Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06404034
Status:
AVAILABLE
Last Update Posted:
2024-06-13
First Post:
2024-05-02
Brief Title:
Expanded Access to Gallium Maltolate GaM
Sponsor:
Imaging Biometrics LLC
Organization:
Imaging Biometrics LLC
Study Overview
Official Title:
Expanded Access to Gallium Maltolate GaM for Adult Patients With RelapsedRefractory Histologic or Molecular Glioblastoma
Status:
AVAILABLE
Status Verified Date:
2024-09
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 relapsedrefractory 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 relapsedrefractory 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 relapsedrefractory 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 physicians discretion additional medications 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 physicians discretion additional medications 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None