The objective of this program is to provide GaM for compassionate use in patients with relapsed/refractory histologic or molecular glioblastoma who have exhausted available treatments.
The population of this program is adult patients aged greater than or equal to 18 years with a diagnosis of relapsed/refractory histologic or molecular glioblastoma, according to the WHO 2021 diagnostic criteria.
Molecular 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/-10 chromosome copy number changes
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patient has relapsed/refractory histologic or molecular glioblastoma who, in the opinion of the treating physician, may benefit from treatment from GaM.
. Male or female patient aged ≥ 18 years.
. In the opinion of the treating physician, the patient has adequate organ function to tolerate GaM.
. Patient must be able to swallow and retain orally administered medication.
. For females of childbearing potential, negative urinary or serum pregnancy test.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an expanded access program rather than a standard clinical trial, what does that mean for how gallium maltolate's safety and effectiveness are known so far, and how does that affect what we could expect for my situation?
2Expanded access is typically offered when other treatments haven't worked — given that this is specifically for refractory glioblastoma, does my treatment history make me a reasonable candidate to discuss this option with you?
3Gallium is a metal-based compound, which is different from typical chemotherapy — can you explain how gallium maltolate is thought to work against glioblastoma cells, and what side effects have been reported so far?
4Because this is expanded access rather than a Phase 1, 2, or 3 trial, will I still be closely monitored for safety and response, and how would my care be managed if the treatment isn't working or causes problems?
5Before considering this expanded access program, are there any standard treatments or active clinical trials for refractory glioblastoma that we should weigh against it first?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.
Exclusion criteria
. Patient is already participating in or is able to enroll in a clinical trial of GaM.
. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting GaM treatment, whichever is shorter.
. Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation.
. Patient is taking oral iron supplements or iron chelators.
. 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.
. 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.
. Known hypersensitivity to GaM or any component in its formulation.
. Patients taking prohibited medications as described in the current Investigator's Brochure.