[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurological-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurological-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,69],{"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":27,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"100356557","phase-1-astx727-in-recurrentprogressive-non-enhancing-idh-mutant-gliomas-100356557",false,"NCT03922555","ASTX727 in Recurrent\u002FProgressive Non-enhancing IDH Mutant Gliomas","Phase I Trial of ASTX727 in Recurrent\u002FProgressive Non-enhancing IDH Mutant Gliomas","Inclusion Criteria:\n\n* Participants must be ≥18 years of age.\n* Participants must have histologically or cytologically confirmed glioma, with documented IDH1 and\u002For IDH2 gene-mutation.\n* Participants must have radiographic evidence of non-enhancing disease progression\u002Frecurrence per RANO criteria for low grade gliomas (LGG).\n* Patients who have received prior treatment with chemotherapy, radiation, or a combination of both are eligible. Also, patients who have not received any prior treatment for their glioma are also eligible.\n* Participants must be ≥12 weeks from completion of radiation.\n* Participants must have a baseline brain MRI scan within 28 days prior to Day 1 of treatment.\n* Participants must be on a stable or decreasing dose of glucocorticoids for 7 days prior to registration.\n* Participants must have archived primary tumor biopsies or surgical specimens for additional exploratory translational studies. At least 100-micron length of FFPE tissue or a tissue block should be available for enrollment and for shipment to the Sponsor, or a laboratory designated by the Principal Investigator. If less material is available, participants could still be eligible after discussion with the Principal Investigator who will assess and confirm that there is sufficient material for key evaluations.\n* Participants must be able to understand and willing to sign an informed consent. A legally authorized representative may consent on behalf of a participant who is otherwise unable to provide informed consent, if acceptable to and approved by the site and\u002For site's Institutional Review Board (IRB)\u002FIndependent Ethics Committee (IEC).\n* Participants must have KPS ≥ to 70\n* Participants must have expected survival of ≥ 6 months.\n* Participants must have adequate bone marrow function as evidenced by:\n\n  * Leukocytes ≥ 3,000\u002FmcL\n  * Absolute neutrophil count ≥1500\u002FmcL;\n  * Hemoglobin ≥10 g\u002FdL\n  * Platelets ≥100,000\u002FmcL\n* Participants must have adequate hepatic function as evidenced by:\n\n  * Serum total bilirubin ≤1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease\n  * Aspartate aminotransferase (AST), Alanine Aminotransferase (ALT), and alkaline phosphatase (ALP) ≤3.0 x ULN.\n* Participants must have adequate renal function as evidenced by:\n\n  * Serum creatinine ≤2.0 x ULN\n  * OR Creatinine clearance \\>40 mL\u002Fmin based on the Cockroft-Gault glomerular filtration rate (GFR) estimation: (140 - Age) × (weight in kg) × (0.85 if female)\u002F72 × serum creatinine\n* Participants must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer. (Participants with residual Grade 1 toxicity due to prior chemotherapy are allowed).\n* Female participants with reproductive potential must have a negative serum pregnancy test within 14 days prior to the first study drug administration. Participants with reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy or tubal occlusion or who have not been naturally postmenopausal (i.e., who have not menstruated at all) for at least 24 consecutive months (i.e., have had menses at any time in the preceding 24 consecutive months). Women with reproductive potential as well as fertile men and their partners who are female with reproductive potential must agree to abstain from sexual intercourse or to use 2 effective forms of contraception from the time of giving informed consent, during the study, and for 90 days (females and males) following the last dose of ASTX727.\n* Participants enrolling in the expansion cohort (Arm B) must meet all of the above criteria and must have surgically accessible tumors and be surgical candidates.\n\nExclusion Criteria:\n\n* Participants with enhancing disease on brain MRI.\n* Participants who received systemic anticancer therapy \\\u003C28 days prior to registration. One exception: participants on lomustine\u002FCCNU must wait at least 42 days from last date of drug administration to registration.\n* Participants who received an investigational agent \\\u003C14 days prior to registration. In addition, the first dose of ASTX727 should not occur before a period ≥5 half-lives of the investigational agent has elapsed.\n* Participants with prior treatment with bevacizumab (Avastin) are excluded.\n* Participants who are pregnant or breast-feeding.\n* Participants with an active severe infection that requires anti-infective therapy or with an unexplained fever \\>38.5°C during screening visits or on their first day of study drug administration.\n* Participants with known additional malignancy that is progressing or requires active treatment within 2 years of start of study drug. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer that has undergone potentially curative therapy, or surgically treated prostate cancer.\n* Participants with known hypersensitivity to any of the components of ASTX727.\n* Participants with a history of myocardial infarction within the 6 months prior to screening.