Medulloblastoma (recurrent or progressive)
Conditions
Brief summary
1. Frequency and nature of AEs, SAEs and DLTs according to CTCAE v5.0 in RVU120 monotherapy and combination therapy with everolimus 2. MTD and/or RP2D of RVU120 as a single agent and in combination with everolimus
Detailed description
1. PK parameters of RVU120 as a single agent and in combination with everolimus, including Cmax, AUCτ, tmax, AUC0 - ∞, t1/2 2. Ctrough of everolimus in combination with RVU120 3. Overall response rate (ORR), duration of response, progression-free survival (PFS), and overall survival (OS) in accordance with RAPNO guidelines, where applicable, stratified by molecular subgroup (G3 vs. G4) and MYC or MYCN expression in combination therapy of RVU120 and everolimus
Interventions
Sponsors
Instytut Pomnik Centrum Zdrowia Dziecka
Eligibility
Sex/Gender
All
Age
0 Years to 17 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Frequency and nature of AEs, SAEs and DLTs according to CTCAE v5.0 in RVU120 monotherapy and combination therapy with everolimus 2. MTD and/or RP2D of RVU120 as a single agent and in combination with everolimus | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. PK parameters of RVU120 as a single agent and in combination with everolimus, including Cmax, AUCτ, tmax, AUC0 - ∞, t1/2 2. Ctrough of everolimus in combination with RVU120 3. Overall response rate (ORR), duration of response, progression-free survival (PFS), and overall survival (OS) in accordance with RAPNO guidelines, where applicable, stratified by molecular subgroup (G3 vs. G4) and MYC or MYCN expression in combination therapy of RVU120 and everolimus | — |
Outcome results
None listed