeven
4) Patienten mogen geen Enzyme Inducing Anti-Epileptic Drug (EIAED) gebruiken. Wanneer de patient voorafgaand een EIAED gebruikte, dient de patient minstens 2 weken voor start studiemedicatie met het gebruik gestopt te zijn.
Andere exclusiecriteria welke in het protocol gedefinieerd zijn, kunnen van toepassing zijn. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
progression free survival |
Progressie-vrije overleving |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
1) Overall response rate
2) Overall survival
3) safety and tolerability |
1) Algemene respons ratio
2) Algehele overleving
3) Veiligehid en verdraagbaarheid |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 8 months after LVLS (last visit last subject)
2) 8 months after LVLS
3) continuous |
1) 8 maanden na LVLS
2) 8 maanden na LVLS
3) continuerend |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 6 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belgium |
Italy |
Netherlands |
Spain |
Switzerland |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
End of study will be upon completion of the follow up period for the last patient treated. This will be either upon study completion of the last patient treated or once the last patient has expired or all patients have completed the study and have been followed for at least one year after their first dose of study treatment, have been lost to follow-up, or withdrew consent, whichever occurs first. |
De afronding vindt plaats als een van volgende citeria voldaan is: laatste deelnemer rondt de studie af; laatste deelnemer overlijdt voor afronding deelname; alle deelnemers hebben de studie afgerond en zijn op zijn minst gedurende een jaar na de eerste toediening van de studiemedicatie vervolgd; alle patienten zijn verloren voor follow-up; alle patienten hebben hun deelname ingetrokken. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |