[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"astrocytoma-idh-mutant-grade-4\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:astrocytoma-idh-mutant-grade-4":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,80],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":35,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100462580","phase-3-sigma-safusidenib-in-idh1-mutant-glioma-maintenance-100462580",false,"NCT05303519","SIGMA (Safusidenib in IDH1 Mutant Glioma Maintenance)","A Phase 3, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of Safusidenib Erbumine in Participants With Isocitrate Dehydrogenase 1 (IDH1)-Mutant Glioma","SIGMA","Key Inclusion Criteria for Part 1:\n\n1. Patient must be ≥ 18 years of age at the time of signing the informed consent form (ICF).\n2. Patient must have histologically confirmed recurrent or progressive WHO Grade 2 glioma or Grade 3 glioma with IDH1 R132H or R132C mutation confirmed by immunohistochemistry or molecular genetic testing.\n3. The IDH mutation, and other applicable gene\u002Fmolecular alterations (see Table 10-2) are determined by a validated assay as performed in Clinical Laboratory Improvement Amendments (CLIA)-certified\u002FCollege of American Pathologists (CAP)-accredited or locally equivalent clinical laboratories. Prior clinical pathology report fulfilling the diagnosis criteria prior to screening with tumor samples collected is acceptable for patient enrollment in both Part 1 and Part 2.\n4. Patient has received no more than 2 prior therapies for disease recurrence\u002Fprogression.\n5. Patient has disease recurrence or progression or cannot tolerate the most recent therapy.\n6. Patient must have a measurable lesion(s) as per the RANO-HGG criteria for primarily enhancing lesions or RANO-LGG criteria for primarily non-enhancing lesions. The lesion (s) must be visible on 2 or more axial slices and have perpendicular diameters of at least 10 × 10 mm. The definition of primarily enhancing lesions or primarily non-enhancing lesions is referred to Section 8.3.1.\n\nKey Inclusion Criteria for Part 2 and 3:\n\n1. Must be ≥18 years old at the time of signing the ICF.\n2. Must agree to submit sufficient tumor tissue for retrospective biomarker and histological analyses. This requirement may be waived in rare circumstances with approval by the Sponsor.\n3. Has adequate hematologic and organ function\n\nKey Inclusion Criteria for Part 2:\n\n1. Diagnosis of histologically confirmed IDH1-mutant Grade 2, Grade 3 with high risk features or Grade 4 astrocytoma, per WHO 2021 classification and Investigator Assessment.\n2. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL) based on IHC (R132H only), polymerase chain reaction (PCR), or next-generation sequencing (NGS). CDKN2A\u002FB status and at least 1 of the following must be confirmed: absence of 1p19q co-deletion by fluorescence in situ hybridization, array comparative genomic hybridization, or NGS; presence of an ATRX loss of function mutation by NGS; or loss of normal ATRX expression by IHC. A validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory must be used for all of the aforementioned results. Documentation of biomarker status, including redacted molecular pathology and NGS reports, must be provided during Screening.\n3. Must not have experienced tumor recurrence or progression between first day of radiotherapy and randomization by local assessment per RANO 2.0.\n4. Participants must have completed radiation therapy with a minimum of 80% of planned treatment completed (with or without concurrent temozolomide) and between 6 and 12 cycles of adjuvant . Randomization must occur at least 28 days and not more than 75 days after the final dose of temozolomide.\n\nKey Inclusion Criteria for Part 3:\n\n1. Have had 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 and no longer than 5 years before the date of enrollment, 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.\n2. Have histologically confirmed Grade 3 IDH-mutant oligodendroglioma according to WHO 2021 criteria per local assessment.\n3. Have residual or recurrent measurable disease per RANO 2.0 and confirmed by BICR, at the time of enrollment.\n4. Have an IDH1 mutation (R132H\u002FC\u002FG\u002FS\u002FL). The presence of 1p19q co-deletion must also be confirmed. All results must be generated using a validated assay performed in a CLIA-certified\u002FCAP-accredited (or local equivalent) clinical laboratory.\n\nKey Exclusion Criteria for Part 1:\n\n1. Prior anti-cancer therapy, within the applicable periods shown below, before the start of the protocol treatment:\n2. Systemic drug therapies: within 3 weeks (lomustine within 6 weeks)\n3. Surgery: within 3 weeks\n4. Radiation therapy: within 12 weeks\n5. Investigational agents: within 5 half-lives for other investigational agents\n6. Patient did receive the prior therapy targeted to IDH1 mutation..