[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"h3-k27m\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:h3-k27m":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,54],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":53},"100483863","phase-3-onc201-in-h3-k27m-mutant-diffuse-glioma-following-radiotherapy-the-action-study-100483863",false,"NCT05580562","ONC201 in H3 K27M-mutant Diffuse Glioma Following Radiotherapy (the ACTION Study)","ONC201 for the Treatment of Newly Diagnosed H3 K27M-mutant Diffuse Glioma Following Completion of Radiotherapy: A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study","ACTION","Inclusion Criteria:\n\n1. Able to understand the study procedures and agree to participate in the study by providing written informed consent (by participant or legally authorized representative), and assent when applicable.\n2. Body weight ≥ 10 kg at time of randomization.\n3. Histologically diagnosed H3 K27M-mutant diffuse glioma (new diagnosis). Detection of a missense K27M mutation in any histone H3-encoding gene detected by testing of tumor tissue (immunohistochemistry \\[IHC\\] or next-generation sequencing \\[NGS\\] in a Clinical Laboratory Improvement Amendments \\[CLIA\\]-certified or equivalent laboratory). \\[Site to provide (as available): ≥ 11 unstained formalin-fixed paraffin-embedded (FFPE) slides from tumor tissue.\\]\n4. At least one, high-quality, contrast-enhanced MRI of the brain obtained prior to starting radiotherapy for submission to sponsor's imaging vendor for central read. For participants who had a surgical resection, this scan must be post-resection; for participants who did not have a resection, this scan may be pre- or post-biopsy.\n5. At least one, high-quality, contrast-enhanced MRI of the brain obtained 2 to 6 weeks after completion of frontline radiotherapy. If unable to obtain contrast-enhanced imaging due to lack of venous access after multiple attempts, a patient may still be eligible after collection of a nonenhanced MRI of the brain. \\[Site to also provide all available MRIs completed prior to initiating treatment with study intervention.\\]\n6. Received frontline radiotherapy\n\n   1. Initiated radiotherapy within 12 weeks from the initial diagnosis of H3 K27M-mutant diffuse glioma.\n   2. Completed radiotherapy within 2 to 6 weeks prior to randomization\n   3. Completed standard fractionated radiotherapy (eg. 54 to 60 Gy in 28 to 33 fractions given over approximately 6 weeks or hypofractionated radiotherapy (eg. 40 Gy in 15 fractions given over approximately 3 weeks).\n7. Karnofsky Performance Status or Lansky Performance Status ≥ 70 at time of randomization.\n8. Stable or decreasing dose of corticosteroids and anti-seizure medications for 7 days prior to randomization, if applicable. Stable steroid dose is defined as ≤ 2 mg\u002Fday increase (based on dexamethasone dose or equivalent dose of an alternative steroid).\n\nExclusion Criteria:\n\n1. Primary spinal tumor.\n2. Diffuse intrinsic pontine glioma (DIPG), defined as tumors with a pontine epicenter and diffuse involvement of the pons.\n3. Evidence of leptomeningeal spread of disease or cerebrospinal fluid dissemination.\n4. Any known concurrent malignancy.\n5. New lesion(s) outside of the radiation field.\n6. Received whole-brain radiotherapy.\n7. Received proton therapy for glioma.\n8. Use of any of the following treatments within the specified time periods prior to randomization:\n\n   1. Dordaviprone (ONC201) or ONC206 at any time.\n   2. Systemic bevacizumab (includes biosimilars) at any time since the initial diagnosis of H3 K27M-mutant diffuse glioma.\n   3. Temozolomide within past 3 weeks.\n   4. Tumor treating fields at any time.\n   5. DRD2 antagonist within past 2 weeks.\n   6. Any investigational therapy within past 4 weeks.\n   7. Strong CYP3A4 inhibitors within 3 days.\n   8. Strong CYP3A4 inducers (includes enzyme-inducing antiepileptic drugs) within 2 weeks.\n9. Laboratory test results meeting any of the following parameters within 2 weeks prior to randomization:\n\n   1. Absolute neutrophil count \\\u003C 1.0 × 109\u002FL or platelets \\\u003C 75 × 109\u002FL.\n   2. Total bilirubin \\> 1.5 × upper limit of normal (ULN) (participants with Gilbert's syndrome may be included with total bilirubin \\> 1.5 × ULN if direct bilirubin is ≤ 1.5 × ULN).\n   3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 × ULN.\n   4. Creatinine clearance ≤ 60 mL\u002Fmin as calculated by the Cockcroft Gault equation (or estimated glomerular filtration rate \\\u003C 60 mL\u002Fmin\u002F1.73 m2).\n10. QTc \\> 480 msec (based on mean from triplicate electrocardiograms) during screening.\n11. Known hypersensitivity to any excipients used in the study intervention formulation.\n12. Pregnant, breastfeeding, or planning to become pregnant while receiving study intervention or within 3 months after the last dose. Participants of childbearing potential must have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study intervention.