Last-resort drug offered to brain cancer patients
NCT ID NCT06404034
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This program provides gallium maltolate (GaM) to adults aged 18 and older with glioblastoma that has returned or is not responding to standard treatments. The goal is to offer a possible treatment option when no others are available. Patients must be able to swallow capsules and have adequate organ function to participate.
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Study facts
What this study's own registry entry says, in plain language.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patient has relapsed/refractory histologic or molecular glioblastoma who, in the opinion of the treating physician, may benefit from treatment from GaM. 2. Male or female patient aged ≥ 18 years. 3. In the opinion of the treating physician, the patient has adequate organ function to tolerate GaM. 4. Patient must be able to swallow and retain orally administered medication. 5. For females of childbearing potential, negative urinary or serum pregnancy test. 6. 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. 7. 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. 8. 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. 9. Informed consent obtained for the XCELSIOR longitudinal outcomes registry (NCT03793088) Exclusion Criteria: 1. Patient is already participating in or is able to enroll in a clinical trial of GaM. 2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting GaM treatment, whichever is shorter. 3. Patients completing radiotherapy treatment less than 14 days prior to planned study treatment initiation. 4. Patient is taking oral iron supplements or iron chelators. 5. 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. 6. 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. 7. Known hypersensitivity to GaM or any component in its formulation. 8. Patients taking prohibited medications as described in the current Investigator's Brochure. 9. Patient is pregnant or actively breastfeeding
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Partners of Nebraska
AVAILABLELincoln, Nebraska, 68516, United States
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Northwell Health
AVAILABLENew York, New York, 10075, United States
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University of Miami Sylvester Comprehensive Cancer Center
AVAILABLEMiami, Florida, 33136, United States
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