[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idh-mutant-gliomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idh-mutant-gliomas":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100647673","phase-3-safety-and-efficacy-study-of-safusidenib-in-participants-with-grade-2-idh1-mutant-glioma-100647673",false,"NCT07712757","Safety and Efficacy Study of Safusidenib in Participants With Grade 2 IDH1-Mutant Glioma","A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Safusidenib in Participants With Grade 2 Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","Key Inclusion Criteria:\n\n* Expected survival of ≥12 months.\n* At least 1 prior surgery for glioma (biopsy, sub-total resection, or gross total resection), with the most recent surgery having occurred at least 90 days (or at least 28 days if biopsy only and postoperative changes have resolved per BICR) and no longer than 5 years before the date of randomization\n* Have not had any other prior anticancer therapy, including chemotherapy and radiotherapy; and are not in need of immediate chemotherapy or radiotherapy in the opinion of the Investigator.\n* Histologically confirmed Grade 2, IDH1-mutant oligodendroglioma or astrocytoma according to World Health Organization Central Nervous System 2021 classification criteria per Investigator assessment.\n* IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL), identified by polymerase chain reaction, next-generation sequencing (NGS), or immunohistochemistry; and confirmed 1p19q codeletion status by fluorescence in situ hybridization, NGS, or array comparative genomic hybridization.\n* Residual or recurrent, measurable, non-enhancing disease, as confirmed by BICR per RANO 2.0, assessed at Screening.\n* Adequate hematologic and organ functions\n\nKey Exclusion Criteria:\n\n* Any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including chemotherapy, investigational therapies, prior therapies targeting IDH1 or IDH2, anti-angiogenic therapies, tumor-treating fields, or radiotherapy.\n* High-risk features as assessed by the Investigator, including brainstem or spinal cord involvement either as primary location or by significant tumor extension, clinically relevant functional or neurocognitive deficits due to the tumor (deficits resulting from surgery are allowed), or uncontrolled seizures (defined as persistent seizures interfering with ability to comply with protocol requirements).\n* Evidence of leptomeningeal disease.\n* Use of therapeutic doses of steroids for signs\u002Fsymptoms of glioma. Participants taking physiologic doses (defined as equivalent of \\\u003C1.5 mg of dexamethasone equivalent) for medical conditions not related to glioma will be permitted.","ALL","18 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study comparing the efficacy and safety of safusidenib versus placebo in participants with residual or recurrent Grade 2 glioma (oligodendroglioma or astrocytoma) with an IDH1 mutation who have undergone surgery as their only treatment and are not in need of immediate chemotherapy or radiotherapy.",[26,27,28,29,30],"Grade 2 Glioma (Astrocytoma or Oligodendroglioma) With an IDH1 Mutation","Astrocytoma IDH Mutant Grade 2","Oligodendroglioma","Oligodendroglioma IDH-mutant and 1p\u002F19q-codeleted","IDH-mutant Gliomas",[32,33],"safusidenib","IDH1-mutant Glioma","NOT_YET_RECRUITING","2026-07-14",{"date":37,"type":38},"2026-07-17","ACTUAL",{"date":40,"type":20},"2027-03",{"date":42,"type":20},"2032-03",{"name":44,"class":45},"Nuvation Bio Inc.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":65,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100621751","observational-study-of-responses-to-treatments-in-advanced-central-nervous-system-cns-tumors-100621751","NCT07374692","Observational Study of Responses to Treatments in Advanced Central Nervous System (CNS) Tumors","* INCLUSION CRITERIA\n* Participants must have advanced CNS tumors confirmed by a documented pathology report, including:\n\n  * recurrent isocitrate dehydrogenase (IDH)-wild-type high-grade glioma\n  * recurrent IDH-mutant gliomas\n  * other recurrent CNS tumors\n* Participants must have been scheduled for a brain tumor biopsy or resection. Note: Scheduled brain tumor biopsy or resection must be at least 6 months after any previous radiation therapy, if applicable. All procedures are planned to take place at NIH.\n* Age \\>= 15 years.\n* Ability of participant, parent\u002Fguardian, or Legally Authorized Representative (LAR) to understand and sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\nNone.","15 Years","120 Years",{"count":55,"type":20},80,[57],"NA","Background:\n\nPrimary central nervous system (CNS) tumors grow in the brain and spinal cord. These tumors are rare, but they are difficult to treat and often fatal. SmartMatch is a new technology that tries to help find the best medicines for the particular tumor by testing how small pieces of surgically removed tumor tissue react to different drugs. The study team wants to see if SmartMatch can complete the analysis and generate a report within 21 days from the time of the surgery.\n\nObjective:\n\nTo better understand CNS tumors so doctors can find better ways to treat them in the future.\n\nEligibility:\n\nPeople aged 15 years and older with recurrent CNS tumors. Patient must already be scheduled for a surgery for the tumor at the NIH.\n\nDesign:\n\nThe study team will collect a small amount of tumor samples during the planned surgery. They may also use tumor samples from previous procedures. No new or additional procedures will be done for the purpose of this study.\n\nThe tumor samples will be sent to a lab for SmartMatch analysis. Once completed, the results will be shared with the patient and his\u002Fher local doctor. Together they can decide whether to incorporate the results into the treatment plan. It is important to know that the results may or may not be helpful.\n\nThere will only be one blood test for research. Blood and tissue samples collected may be used for additional analysis. Tumor tissue may be used to grow additional samples for further study. Participants will receive a pathology diagnosis and mutation profile generated by pathologists who specialize in CNS tumors.\n\nThe study team will seek updates on participant's health approximately every 6 months for 3 years. Tumor samples may also be collected from any additional surgery done at NIH during this time....",[60,61,62,63,30,64],"Recurrent CNS Tumors","Brain Cancer","Gliomas","IDH-wildtype Gliomas","Rare CNS Tumor",[66,67,68,69,62,70],"CNS Tumor","Brain Tumor","Rare Tumor","SmartMatch","Drug Screen","RECRUITING","2026-05-21",{"date":74,"type":38},"2026-05-22",{"date":76,"type":38},"2026-02-04",{"date":78,"type":20},"2030-12-30",{"name":80,"class":81},"National Cancer Institute (NCI)","NIH",1]