\n13. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring systemic therapy or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n14. Any other condition (eg, medical, psychiatric, or social) that, in the opinion of the investigator, may interfere with participant safety or the ability to complete the study according to the protocol.","ALL",{"count":19,"type":20},510,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with dordaviprone (ONC201) following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.",[26,27],"H3 K27M","Glioma",[26,29,30,31,32,33,34,35,36,37,38,39,40],"H3 K28M","H3 K27-altered","histone","H3F3A","HIST1H3B","HIST1H3C","H3.1","H3.3","DMG","thalamus","thalamic","midline","RECRUITING","2026-04-13",{"date":44,"type":45},"2026-04-16","ACTUAL",{"date":47,"type":45},"2023-01-23",{"date":49,"type":20},"2028-06",{"name":51,"class":52},"Jazz Pharmaceuticals","INDUSTRY",162,{"id":55,"slug":56,"hasResults":11,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":4,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":17,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":21,"phases":66,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":88},"100512774","phase-1-treatment-of-relapsedrefractory-intracranial-glioma-in-patients-under-22-years-of-age-100512774","NCT05956821","Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","Phase I\u002FII Trial of Repeat Dosing of Super-Selective Intraarterial Infusion of Erbitux (Cetuximab) and Avastin (Bevacizumab) for Treatment of Relapsed\u002FRefractory Intracranial Glioma in Patients Under 22 Years of Age","Inclusion Criteria:\n\n* Documented histologic diagnosis of relapsed or refractory glioblastoma multiforme (GBM), anaplastic astrocytoma (AA), fibrillary astrocytomas (FA), pilomyxoid astrocytoma (PXA), oligodendroglioma, or anaplastic mixed oligoastrocytoma (AOA), or radiologically diagnosed diffuse intrinsic brainstem glioma (DIPG)\n* Must have at least one confirmed and evaluable tumor site\n* Must have a Karnofsky or Lansky performance status ≥60%.\n* No chemotherapy for three weeks prior to treatment\n* Patients must have adequate hematologic reserve with absolute neutrophils≥1000\u002Fmm3 and platelets ≥100,000\u002F mm3\n* Pre-enrollment chemistry parameters must show: bilirubin\\\u003C1.5x the institutional upper limit of normal (IUNL); Aspartate Aminotransferase( AST) or Alanine transaminase (ALT)\\\u003C2.5x IUNL and creatinine\\\u003C1.5x IUNL\n* Pre-enrollment coagulation parameters (PT and PTT) must be ≤1.5x the IUNL\n* Growth factor(s): Must not have received within 1 week of entry onto this study\n* Steroids: Systemic corticosteroid therapy is permissible in patients with Central Nervous System (CNS) tumors for treatment of increased intracranial pressure or symptomatic tumor edema. Patients with CNS tumors who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to study entry.\n* Patients of reproductive age must agree to use a medically effective method of contraception during and for a period of three months after the treatment period. A pregnancy test will be performed on each premenopausal female of childbearing potential immediately prior to entry into the research study\n* Patients or their parents\u002Fguardians must be able to understand and give written informed consent. Informed consent must be obtained at the time of patient screening\n* Because of known concerns with Avastin and wound healing, craniotomy patients are eligible for the treatment if they have had a craniotomy greater than two weeks prior to Intra-Arterial (IA) therapy. Craniotomy or major procedure after SIACI Avastin therapy should wait 4 weeks. Minor surgeries may be performed after two weeks\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating\n* Females of childbearing potential and fertile men will be informed as to the potential risk of procreation while participating in this research trial and will be advised that they must use effective contraception during and for a period of three months after the treatment period. If they do not agree, they will be ineligible for the study\n* Patients with significant concurrent medical or psychiatric conditions that would place them at increased risk or affect their ability to receive or comply with treatment or post-treatment clinical monitoring",true,"1 Year","21 Years",{"count":65,"type":20},20,[67,68],"PHASE1","PHASE2","This study assesses the safety and efficacy of repeat monthly dosing of super-selective intra-arterial cerebral infusion (SIACI) of cetuximab and bevacizumab in patients \\\u003C 22 years of age.",[71,72,73,74,75,76,77,26],"Glioblastoma Multiforme","Anaplastic Astrocytoma","Fibrillary Astrocytomas","Oligodendroglioma","Diffuse Intrinsic Brainstem Glioma","Diffuse Intrinsic Pontine Glioma","DIPG Brain Tumor","2025-12-04",{"date":80,"type":45},"2025-12-08",{"date":82,"type":45},"2025-06-19",{"date":84,"type":20},"2029-12-01",{"name":86,"class":87},"University of Miami","OTHER",1]