progressive/relapsed/refractory pediatric low-grade glioma (pLGG)
Conditions
Brief summary
DLT of the combination treatment regimens, Best response (CR or PR) will be based on RAPNO-LGG criteria, defined for each patient as the best response under study treatment period (maximum 12 cycles) (assessment every 8 weeks) by central review.
Detailed description
Duration of Response (DOR) and Disease Control Rate (DCR), Adverse events according to Common Toxicity Criteria for Adverse Events (CTCAE) v5.0, PFS and OS, RR in the population that reaches MTD, Selection of promising arm(s) for further investigation by steering committee on the basis of the totality of data (activity, tolerability and functional outcome(s)), ORR2, DOR2, DCR2 and PFS2 after re-challenge for rebound tumor growth, MR based on RAPNO-LGG, TTR and time to best response, Comparison of best response between treatment arms, Ulixertinib and tovorafenib plasma PK
Interventions
Sponsors
Universitaetsklinikum Heidelberg AöR
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT of the combination treatment regimens, Best response (CR or PR) will be based on RAPNO-LGG criteria, defined for each patient as the best response under study treatment period (maximum 12 cycles) (assessment every 8 weeks) by central review. | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response (DOR) and Disease Control Rate (DCR), Adverse events according to Common Toxicity Criteria for Adverse Events (CTCAE) v5.0, PFS and OS, RR in the population that reaches MTD, Selection of promising arm(s) for further investigation by steering committee on the basis of the totality of data (activity, tolerability and functional outcome(s)), ORR2, DOR2, DCR2 and PFS2 after re-challenge for rebound tumor growth, MR based on RAPNO-LGG, TTR and time to best response, Comparison of best response between treatment arms, Ulixertinib and tovorafenib plasma PK | — |
Outcome results
None listed