Expanded Access to Gallium Maltolate (GaM) for Patients with Relapsed or Hard-to-Treat Glioblastoma

Sponsor: Imaging Biometrics, LLC

Expanded Access
Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06404034

Provider View

This program offers Gallium Maltolate (GaM) to adults with glioblastoma that has returned or is difficult to treat, who have no other treatment options available.

Patient Parameters

Program Overview

The goal of this program is to provide Gallium Maltolate (GaM) to adults aged 18 and older with glioblastoma that has come back or is resistant to treatment. Glioblastoma is a type of brain cancer, and this program is for those who have tried all other available treatments. The program follows specific criteria to identify eligible patients based on the characteristics of their cancer, such as certain genetic markers or changes in the tumor.

Description

This program allows patients to access Gallium Maltolate (GaM) as a treatment option. GaM is provided in 500 mg capsules, which patients take by mouth once a day on an empty stomach. The treatment is given in 28-day cycles, and initially, patients receive enough medication for three cycles. After this period, more GaM can be provided for continued use at home.

Patients can stop taking GaM at any time for any reason, and their doctor can also decide to stop the treatment if needed. Other supportive care treatments for cancer are allowed, but any additional cancer treatments require consultation with the program coordinators. Patients and their doctors can discuss any changes to the treatment schedule or the addition of other therapies with the program coordinators.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with glioblastoma that has returned or is hard to treat.
  • The doctor believes the patient might benefit from GaM treatment.
  • The patient has good organ function to handle GaM.
  • The patient can swallow pills.
  • Women of childbearing age must have a negative pregnancy test.
  • Patients must agree to use effective birth control during treatment and for 4 months after.
  • Any side effects from previous treatments are stable or not significant.
  • The patient can understand and sign a consent form, or a representative can do so.
  • Consent is given for participation in a related outcomes registry study.

Exclusion Criteria

  • Currently in or eligible for a clinical trial of GaM.
  • Recently received another investigational treatment.
  • Finished radiation therapy less than 14 days before starting GaM.
  • Taking iron supplements or medications that affect iron levels.
  • Have a serious illness that makes GaM treatment unsafe.
  • Not fully recovered from recent major surgery.
  • Allergic to GaM or its ingredients.
  • Taking medications that are not allowed with GaM.
  • Pregnant or breastfeeding.

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