Ignite Creation Date:
2024-07-17 @ 11:04 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479135
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-21
Brief Title:
Study of Navtemadlin add-on to Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Sponsor:
Kartos Therapeutics Inc
Organization:
Kartos Therapeutics Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in JAK Inhibitor-Naïve Patients With Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
Status:
RECRUITING
Status Verified Date:
2024-06
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:
POIESIS
Brief Summary:
This clinical trial is evaluating whether addition of navtemadlin to ruxolitinib treatment will provide more clinical benefit than ruxolitinib alone for patients with Myelofibrosis who have a suboptimal response to ruxolitinib treatment alone
Subjects will start by receiving ruxolitinib alone in the run-in period Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 21 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib Randomized means that subjects will be assigned to a group by chance like a flip of a coin The study is blinded meaning the subjects doctors central endpoint assessors and sponsor will not know which add on treatment navtemadlin or navtemadlin placebo the subject is receiving
Subjects will start by receiving ruxolitinib alone in the run-in period Those who demostrate a suboptimal response from ruxolitinib alone will then be randomized 21 to receive navtemadlin or navtemadlin placebo as add-on treatment to their ongoing ruxolitinib Randomized means that subjects will be assigned to a group by chance like a flip of a coin The study is blinded meaning the subjects doctors central endpoint assessors and sponsor will not know which add on treatment navtemadlin or navtemadlin placebo the subject is receiving
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None