Expanded Access to Gallium Maltolate (GaM) for Adult Patients With Relapsed/Refractory Histologic or Molecular Glioblastoma

Trial ID: NCT06404034

Interventional - Phase Unknown - Available

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

Conditions

• Glioblastoma
• Refractory Glioblastoma
• Glioblastoma Multiforme

Interventions

• Gallium Maltolate

Eligibility

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

Sponsor

Imaging Biometrics, LLC, xCures

Source: ClinicalTrials.gov

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