Ignite Creation Date:
2024-05-06 @ 4:15 PM
Last Modification Date:
2024-10-26 @ 2:06 PM
Study NCT ID:
NCT04924608
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2021-05-14
Brief Title:
Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic Inoperable Plexiform Neurofibromas
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
A Phase III Multicentre International Study With a Parallel Randomised Double-blind Placebo-controlled 2 Arm Design to Assess the Efficacy and Safety of Selumetinib in Adult Participants With NF1 Who Have Symptomatic Inoperable Plexiform Neurofibromas KOMET
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:
KOMET
Brief Summary:
A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic inoperable plexiform neurofibromas
Detailed Description:
This is a randomized double-blind placebo-controlled 2 arm multicentre global Phase III study to assess the efficacy and safety of selumetinib compared with placebo in adult participants with NF1 who have symptomatic inoperable PN
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-005607-39 | EUDRACT_NUMBER | None | None |