Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2026-02-18 @ 12:56 AM
Study NCT ID:
NCT03627403
Status:
TERMINATED
Last Update Posted:
2025-06-19
First Post:
2018-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Selinexor in Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors
Sponsor:
University of Utah
Organization:
Study Overview
Official Title:
A Phase II Study to Evaluate the Efficacy and Safety of Selinexor in Patients With Myelofibrosis Refractory or Intolerant to JAK1/2 Inhibitors
Status:
TERMINATED
Status Verified Date:
2025-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI and Sponsor decision. Accrual was low and there was sufficient data to detect a response.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ESSENTIAL
Brief Summary:
This is a phase II, open label, prospective, single-arm study evaluating the efficacy and safety of selinexor in patients with PMF or secondary MF (PPV-MF or PET-MF) who are refractory or intolerant to ruxolitinib and/or any other experimental JAK1/2 inhibitors.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: