Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT06404034
Eligibility Criteria:
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
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06404034
Study Brief:
Protocol Section:
NCT06404034