Ignite Creation Date:
2024-05-06 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 12:54 PM
Study NCT ID:
NCT03687034
Status:
UNKNOWN
Last Update Posted:
2019-02-26
First Post:
2018-08-22
Brief Title:
A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma
Sponsor:
Leaf Vertical Inc
Organization:
Leaf Vertical Inc
Study Overview
Official Title:
A Phase I Study of BRCX014 to Investigate Dose-Ranging Safety and Pharmacokinetics in Adults With Glioblastoma GBM and Non-Methylated MGMT Gene Status
Status:
UNKNOWN
Status Verified Date:
2019-02
Last Known Status:
NOT_YET_RECRUITING
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:
An Open-Label Multi-Center Study to Assess the Safety and Pharmacokinetics of BRCX014 Combined with Standard-of-Care Treatment in Subjects with Glioblastoma
Detailed Description:
Several studies have shown a possible anti-tumor role for cannabinoids by modulating cell signaling pathways inhibiting angiogenesis inducing apoptosis and overcoming chemotherapy resistance The investigators seek to demonstrate the safety profile of BRCX014 a cannabinoid formulation when given to glioblastoma patients in conjunction with standard-of-care therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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