Ignite Creation Date:
2024-05-06 @ 10:08 AM
Last Modification Date:
2024-10-26 @ 12:25 PM
Study NCT ID:
NCT03173248
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-05
First Post:
2017-05-30
Brief Title:
Study of AG-120 Ivosidenib vs Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Sponsor:
Institut de Recherches Internationales Servier
Organization:
Servier
Study Overview
Official Title:
A Phase 3 Multicenter Double-Blind Randomized Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
AGILE
Brief Summary:
Study AG120-C-009 is a global Phase 3 multicenter double-blind randomized placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 ivosidenib azacitidine vs placebo azacitidine in adult participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy The primary endpoint is event-free survival EFS The key secondary efficacy endpoints are overall survival OS rate of complete remission CR rate of CR and complete remission with partial hematologic recovery CRh and overall response rate ORR Participants eligible for study treatment based on Screening assessments will be randomized 11 to receive oral AG-120 or matched placebo both administered in combination with subcutaneous SC or intravenous IV azacitidine An estimated 200 participants will take part in the study
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