[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100456661":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":28,"locations":35,"responsibleParty":52,"collaborators":33,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":33,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":33,"enrollmentInfo":63,"targetDuration":33,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":38,"whyStopped":33,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"NanoPharmaceuticals LLC","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (fb-PMT)","EXPERIMENTAL","Daily subcutaneous injection of fb-PMT in four escalating cohorts to determine maximum tolerated dose, followed by treatment of up to 10 additional patients at maximum tolerated dose.",[13],"Drug: fb-PMT",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","fb-PMT","Daily dosing based on patient weight",[9],[21,22],"NP-100","NP751",[24],{"name":25,"affiliation":26,"role":27},"Nicholas Blondin, MD","Yale University","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Amy L Rodrigues, CCRC","CONTACT","(203) 260-9632",null,"amy.rodrigues@yale.edu",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Smilow Cancer Hospital","RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-72.92816,41.30815,{"lat":48,"lon":47},[51],{"name":25,"role":27,"phone":33,"phoneExt":33,"email":33},{"type":53,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR","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":64,"type":65},34,"ESTIMATED","INTERVENTIONAL",[68],"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.",[71],"Glioma, Malignant",[73,74],"Glioblastoma","Glioblastoma Multiforme","2025-05-29",{"date":77,"type":78},"2025-06-04","ACTUAL",{"date":80,"type":78},"2022-06-23",{"date":82,"type":65},"2027-10",{"name":5,"class":6},1]