Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04551053
Status:
TERMINATED
Last Update Posted:
2024-05-10
First Post:
2020-09-11
Brief Title:
To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib LIMBER-304
Sponsor:
Incyte Corporation
Organization:
Incyte Corporation
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Study of the PI3Kδ Inhibitor Parsaclisib Plus Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated due to futility
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to compare the efficacy and safety of parsaclisib when combined with ruxolitinb versus placebo combined with ruxolitinib in participants with myelofibrosis who have suboptimal response while receiving ruxolitinib monotherapy
Detailed Description:
Prospective participants must be on stable doses of ruxolitinib ranging from 5 mg BID to 25 mg BID and will have been on that dose for at least the last 8 weeks prior to Day 1 At least 3 months duration of prior ruxolitinib is required Participants must meet Protocol-defined criteria for suboptimal response to ruxolitinib monotherapy After participants have been determined to be eligible for the study and completed the baseline symptom diary assessment for 7 days they will be randomized to 1 of 2 treatment groups with stratification for platelet count 100 109L vs 50 to 100 109L inclusive and DIPSS risk category high vs intermediate-2 vs intermediate-1
Once a participant has completed the week 24 assessments the participants treatment assignment will then be unblinded and if found to be placebo the participant will have the opportunity to crossover to begin receiving parsaclisib together with continued ruxolitinib as long as hematology parameters are adequate
Once a participant has completed the week 24 assessments the participants treatment assignment will then be unblinded and if found to be placebo the participant will have the opportunity to crossover to begin receiving parsaclisib together with continued ruxolitinib as long as hematology parameters are adequate
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