Pediatric low-grade glioma harboring an activating RAF alteration requiring first-line systemic therapy
Conditions
Brief summary
ORR, per RAPNO criteria, defined as the proportion of patients with overall confirmed response of complete response (CR), partial response (PR), or minor response (MR).
Detailed description
PFS per RAPNO criteria, defined as time from randomization to progressive disease (PD) or death from any cause, whichever comes first., EFS per RAPNO criteria, defined as time from randomization to PD, death from any cause, or initiation of any new anticancer therapy, whichever comes first., OS, defined as time from randomization up to death from any cause.
Interventions
DRUGVELBE 10 mg Trockensubstanz zur Injektionsbereitung
DRUG2 mg
DRUGcellcristin® 1 mg/ml Injektionslösung Wirkstoff: Vincristinsulfat
DRUGVinblastinesulfaat 1 mg/ml PCH
DRUGoplossing voor injectie
DRUGVinblastin STADA 10 mg Pulver zur Herstellung einer Injektionslösung
DRUGTovorafenib
Sponsors
Day One Biopharmaceuticals Inc.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR, per RAPNO criteria, defined as the proportion of patients with overall confirmed response of complete response (CR), partial response (PR), or minor response (MR). | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS per RAPNO criteria, defined as time from randomization to progressive disease (PD) or death from any cause, whichever comes first., EFS per RAPNO criteria, defined as time from randomization to PD, death from any cause, or initiation of any new anticancer therapy, whichever comes first., OS, defined as time from randomization up to death from any cause. | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Norway, Slovenia, Spain, Sweden
Outcome results
None listed