Phase 1Not yet recruiting
Study of CDK8 Inhibitor RVU120 in Combination With Everolimus in Children With Recurrent or Progressive Group 3 or 4 Medulloblastoma (MEDWAY)
Phase I Study of CDK8 Inhibitor RVU120 in Combination With Everolimus in Children With Recurrent or Progressive Group 3 or 4 Medulloblastoma
- Sponsor
- Bożenna Dembowska Bagińska (Academic or other)
- Enrolment
- 48 planned
- Conditions
- Medulloblastoma Recurrent; Medulloblastoma
- Interventions
- RVU120; Everolimus (Afinitor) tablets
- Ages
- children, adults
- Registry
- NCT07865130
Full record on ClinicalTrials.gov
From the registry
This study will determine the safety and tolerability of RVU120 as a single agent and in combination with the mTOR inhibitor everolimus in children with recurrent or progressive G3 or G4 medulloblastoma and provide preliminary data regarding the efficacy of this treatment approach.
Primary outcomes
- Frequency and nature of AEs, SAEs and DLTs according to CTCAE v5.0 in RVU120 monotherapy and combination therapy with everolimus
- MTD and/or RP2D of RVU120 as a single agent and in combination with everolimus
History
Primary completion expected
Registered
Started