\n* Participants with a known history of severe and\u002For uncontrolled ventricular arrhythmias.\n* Participants with QTc interval ≥450 msec or with other factors that significantly increase the risk of QT prolongation or arrhythmic events (e.g., family history of long QT interval syndrome).\n* Participants with known infection with human immunodeficiency virus (HIV) or active hepatitis B or C.\n* Participants with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a participant's ability to sign informed consent, cooperate, or participate in the study.\n* Participants with known dysphagia, short-gut syndrome, gastroparesis, or other conditions that limit the ingestion or gastrointestinal absorption of drugs administered orally.\n* Participants with evidence of intracranial or intratumoral hemorrhage either by MRI or CT scan. Participants with resolving post-surgical changes, punctate\u002Fmicro-hemorrhage, or hemosiderin are eligible.\n* Participants enrolling in the expansion cohort will be excluded is they are deemed by the treating physician or surgeon not to be suitable for surgery","ALL","18 Years",{"count":19,"type":20},18,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","this research study is evaluating the highest dose of ASTX727 that can be administered safely to recurrent\u002Fprogressive non-enhancing IDH mutant gliomas patients.",[26],"Neurological Cancer",[26],"RECRUITING","2026-04-13",{"date":31,"type":32},"2026-04-16","ACTUAL",{"date":34,"type":32},"2019-07-12",{"date":36,"type":20},"2028-08-01",{"name":38,"class":39},"Massachusetts General Hospital","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":68},"100447460","wearable-devices-and-biomarkers-project-healthiomics-100447460","NCT05106725","Wearable Devices and Biomarkers Project (Healthiomics)","Study of Clinical Biomarkers in Human Health and Disease (Healthiomics)","Inclusion Criteria:\n\n* Participant or participant's legally authorized representative has the ability to understand and the willingness to provide a signed and dated informed consent form.\n* Participant is ≥ 18 years of age.\n* Participant had\u002Fhas a scheduled appointment with oncology or neurosciences services at the participating medical and surgical facility.\n* Participant is characterized by at least one of the following criteria:\n\n  1. Has a neurological complication from any type of cancer, or is under evaluation for a possible cancer diagnosis or neurologic complication. Participant may be newly diagnosed, in relapse, or be free of disease at the time of recruitment. Participant without a confirmed cancer diagnosis is eligible.; OR\n  2. Has a neurological disorder, or is under evaluation for a possible diagnosis of a neurological disorder; OR\n  3. Does not meet the characteristic of either a. or b. above. This participant would be considered a \"healthy control\" for cancer and neurological disorders.\n\nExclusion Criteria:\n\n* Participant or participant's legally authorized representative is unable to provide informed consent.",true,{"count":49,"type":20},3500,"OBSERVATIONAL","The purpose of this study is to collect clinical data, biological specimens (e.g., blood, tumor, cerebrospinal fluid, urine sample, etc.), and digital health data from patients with tumors, cancer and\u002For neurological disorders in order to perform research studies that could advance patient care. By collecting these specimens, the investigators plan to create and maintain a biorepository to make data and specimens available to collaborating investigators performing research to discover predictive biomarkers, patterns of care, and personalized treatments that could directly improve the care of our patients through focused proof-of-concept clinical trials.",[53,54,26],"Brain Cancer","Neurological Disorder",[56,57,58],"wearables","digital health","biospecimens","2024-08-19",{"date":61,"type":32},"2024-08-21",{"date":63,"type":32},"2021-10-11",{"date":65,"type":20},"2025-12-31",{"name":67,"class":39},"CureScience",1,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":50,"phases":4,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":68},"100556730","standard-follow-up-program-neuro-oncology-patients-sfp-neuro-oncology-100556730","NCT06528912","Standard Follow-up Program Neuro-oncology Patients (SFP Neuro-Oncology)","Standard Follow-up Program (SFP) for Neuro-oncology Cancer Patients Treated With Radiotherapy","Inclusion Criteria:\n\n* Patient with neuro-oncological cancer\n* Patient receiving a radiotherapy dose XXX Gy\n\nExclusion Criteria:\n\n* Failure to comply with any of the inclusion criteria",{"count":77,"type":20},10000,"Standardised evaluation of baseline data regarding tumor-, patient- and treatment-characteristics as well as follow-up data regarding tumor- and clinical-outcome of neuro-oncology patients treated with radical\u002Fcurative radiotherapy.\n\nMotive:\n\nCurrently there is limited data on dose-effect relationships of tissues and structures in and around the brain. This lack of knowledge hampers patient selection for proton therapy, technique innovations, and accurate prediction of treatment outcome.\n\nGoal:\n\nTo evaluate the selection for radiation treatment, obtain more knowledge on dose-effect relationships and enable insight in necessary treatment technique innovations that would improve treatment outcome.",[26],[81,82,83],"Acute toxicity","Late toxicity","Prediction models","2024-07-29",{"date":86,"type":32},"2024-07-30",{"date":88,"type":32},"2017-12-01",{"date":90,"type":20},"2040-01",{"name":92,"class":39},"University Medical Center Groningen"]