Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-26 @ 5:35 PM
Study NCT ID:
NCT06404034
Status:
AVAILABLE
Last Update Posted:
2025-07-31
First Post:
2024-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to Gallium Maltolate (GaM)
Sponsor:
Imaging Biometrics, LLC
Organization:
Study Overview
Official Title:
Expanded Access to Gallium Maltolate (GaM) for Adult Patients With Relapsed/Refractory Histologic or Molecular Glioblastoma
Status:
AVAILABLE
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: