[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Imaging Biometrics, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":36},{"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":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":24,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":32,"locationsCount":35},"100547135","expanded-access-to-gallium-maltolate-gam-100547135",false,"NCT06404034","Expanded Access to Gallium Maltolate (GaM)","Expanded Access to Gallium Maltolate (GaM) for Adult Patients With Relapsed\u002FRefractory Histologic or Molecular Glioblastoma","Inclusion Criteria:\n\n1. Patient has relapsed\u002Frefractory histologic or molecular glioblastoma who, in the opinion of the treating physician, may benefit from treatment from GaM.\n2. Male or female patient aged ≥ 18 years.\n3. In the opinion of the treating physician, the patient has adequate organ function to tolerate GaM.\n4. Patient must be able to swallow and retain orally administered medication.\n5. For females of childbearing potential, negative urinary or serum pregnancy test.\n6. Patients must be willing to highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration.\n7. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant.\n8. Ability to understand a written informed consent document, and the willingness to sign it by the patient or legally authorized patient representative (LAR) or guardian.\n9. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088)\n\nExclusion Criteria:\n\n1. Patient is already participating in or is able to enroll in a clinical trial of GaM.\n2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting GaM treatment, whichever is shorter.\n3. Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.\n4. Patient is taking oral iron supplements or iron chelators.\n5. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with GaM due to safety concerns.\n6. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with GaM.\n7. Known hypersensitivity to GaM or any component in its formulation.\n8. Patients taking prohibited medications as described in the current Investigator's Brochure.\n9. Patient is pregnant or actively breastfeeding","ALL","18 Years","EXPANDED_ACCESS","The objective of this program is to provide GaM for compassionate use in patients with relapsed\u002Frefractory histologic or molecular glioblastoma who have exhausted available treatments.\n\nThe population of this program is adult patients aged greater than or equal to 18 years with a diagnosis of relapsed\u002Frefractory histologic or molecular glioblastoma, according to the WHO 2021 diagnostic criteria.\n\nMolecular glioblastoma is characterized as an IDH-wildtype diffuse and astrocytic glioma in adults if there is microvascular proliferation or necrosis or TERT promoter mutation or EGFR gene amplification or +7\u002F-10 chromosome copy number changes",[21,22,23],"Glioblastoma","Refractory Glioblastoma","Glioblastoma Multiforme",[25,26],"glioblastoma","refractory glioblastoma","AVAILABLE","2026-06-04",{"date":30,"type":31},"2026-06-08","ACTUAL",{"name":33,"class":34},"Imaging Biometrics, LLC","INDUSTRY",3,""]