Glioblastoma
Conditions
Brief summary
Safety endpoints: Incidence of adverse Events (AEs), Serious Adverse Events (SAEs) and Drug-Induced Liver Injury (DILI), standard labor-atory assessments, ECG, ECHO and physical examination ac-cording to CTCAE v.5.0, Efficacy endpoint: Survival rate at 12 months
Detailed description
Progression-Free Survival (PFS), Overall Survival (OS), Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), Incidence of Dose Reductions, Incidence of Dose Modifications, Pharmacokinetic parameters of L19TNF, Assessment of the formation of Human Anti-Fusion protein Antibodies (HAFA) against L19TNF
Interventions
DRUGLomustine "medac" 40 mg
DRUGFibromun
Sponsors
Philogen S.p.A.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints: Incidence of adverse Events (AEs), Serious Adverse Events (SAEs) and Drug-Induced Liver Injury (DILI), standard labor-atory assessments, ECG, ECHO and physical examination ac-cording to CTCAE v.5.0, Efficacy endpoint: Survival rate at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS), Overall Survival (OS), Objective Response Rate (ORR), Disease Control Rate (DCR), Duration of Response (DoR), Incidence of Dose Reductions, Incidence of Dose Modifications, Pharmacokinetic parameters of L19TNF, Assessment of the formation of Human Anti-Fusion protein Antibodies (HAFA) against L19TNF | — |
Countries
Germany, Italy
Outcome results
None listed