Expanded Access to Gallium Maltolate (GaM)
Trial statusAvailable
Trial phaseNot listed
Trial typeExpanded Access
Biological sexAll
Age18+
SponsorImaging Biometrics, LLC
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Gallium Maltolate
Treatment groups
No treatment groups listed
Sponsors and collaborators
Imaging Biometrics, LLC
Lead sponsor
xCures
Collaborator
Source ClinicalTrials.gov