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Kinase Inhibitor

Selumetinib for Plexiform Neurofibromas (KOMET Trial)

Phase 3
Waitlist Available
Led By Alice P. Chen, MD
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults ≥ 18 years at enrollment with diagnosis of NF1 with symptomatic, inoperable PN
At least one inoperable target PN measurable by volumetric MRI analysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 3 years
Awards & highlights

KOMET Trial Summary

This trial will test whether selumetinib can shrink plexiform neurofibromas in people with NF1.

Who is the study for?
Adults over 18 with Neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas can join. They must have stable pain medication use, measurable tumors by MRI, and proper organ/marrow function. Excluded are those with certain malignancies or severe heart disease.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Selumetinib versus a placebo in adults with NF1 who have painful and inoperable plexiform neurofibromas to see if it helps reduce symptoms.See study design
What are the potential side effects?
Selumetinib may cause side effects like skin rash, eye problems, heart issues, muscle pain, fatigue, nausea/vomiting. The severity varies from person to person.

KOMET Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 or older with NF1 and have a tumor that can't be surgically removed.
Select...
I have a tumor that cannot be removed by surgery and can be measured by MRI.
Select...
My pain medication for chronic peripheral neuropathy has been stable.

KOMET Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Confirmed Objective Response Rate (ORR) for Arm A versus Arm B
Secondary outcome measures
Pain
Upper arm
Health Related Quality of Life (HRQoL) outcomes assessed using PlexiQoL
+5 more
Other outcome measures
Pharmacokinetics (PK) of selumetinib for exposure-response analyses
Safety and tolerability of selumetinib as assessed by number and grade of adverse events

Side effects data

From 2012 Phase 2 trial • 37 Patients • NCT01085214
75%
Diarrhea
50%
Fatigue
47%
Anemia
47%
Rash acneiform
44%
Hypoalbuminemia
44%
Edema, limbs
39%
Aspartate aminotransferase increased
33%
Neutrophil count decreased
33%
White blood cell decreased
31%
Nausea
31%
Vomiting
28%
Platelet count decreased
25%
CPK increased
25%
Hypomagnesemia
22%
Hypertension
19%
Hypophosphatemia
19%
Hypocalcemia
19%
Hyponatremia
19%
Edema, face
17%
Dry skin
17%
Alanine aminotransferase increased
14%
Skin and subcutaneous tissue disorders - Other
14%
Hypokalemia
14%
Creatinine increased
14%
Back pain
14%
Dyspnea
14%
Lymphocyte count decreased
11%
Pain
11%
Fever
11%
Localized edema
11%
Peripheral sensory neuropathy
11%
Hyperkalemia
11%
Dizziness
11%
Abdominal pain
8%
Hypoglycemia
8%
Acute kidney injury
8%
Anorexia
8%
Death, NOS
8%
Periorbital edema
8%
Skin hypopigmentation
8%
Pain in extremity
8%
Cough
8%
Insomnia
8%
Alkaline phosphatase increased
8%
Dry mouth
8%
Sepsis
6%
Renal and urinary disorders - Other
6%
Dehydration
6%
Musculoskeletal and connective tissue disorder - Other, Rhabdomyolysis
6%
Hypernatremia
6%
Blood and lymphatic system disorders - Other
6%
Hypercalcemia
6%
Metabolism and nutrition disorders - Other
6%
Chills
6%
Hypotension
6%
Myalgia
6%
Arthralgia
6%
Upper respiratory infection
6%
Headache
6%
Sinusitis
6%
Generalized muscle weakness
6%
Gastrointestinal disorders - Other
6%
Gastroesophageal reflux disease
3%
Confusion
3%
Vaginal inflammation
3%
Pruritus
3%
Febrile neutropenia
3%
Flu like symptoms
3%
Hepatic failure
3%
Skin infection
3%
Fall
3%
Fracture
3%
Skin and subcutaneous tissue disorders - Other, Angular cheilitis, unilateral
3%
Adult respiratory distress syndrome
3%
Renal and urinary disorders - Other, Acute renal failure
3%
INR increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
AZD6244 (Selumetinib) Treatment

KOMET Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment1 Intervention
Selumetinib
Group II: Arm BPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2050

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,260 Previous Clinical Trials
288,594,006 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,887 Previous Clinical Trials
5,054,511 Total Patients Enrolled
Alice P. Chen, MDPrincipal InvestigatorNational Cancer Institute (NCI)

Media Library

Selumetinib (Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04924608 — Phase 3
Neurofibromatosis Research Study Groups: Arm B, Arm A
Neurofibromatosis Clinical Trial 2023: Selumetinib Highlights & Side Effects. Trial Name: NCT04924608 — Phase 3
Selumetinib (Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04924608 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are the findings of this study corroborated by prior research on Selumetinib?

"Selumetinib was first studied in 2007 and, since then, 18297 clinical trials have completed. Right now, 35 trials are ongoing with a large number of them based in Saint Louis, Missouri."

Answered by AI

Has Selumetinib been cleared by the FDA for patient use?

"Selumetinib's safety has been well documented in past Phase 3 trials, thus it received a score of 3."

Answered by AI

Are there any patients currently needed for this clinical trial?

"Yes, this information is available on the website clinicaltrials.gov. The trial was created on 2021-11-19 and updated on 2022-10-04."

Answered by AI

What is the objective of this research?

"The primary outcome that will be measured over the course of approximately 3 years is the Confirmed Objective Response Rate (ORR) for Arm A versus Arm B. Additionally, this trial will evaluate secondary outcomes including Change in chronic target PN pain intensity from baseline for Arm A versus Arm B as assessed using a PRO questionnaire, Target PN volume for Arm A vs Arm B, and Time to progression (TTP) for Arm A."

Answered by AI

Have there been other studies like this one before?

"There are 35 concurrent trials worldwide for Selumetinib. The first one was sponsored by AstraZeneca in 2007 and completed Phase 1 drug approval with 58 participants. Since then, there have been 18297 more trials."

Answered by AI

What is the total sample size for this research project?

"Yes, the information on clinicaltrials.gov suggests that this study is actively recruiting candidates. The trial was originally posted on 2021-11-19 and was most recently edited on 2022-10-04. The study is looking for 146 patients across 7 locations."

Answered by AI

Who else is applying?

What state do they live in?
Georgia
What site did they apply to?
Research Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas
2021. "Efficacy and Safety of Selumetinib in Adults With NF1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04924608.
All > Neurofibromatosis Type 1 > Neurofibromatosis
~14 spots leftby Aug 2024
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