\n7. Known hypersensitivity to safusidenib or to any drug with similar chemical structure or to any other excipient present in the pharmaceutical form of safusidenib.\n\nKey Exclusion Criteria for Part 2 and 3:\n\n1. Participants with prior or anticipated treatment with anti-angiogenic agents such as Avastin (bevacizumab), agents known to target IDH1 or IDH2, or investigational agents for glioma are excluded.\n2. Have brainstem or spinal cord involvement either as primary location, site of multifocal involvement, or by significant tumor extension.\n3. Significant functional or neurocognitive deficits, including uncontrolled seizures, that would preclude participation in protocol-defined study activities, as assessed by Investigator.\n4. Evidence of diffuse leptomeningeal disease.\n5. History of significant cardiac disease within 12 months prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n6. If taking corticosteroids, must be on a stable or decreasing dose for the 14 days prior to randomization (if applicable) or first dose of study drug (if randomization does not apply).\n7. Participants with other malignancies must have received curative treatment and been disease-free for at least 3 years. Curatively resected skin cancer or curatively treated carcinoma in situ is allowed.\n8. Have a condition that would interfere with, or increase the risk of, study participation.\n\nKey Exclusion Criteria for Part 2 1. Participants may not have received any anticancer treatments other than surgery, radiation, concurrent\u002Fadjuvant temozolomide, and tumor-treating fields. Tumor-treating fields must be discontinued prior to randomization.\n\nKey Exclusion Criteria for Part 3:\n\n1\\. Participants may not have received any prior anticancer therapy other than surgery (biopsy, sub-total, or gross total resection) for treatment of glioma, including radiotherapy.","ALL","18 Years",{"count":20,"type":21},365,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a 3-part study. The purpose of Part 1 of the study is to evaluate the efficacy, safety, and pharmacokinetic (PK) characteristics of safusidenib in participants with recurrent\u002Fprogressive IDH1-mutant World Health Organization (WHO) Grade 2 or Grade 3 glioma.\n\nThe purpose of Part 2 will be to evaluate the efficacy of maintenance safusidenib treatment versus placebo in IDH1-mutant Grade 2 or Grade 3 astrocytoma with high-risk features or IDH1-mutant Grade 4 astrocytoma, following standard-of-care radiation or chemoradiation and adjuvant temozolomide. Part 2 will be randomized, double-blind, and placebo-controlled.\n\nThe purpose of Part 3 will be to evaluate the efficacy of safusidenib in participants with residual or recurrent IDH1-mutant Grade 3 oligodendroglioma who have received surgery as their only treatment. Part 3 will be an open-label single-arm cohort and will enroll participants concurrently with Part 2.",[27,28,29,30,31,32,33,34],"Glioma","Astrocytoma, Grade IV","IDH1-mutant Glioma","Astrocytoma, IDH-Mutant, Grade 3","Astrocytoma, IDH-Mutant, Grade 4","Astrocytoma, IDH-Mutant, Grade 2","Oligodendroglioma","Oligodendroglioma, IDH-Mutant and 1p\u002F19q-Codeleted",[36,37,38],"safusidenib","IDH1-mutant glioma","astrocytoma","RECRUITING","2026-06-29",{"date":42,"type":43},"2026-07-01","ACTUAL",{"date":45,"type":43},"2023-06-05",{"date":47,"type":21},"2030-12-01",{"name":49,"class":50},"Nuvation Bio Inc.","INDUSTRY",57,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100628937","phase-1-retifanlimab-with-or-without-difluoromethylornithine-for-the-treatment-of-progressive-high-grade-gliomas-100628937","NCT07468136","Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade Gliomas","Phase I\u002FIIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of high-grade glioma, including any of the following:\n\n  * Glioblastoma, IDH-wild type (WT)\n  * Grade 3 or 4 IDH1\u002F2 mutant astrocytoma or\n  * Grade 3 oligodendroglioma\n  * Any prior grade 2 astrocytoma or oligodendroglioma that is suspected to have recurred at a higher grade\n  * Other high-grade glioma\n* Plan for surgical resection as part of routine clinical care\n* Radiographic disease progression, with or without tissue confirmation\n* Measurable disease\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1 or 2 and Karnofsky Performance Status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 15 days prior to registration)\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 15 days prior to registration)\n* Calculated creatinine clearance ≥ 45 ml\u002Fmin using the Cockcroft-Gault formula (obtained ≤ 15 days prior to