Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-25 @ 7:35 PM
Study NCT ID:
NCT07215832
Status:
AVAILABLE
Last Update Posted:
2025-10-14
First Post:
2025-09-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Karyopharm Expanded Access Program for Selinexor
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Study Overview
Official Title:
Karyopharm Expanded Access Program for Selinexor
Status:
AVAILABLE
Status Verified Date:
2025-09
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:
KEAP
Brief Summary:
KEAP is an expanded access program designed to provide selinexor to eligible participants outside of a clinical trial before the drug has been given marketing approval by the country's regulatory agency or the drug is commercially available in the country. Patients who do not qualify for an ongoing clinical trial but who might benefit from the investigational medicine may be eligible, provided they have exhausted all other available treatment options. Investigational medicines are provided to patients only through treating physicians who obtain the relevant approval on behalf of their patient from the relevant regulatory agency and follow all applicable safety-reporting regulations of the respective country.
Detailed Description:
None
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?: