The objective of this program is to provide GaM for compassionate use in patients withrelapsed/refractory histologic or molecular glioblastoma who have exhausted availabletreatments.The population of this program is adult patients aged greater than or equal to 18 yearswith a diagnosis of relapsed/refractory histologic or molecular glioblastoma, accordingto the WHO 2021 diagnostic criteria.Molecular glioblastoma is characterized as an IDH-wildtype diffuse and astrocytic gliomain adults if there is microvascular proliferation or necrosis or TERT promoter mutationor EGFR gene amplification or +7/-10 chromosome copy number changes
This is an intermediate-sized expanded access treatment protocol. GaM (GaM) 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). Initially, the patients
will be provided a three (3) cycle prescription (a 28-day supply with two refills);
enough total supply of GaM for three full cycles to allow for self-administration at
home. It should be taken on an empty stomach. After that initial period, subsequent GaM
will be provided to patients for continued self-administration.
At the treating physician's discretion, additional medication(s) may be administered.
Clinical use of cancer-supportive care therapies is unrestricted, but the non-emergent
use of additional anti-cancer therapies requires prior consultation with xCures and
Imaging Biometrics. xCures along with Imaging Biometrics will be consulted prior to the
non-emergent administration of any additional anti-cancer medications. xCures, along with
Imaging Biometrics, should be consulted prior to any schedule modifications or the
addition of other therapy. The patients may discontinue therapy at any time for any
reason. The treating physician can discontinue therapy with GaM at any time for any
reason.
Drug: Gallium Maltolate
GaM 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
Other Name: GaM
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
Leonard Cancer Institute at Providence Mission Hospital
Mission Viejo, California, United States
Northwell Health
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
xCures Inc.
(707) 641-4475
expandedaccess@xcures.com
Imaging Biometrics, Inc.
262-439-8252
eap@imagingbiometrics.com
Not Provided