registration)\n* Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only\n* Provide written informed consent for the current study\n* Willing to provide consent for the Neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples\n* Ability to complete forms by themselves or with assistance\n* Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Uncontrolled intercurrent illness that by the judgement of the investigator would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the regimens including, but not limited to:\n\n  * ongoing or active infection (e.g., pneumonia, sepsis, etc.) requiring systemic therapy\n  * current diagnosis or previous history of immune-related (non-infectious) pneumonitis or interstitial lung disease that requires or required steroids\n  * active autoimmune disease that required systemic treatment other than replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids) ≤ 2 years prior to registration\n  * symptomatic congestive heart failure\n  * unstable angina pectoris\n  * psychiatric illness\u002Fsocial situations that would limit compliance with study requirements (e.g., drug addiction)\n  * concurrent active Hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] positive and\u002For detectable hepatitis B virus \\[HBV\\] deoxyribonucleic acid \\[DNA\\]) and Hepatitis C virus (defined as anti-hepatitis C virus \\[HCV\\] antibody \\[Ab\\] positive and detectable HCV ribonucleic acid \\[RNA\\]) infection\n\nEXCEPTIONS:\n\n* Patients with evidence of hepatitis B virus (HBV) infection (HBsAg positive) must have completed at least 4 weeks of HBV antiviral therapy, and the HBV viral load must be undetectable at the time of registration\n* Patients with a history of hepatitis C virus (HCV) are eligible if they have an undetectable HCV viral load. Patients must have completed curative anti-viral treatment ≥ 4 weeks prior to registration.\n\n  * NOTE: Patients without symptoms or prior history do not require testing prior to registration\n\n    * Co-morbid systemic illnesses or other severe concurrent disease that would make the patient inappropriate for entry into the study or interfere with proper assessment of safety and toxicity\n    * History of myocardial infarction ≤ 6 months prior to registration or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n    * Active autoimmune disease that has required systemic treatment (other than replacement therapy) ≤ 1 year prior to registration\n    * History of allogeneic stem cell transplant\n    * Receiving any other investigational agent with therapeutic intent\n    * Participants who are unable to swallow the DFMO solution or who are at risk for impaired absorption of oral medication.\n* NOTE: This restriction includes, but is not limited to, refractory vomiting, gastric resection\u002Fbypass, and duodenal\u002Fjejunal resection\n\n  * Patients with known hypersensitivity or allergy to DFMO or retifanlimab\n  * Contraindication to MRI or administration of gadolinium",{"count":60,"type":21},33,[62,63],"PHASE1","PHASE2","This phase I\u002FII trial tests the safety, side effects best dose and effect of retifanlimab with or without difluoromethylornithine (DFMO) for the treatment of high grade gliomas that are growing, spreading, or getting worse (progressive). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. DFMO is in a class of medications called ornithine decarboxylase (ODC) inhibitors. It works by blocking the action of a substance that signals tumor cells to multiply. This helps stop or slow the spread of tumor cells. Giving retifanlimab with or without DFMO mat be safe, tolerable and\u002For effective in treating patients with progressive high grade glioma.",[66,30,31,67,68,69],"Anaplastic Oligodendroglioma","Diffuse Astrocytoma","Glioblastoma, IDH-Wildtype","Malignant Glioma","2026-06-23",{"date":72,"type":43},"2026-06-24",{"date":70,"type":43},{"date":75,"type":21},"2030-10-25",{"name":77,"class":78},"Mayo Clinic","OTHER",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":79},"100564007","extensive-resection-of-malignant-brain-tumors-using-advanced-imaging-techniques-100564007","NCT06623565","Extensive Resection of Malignant Brain Tumors Using Advanced Imaging Techniques","Multimodal Image-guided Resection of IDH Wildtype Glioblastoma and Grade IV IDH-mutant Astrocytoma","NEXTFRONTIER","Inclusion Criteria:\n\n* Age ≥ 18 years\n* New clinical and radiological suspected diagnosis of IDH-wildtype glioblastoma or grade IV IDH-mutant astrocytoma\n* Visible FET PET uptake in the tumor as assessed by the nuclear physician\n* Indication for a surgical resection and adjuvant treatment according to the neuro oncology multidisciplinary meeting\n* Eligible for a supramarginal resection according to two neurosurgeons in consensus\n* Karnofsky Performance Score (KPS) ≥ 70.