Ignite Creation Date:
2024-05-06 @ 4:21 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04967690
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-07-06
First Post:
2021-06-30
Brief Title:
A Dose Escalation Study to Estimate MTD DLTs and Pharmacokinetics After a Single Intracranial Dose of SI-053 as an add-on to the Current Standard of Care in Adult Patients With Newly Diagnosed GBM
Sponsor:
Double Bond Pharmaceutical AB
Organization:
Double Bond Pharmaceutical AB
Study Overview
Official Title:
An Open-label Dose Escalation Study to Estimate MTD Identify DLTs and Study Pharmacokinetics Following a Single Dose of Intracranially Administered Temozolomide-based SI-053 as an add-on to the Current Standard of Care in Adult Patients With Newly Diagnosed Glioblastoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-07
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:
TARGLIO
Brief Summary:
SI-053 is a novel powder formulation containing temozolomide TMZ an alkylating chemotherapy agent in an excipient which forms a viscous gel upon reconstitution in water SI-053 will be used as an add-on to SoC for newly diagnosed GBM SoC consists of maximal safe resection followed by radiation therapy RT with concomitant TMZ and adjuvant chemotherapy with TMZ For MGMT promoter methylated GBM lomustine and TMZ may be administered plus radiation therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None