[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Bożenna Dembowska Bagińska\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100659571","phase-1-study-of-cdk8-inhibitor-rvu120-in-combination-with-everolimus-in-children-with-recurrent-or-progressive-group-3-or-4-medulloblastoma-100659571",false,"NCT07865130","Study of CDK8 Inhibitor RVU120 in Combination With Everolimus in Children With Recurrent or Progressive Group 3 or 4 Medulloblastoma","Phase I Study of CDK8 Inhibitor RVU120 in Combination With Everolimus in Children With Recurrent or Progressive Group 3 or 4 Medulloblastoma","MEDWAY","Inclusion Criteria:\n\n* Diagnosis: Recurrent\u002Fprogressive Group 3 or Group 4 medulloblastoma confirmed by CLIA-certified methylation testing. Patients ≥4 years at initial diagnosis must have received CSI + systemic chemotherapy; patients \\\u003C4 years must have received systemic chemotherapy (CSI not required).\n* Age: 3 to ≤18 years.\n* Ability to swallow capsules\u002Ftablets required.\n* BSA: 0.4-2.5 m².\n* Disease status: Metastatic disease allowed. Phase 1 cohorts: measurable disease not required; patients post-GTR ± reirradiation, isolated LM disease, or positive CSF cytology eligible. Patients post-reirradiation may enroll after required washout. Expansion cohort: measurable disease per RAPNO required.\n* Prior therapy: Recovery from acute toxicities to ≤CTCAE v5.0 Grade 1. Required washouts: - Myelosuppressive chemo ≥21 days (≥42 days for nitrosoureas) - Biologic agents ≥7 days (long-lasting AEs: extended) - Monoclonal antibodies ≥28 days - Radiation: CSI\u002FTBI\u002F≥50% pelvis ≥42 days; focal RT ≥14 days - Autologous transplant ≥6 months - Growth factors ≥7 days (PEG ≥14 days)\n* Organ function: Adequate marrow, liver, and renal function per protocol thresholds. Neurologic status: Stable deficits ≥1 week; seizures controlled; no enzyme-inducing anticonvulsants.\n* Performance: KPS\u002FLPS ≥60. Wheelchair-mobile patients considered ambulatory.\n* Pregnancy prevention: Effective contraception required.\n* Consent: Ability to understand and sign informed consent\u002Fassent.\n\nExclusion Criteria:\n\n* Pregnancy\u002Flactation - Pregnant or lactating patients. Negative serum pregnancy test required for patients of childbearing potential.\n* Clinically significant illness - Serious uncontrolled infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction that may increase risk or interfere with study procedures. Includes prior\u002Fconcurrent malignancies that may affect safety or efficacy assessment.\n* Concurrent therapy: any anticancer or investigational therapy; corticosteroids allowed only if stable or decreasing ≥7 days; strong CYP1A2\u002FCYP3A4\u002F3A5 inducers\u002Finhibitors or P-gp inhibitors; prohibited fruits (grapefruit, Seville oranges, starfruit). Must be discontinued ≥7 days or ≥5 half-lives; hypersensitivity to RVU120, everolimus, or rapamycin derivatives; live virus vaccine \\\u003C21 days before enrollment (everolimus); hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption.\n* Recent major surgery - Major surgery including tumor biopsy \\\u003C14 days before enrollment. Minor neurosurgical procedures (VP shunt, cyst fenestration, central line placement) allowed.\n* Malabsorption - Conditions requiring supplementation or significant bowel\u002Fstomach resection preventing adequate RVU120 absorption.\n* Prior CDK8 or mTOR inhibitors - Prior therapy with CDK8 inhibitors or mTOR inhibitors (everolimus, sirolimus, temsirolimus).\n* Inability to comply - Patients unable or unwilling to adhere to study visits, assessments, drug administration, or required restrictions.","ALL","3 Years","18 Years",{"count":21,"type":22},48,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","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.",[28,29],"Medulloblastoma Recurrent","Medulloblastoma",[31],"recurrent or progressive G3 or G4 medulloblastoma","NOT_YET_RECRUITING","2026-10-02",{"date":35,"type":36},"2026-10-08","ACTUAL",{"date":38,"type":22},"2026-09",{"date":40,"type":22},"2033-06",{"name":42,"class":43},"Bożenna Dembowska Bagińska","OTHER",""]