Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-31 @ 6:35 PM
Study NCT ID:
NCT05980806
Status:
RECRUITING
Last Update Posted:
2025-02-05
First Post:
2023-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Sponsor:
Karyopharm Therapeutics Inc
Organization:
Study Overview
Official Title:
A Phase 2 Study to Evaluate the Efficacy and Safety of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia
Status:
RECRUITING
Status Verified Date:
2025-02
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:
SENTRY-2
Brief Summary:
The main purpose of this study with corresponding optional expansion is to evaluate the efficacy of selinexor in JAKi-naïve participants with myelofibrosis (MF) and moderate thrombocytopenia based on spleen volume reduction (SVR). Additional efficacy and safety parameters will also be assessed during the study.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: