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
This trial does not accept healthy volunteersQualifiers
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
DrugGaM will be provided as 500 mg capsules and will be self-administered once daily by mouth at the assigned dose level on a 28-day cycle (one cycle is 28 days) on an empty stomach. GaM should be taken at least 60 minutes before a meal and at least two hours after a meal. Liquids are allowed
Treatment groups
No treatment groups listed
Trial outcomes
This trial has no outcomes listed.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Imaging Biometrics, LLC
Lead sponsor
xCures
Collaborator
Source ClinicalTrials.gov