\n\nExclusion Criteria:\n\n* Previous brain surgery or cranial radiotherapy\n* No significant other brain pathology, in the opinion of the PI or designee, such as multiple sclerosis, neurodegenerative disease, stroke\n* Tumor located infratentorially or in the spinal cord\n* Lack of adequate social or family support needed for adherence to the further postoperative therapeutic regimen\n* Pregnancy",{"count":89,"type":21},30,[91],"NA","Rationale: Patients with IDH-wildtype glioblastoma or grade IV IDH-mutant astrocytoma have a very poor prognosis despite standard treatment consisting of surgery, radiotherapy, and chemotherapy. Diffuse infiltration of the brain by the tumor is thought to be one of the main causes of this therapy-resistance. In order to improve the surgical treatment, tumor regions with lower infiltration percentages need to be identified and resected during surgery, a so-called supramarginal resection. Currently, pre-operative T1 contrast enhanced weighted (T1c) MRI is used to identify the tumor for resection. We recently found the combination of apparent diffusion coefficient MRI and O-(2-\\[ 18F\\]fluoroethyl-)-L-tyrosine positron emission tomography (ADC\u002FFET) to be significantly more accurate than T1c MRI alone in the detection of tumor infiltration. This makes ADC\u002FFET a suitable candidate to guide supramarginal resection. Since FET PET is not as accessible and widely available as MRI, identification of an MRI based alternative could result in a more widespread implementation. Amide proton transfer chemical exchange saturation transfer (APT-CEST) MRI is a novel potential alternative for FET PET, since both measures are related to protein content.\n\nObjective: In this project we aim to develop a safe and effective technique for ADC\u002FFET guided resection of IDH-wildtype glioblastoma and grade IV IDH-mutant astrocytoma. The safety concerns neurological deficits and time to start of adjuvant therapy, while the effectiveness is aimed at the extent of resection. Our secondary aim is to evaluate the diagnostic accuracy of APT-CEST MRI and to assess whether APT-CEST MRI can serve as an alternative for FET PET for the detection of tumor infiltration.\n\nStudy design: prospective observational intervention study\n\nStudy population: 30 patients with clinical and radiological diagnosis of an untreated high grade glioma (suspected for glioblastoma (IDH wildtype) or grade IV astrocytoma (IDH mutant)), who are eligible for a supramarginal surgical resection and adjuvant treatment according two neurosurgeons in consensus and who are in relatively good condition (Karnofsky Performance Score (KPS) ≥70).\n\nIntervention (if applicable): supramarginal ADC\u002FFET-guided resection. To make sure that the standard treatment is always guaranteed, T1c MRI abnormalities will be included in the surgical target.\n\nMain study parameters\u002Fendpoints: the main study endpoint is the optimization of ADC\u002FFET-guided resection. Volumetric and percentual extent of resection, as measured with MRI and PET imaging, combined with surgery-induced morbidity will be used as outcome parameters. The secondary study parameters will be the histopathology-based diagnostic accuracy of APT-CEST MRI in comparison with FET PET, cognitive performance over time and progression free survival.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: participants will undergo pre- and postoperative MRI scanning. This is also part of regular clinical care, except there are additional MRI sequences including APT CEST in the pre-operative and pre-radiotherapy MRI. There are no risks associated with MRI acquisition after MRI safety screening. Participants will furthermore undergo a pre- and postoperative FET PET. The risks associated with PET scanning are limited, and the radiation burden will remain below 10 mSv (ICRP62 category intermediate risk (level IIb)). During surgery, biopsies are performed from areas that will be resected, so these biopsies will not introduce any extra risk. A potential benefit is the possibility of the removal of more tumor tissue. A potential risk is the additional removal of healthy brain tissue with the risk of neurological damage, which is controlled by pre- and intraoperative techniques such as visualization of white matter tracts and mapping (both asleep and awake) of critical functions such as language and control of strength.",[94,31],"Glioblastoma",[96,97,98,99,100,101],"multimodal imaging","high grade glioma","glioblastoma","supramarginal","resection","surgery","2024-09-30",{"date":104,"type":43},"2024-10-02",{"date":106,"type":43},"2024-04-01",{"date":108,"type":21},"2027-04",{"name":110,"class":78},"Amsterdam UMC, location VUmc"]