[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"NanoPharmaceuticals LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100456661","phase-1-safety-and-tolerability-of-fb-pmt-in-recurrent-glioblastoma-100456661",false,"NCT05226494","Safety and Tolerability of Fb-PMT in Recurrent Glioblastoma","A Phase 1 Trial to Evaluate the Safety and Tolerability of Fb-PMT in Patients With Recurrent Glioblastoma","Inclusion Criteria:\n\n* Histologically proven intracranial glioblastoma, with first or second recurrence\n* On stable or decreasing dose of steroids, if taken prior to screening\n* Baseline MRI (with and without contrast) completed with 5 days of starting fb-PMT\n* Prior completion of and recovery from the effects of standard of care for glioblastoma management with surgery\u002Fbiopsy and radiotherapy\n* Confirmation of true progressive disease for patients previously treated with interstitial brachytherapy or stereotactic radio surgery\n* Life expectancy of more than three months\n* Karnofsky Performance Status of ≥ 70\n* Hypertension must be well controlled (≤ 95th percentile) on stable doses of medication\n* Adequate bone marrow and organ function, confirmed by laboratory testing at screening\n* Patient or caregiver must be able to store drug under refrigerated conditions, prepare and administer daily subcutaneous injections on a set schedule, and record information in a daily treatment diary\n* Women of childbearing potential must agree to ongoing pregnancy testing and to use medically acceptable contraception for the duration of the study and for 2 months after their last dose of study drug\n* Males must agree to use medically acceptable contraception and refrain from donating sperm for the duration of the study and for 2 months after their last dose of study drug\n\nExclusion Criteria:\n\n* Significant medical illness that is uncontrolled, may obscure toxicity, may dangerously alter drug metabolism, or may compromise ability for study participation\n* History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission and off all therapy for that disease for at least 3 months prior to first dose of study drug\n* Use of bevacizumab or any other experimental drug or therapy within 28 days of study treatment\n* Prior therapy with fb-PMT or related drugs\n* Currently pregnant or breastfeeding\n* Active infection or serious intercurrent medical illness\n* Surgery of any type within the preceding 28 days that has not fully healed\n* A serious or non-healing wound, ulcer, or bone fracture\n* A known bleeding diathesis or coagulopathy, or a history of bleeding diathesis within 28 days of study treatment\n* A known thrombophilic condition (i.e., protein S, protein C, or antithrombin III deficiency, Factor V Leiden, Factor II G20210A mutation, homocysteinemia or antiphospholipid antibody syndrome). Testing is not required in patients without thrombophilic history.\n* Evidence of new central nervous system hemorrhage on baseline MRI obtained within 14 days prior to study enrollment\n* Clinically significant cardiovascular event such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening.\n* New York Heart Association classification of heart disease greater than Class 2\n* QTc interval \\> 450 msec in males or \\> 470 msec in females at screening\n* Use of concomitant medications that prolong the QT\u002FQTc interval or risk inducing Torsades de Pointes\n* Use of any concomitant OATP1B1, OATP1B3, or BSEP inhibitors within 14 days or five half-lives (whichever is longer) before starting study drug treatment\n* Abdominal fistula, gastrointestinal perforation, or intraabdominal abscess within 6 months prior to study enrollment\n* A significant vascular disease (e.g., aortic aneurysm requiring surgical repair, deep venous or arterial thrombosis) within the last 6 months prior to study enrollment\n* History of stroke, myocardial infarction, transient ischemic attack (TIA), severe or unstable angina, peripheral vascular disease, or grade II or greater congestive heart failure within the past 6 months\n* History of Torsades de Pointes or risk factors for Torsades de Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)","ALL","18 Years",{"count":19,"type":20},34,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Glioblastoma is a highly aggressive and fatal form of primary malignant brain tumor with limited treatment options. fb-PMT affects a large group of cancer cell signaling pathways and thus may be effective in heterogeneous, treatment-resistant tumors such as Glioblastoma. fb-PMT also is actively transported across the blood-brain barrier into the brain. This study is being conducted to determine the dose level for further clinical development of fb-PMT to treat recurrent Glioblastoma.",[26],"Glioma, Malignant",[28,29],"Glioblastoma","Glioblastoma Multiforme","RECRUITING","2025-05-29",{"date":33,"type":34},"2025-06-04","ACTUAL",{"date":36,"type":34},"2022-06-23",{"date":38,"type":20},"2027-10",{"name":40,"class":41},"NanoPharmaceuticals LLC","INDUSTRY",""]