[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100492928":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":57,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":38,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":38,"enrollmentInfo":72,"targetDuration":38,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":38,"overallStatus":43,"whyStopped":38,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"University of Nebraska","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single arm","EXPERIMENTAL","Participants will receive a combination of PCI-24781\u002FAbexinostat and temozolomide: loading dose of PCI-24781\u002FAbexinostat prior to the start of Cycle 1, PCI-24781\u002FAbexinostat by mouth twice a day starting 7 days prior to Cycle 1, Day 1 and ending 4 days prior to Cycle 1, Day 1.\n\nParticipants will continue taking PCI-24781\u002FAbexinostat on days 1 - 4, 8 - 11, and 15 - 18 of each 28 day cycle, starting with Cycle 1, Day 1. The initial dose level is 60 mg of PCI-2478\u002FAbexinostat by mouth twice daily. The dose level may be escalated based on results of interim data analysis.\n\nParticipants will additionally initiate metronomic temozolomide on Cycle 1, Day 1 at a dose of 50 mg\u002Fm2, taken by mouth twice daily and continue the PCI-24781\u002FAbexinostat and metronomic temozolomide regimen until disease progression or intolerance.",[13,14],"Drug: PCI 24781","Drug: Temozolomide",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","PCI 24781","Participants will take PCI-24781\u002FAbexinostat on days 1 - 4, 8 - 11, and 15 - 18 of each 28-day cycle.",[9],[22],"Abexinostat",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Temozolomide","Participants will receive temozolomide at a dose of 50 mg\u002Fmg2, taken by mouth once daily.",[9],[28],"Temodar",[30],{"name":31,"affiliation":5,"role":32},"Nicole A Shonka, MD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Michaela K Savine, RN","CONTACT","402-836-9488",null,"misavine@unmc.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"University of Nebraska Medical Center","RECRUITING","Omaha","Nebraska","68198","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-95.94043,41.25626,{"lat":53,"lon":52},[56],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},{"type":58,"investigatorFullName":38,"investigatorTitle":38,"investigatorAffiliation":38,"oldNameTitle":38,"oldOrganization":38},"SPONSOR",[60],{"name":61,"class":62},"Xynomic Pharmaceuticals, Inc.","INDUSTRY","100492928","phase-1-a-study-of-temodar-with-abexinostat-pci-24781-for-patients-with-recurrent-glioma-100492928",false,"NCT05698524","A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma","A Phase I Study of Metronomic Temozolomide With Abexinostat (PCI-24781) for Patients With Recurrent High Grade Glioma","Inclusion Criteria:\n\n* Pathologically proven diagnosis of high grade (aka grade III or IV) glioma (anaplastic astrocytoma, anaplastic oligodendroglioma, glioblastoma, gliosarcoma)\n* Prior radiation therapy and standard temozolomide; additional therapies for previous progressions are eligible (prior bevacizumab and Optune are allowed)\n* Three or more months from the end of chemoradiotherapy or have biopsy or imaging consistent with disease progression\n* 19 years of age or older (the age of consent in Nebraska)\n* Fully recovered from any toxicity of prior therapy that, in the opinion of the investigator, could impact tolerance to the study drug\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2\n* Adequate bone marrow reserve (ANC count ≥1,500\u002Fmm3, hemoglobin \\> 8 g\u002FdL, platelet count ≥100,000\u002Fmm3)\n* Adequate renal function (a serum creatinine that is at or below 2.0 mg\u002FdL)\n* Adequate hepatic function (serum AST and ALT less than 1.5 times the upper limits of normal, serum alkaline phosphatase less than 2.5 times the upper limits of normal)\n* Able to provide written, informed consent\n* Females of child-bearing potential must have a negative pregnancy test within 7 days of initiating study (non-child bearing potential is defined as age 55 years or older and no menses for two years or any age with surgical removal of the uterus and\u002For both ovaries)\n* Females of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and up to 6 months following treatment\n\nExclusion Criteria:\n\n* Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral PCI-24781\u002FAbexinostat, or put the study outcomes at undue risk\n* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmia, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification\n* Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction\n* Immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \\> 20 mg\u002Fday) or experimental therapy (other than PCI-24781\u002FAbexinostat PO) within 4 weeks before first dose of study drug\n* Concurrent use of enzyme-inducing antiepileptic drugs (phenytoin, phenobarbital, carbamazepine, felbamate, topiramate and oxcarbazepine)\n* Any other active malignancy other than nonmelanoma skin cancer or controlled prostate cancer\n* Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection (no testing is required for eligibility)\n* Creatinine \\> 1.5 x institutional upper limit of normal (ULN); total bilirubin \\> 1.5 x ULN (unless from Gilbert's disease), and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 2.5 x ULN\n* Pregnant or breast-feeding\n* Baseline ECG duration of the ventricular action potential corrected for heart rate (QTc interval) prolongation based on Fridericia's formula is \\> 450 ms in males and \\> 470 ms in females\n* Concomitant valproic acid use, or another histone deacetylases (HDAC) inhibitor\n* Receiving treatment with following medications and unable to discontinue treatment or switch medications prior to study enrollment:\n\n  * Amiodarone (Cordarone, Pacerone)\n  * Arsenic trioxide (Trisenox)\n  * Chlorpromazine (Aralen)\n  * Cisapride (Propulsid)\n  * Clarithromycin (Biaxin)\n  * Disopyramide (Norpace)\n  * Dofetilide (Tikosyn)\n  * Doperidol (Inapsine)\n  * Erythromycin (EryTab, Erythrocin)\n  * Flecanide (Tambocor)\n  * Haloperidol (Haldol)\n  * Ibutilide (Corvert)\n  * Methadone (Methadose, Dolophine)\n  * Moxifloxacin (Avelox)\n  * Pentamidine (Pentam, Nebupent)\n  * Pimozide (Orap)\n  * Procainamide (Procan, Pronestyl)\n  * Quinidine (Cardioquin, Quinaglute)\n  * Sotalol (Betapace)\n  * Thioridazine (Mellaril)\n  * Vandetanib (Zactima)","ALL","19 Years",{"count":73,"type":74},24,"ESTIMATED","INTERVENTIONAL",[77],"PHASE1","Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781\u002FAbexinostat with metronomic temozolomide.",[80,81,82,83,84],"Recurrent High Grade Glioma","Anaplastic Astrocytoma","Anaplastic Oligodendroglioma","Glioblastoma","Gliosarcoma","2026-04-13",{"date":87,"type":88},"2026-04-17","ACTUAL",{"date":90,"type":88},"2023-06-26",{"date":92,"type":74},"2029-07",{"name":5,"class":6},1]