Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619522
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
A Phase 2 Study of INCB57643 BET Inhibitor in Combination With Ruxolitinib in JAK Inhibitor-naïve Patients With Myelofibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2 Study of INCB57643 BET Inhibitor in Combination With Ruxolitinib in JAK Inhibitor-naïve Patients With Myelofibrosis
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess INCB05643 ruxolitinib JAKi-naive patients with myelofibrosis
Detailed Description:
Primary Objective
To evaluate splenic response rate by imaging after 24 weeks of treatment
Secondary Objectives
To evaluate splenic response rate by imaging after 24 weeks of treatment To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate the overall splenic response rate and the duration of splenic response To evaluate the overall splenic response rate and the duration of splenic response To evaluate the proportion of patients who achieve both a splenic response and a 50 reduction in TSS after 24 weeks of treatment
To evaluate splenic response rate by imaging after 24 weeks of treatment
Secondary Objectives
To evaluate splenic response rate by imaging after 24 weeks of treatment To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate splenic response rate by imaging after 12 weeks of treatment To evaluate the overall splenic response rate and the duration of splenic response To evaluate the overall splenic response rate and the duration of splenic response To evaluate the proportion of patients who achieve both a splenic response and a 50 reduction in TSS after 24 weeks of treatment
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