Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04566393
Status:
AVAILABLE
Last Update Posted:
2024-07-03
First Post:
2020-09-17
Brief Title:
Expanded Access to Ulixertinib BVD-523 in Patients with Advanced MAPK Pathway-Altered Malignancies
Sponsor:
xCures
Organization:
xCures
Study Overview
Official Title:
Expanded Access to Ulixertinib BVD-523 in Patients with Advanced MAPK Pathway-Altered Malignancies
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 expanded access program is to provide ulixertinib BVD-523 for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumors including but not limited to KRAS NRAS HRAS BRAF MEK and ERK mutations who have incomplete response to or have exhausted available therapies
Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agents conditionally approved by the drug manufacturer
Ulixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agents conditionally approved by the drug manufacturer
Detailed Description:
None
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