At a glance
ClinicalIndex Comparison RecordPhase 3Active· 145 enrolled
Drug / intervention
Selumetinib +1 moredrug
Likely dose
Selumetinib oral capsules (10 mg and 25 mg)AI-extracted
Key inclusion· 5
- ✓Adults ≥18 years old with NF1 diagnosis and symptomatic, inoperable plexiform neurofibroma
- ✓At least one inoperable target plexiform neurofibroma measurable by volumetric MRI
- ✓Chronic target plexiform neurofibroma pain score documented during screening period
- ✓Stable chronic plexiform neurofibroma pain medication use at enrollment
Key exclusion· 5
- ✕Confirmed or suspected malignant glioma or MPNST (low-grade glioma and optic glioma not requiring treatment are exempt)
- ✕History of malignancy except those treated with curative intent with no active disease ≥5 years prior and low recurrence risk
- ✕Clinically significant cardiovascular disease including acute coronary syndrome within 6 months, uncontrolled angina, heart failure, cardiomyopathy, severe valvular disease, abnormal LVEF, or uncontrolled hypertension
- ✕Ophthalmological abnormalities including intraocular pressure >21 mmHg, retinal pigment epithelial detachment/central serous retinopathy, or retinal vein occlusion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Selumetinib and Placebo for Neurofibromatosis 1 and Plexiform Neurofibroma (PN). Active but no longer recruiting, targeting 145 participants across 34 sites in 13 countries.
Detailed Summary
A global study to demonstrate the effectiveness of selumetinib in participants with NF1 who have symptomatic, inoperable plexiform neurofibromas.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurofibromatosis 1, Plexiform Neurofibroma (PN)
CountriesAustralia, Brazil, Canada, China, France, Germany, Italy, Japan, Poland, Russia, Spain, United Kingdom, United States
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 3Active
20222023202420252026202720282029
First PostedJun 2021
Enrollment StartNov 2021
Primary CompletionAug 2024
TodayJul 2026
Study CompletionFeb 2029
First PostedJun 14, 2021
Enrollment StartNov 19, 2021
Primary CompletionAug 5, 2024
Study CompletionFeb 15, 2029
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 5.0 years ago
Interventions
Selumetinibdrug
Selumetinib oral capsules (10 mg and 25 mg)
Placeboother
Placebo oral capsules for Selumetinib masking (10 mg and 25 mg)