Trials / Active Not Recruiting
Active Not RecruitingNCT04924608
Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
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
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 145 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Selumetinib | Selumetinib oral capsules (10 mg and 25 mg) |
| OTHER | Placebo | Placebo oral capsules for Selumetinib masking (10 mg and 25 mg) |
Timeline
- Start date
- 2021-11-19
- Primary completion
- 2024-08-05
- Completion
- 2029-02-15
- First posted
- 2021-06-14
- Last updated
- 2026-03-23
- Results posted
- 2025-10-20
Locations
34 sites across 13 countries: United States, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Poland, Russia, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04924608. Inclusion in this directory is not an endorsement.