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MAPK/ERK Kinase Inhibitor
Selumetinib for Cancer
Phase 2
Waitlist Available
Led By Carl E Allen
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have enrolled onto APEC1621SC and must have been given a treatment assignment to molecular analysis for therapy choice (MATCH) to APEC1621E based on the presence of an actionable mutation
Patients must have a body surface area >= 0.5 m^2 at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4.5 years
Awards & highlights
Study Summary
This trial studies selumetinib sulfate in treating patients with solid tumors, non-Hodgkin lymphoma, or histiocytic disorders.
Who is the study for?
This trial is for patients with advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders that have MAPK pathway mutations and are not responding to treatment. Participants must be able to swallow capsules, have a body surface area >= 0.5 m^2, and meet specific health criteria including organ function and blood counts. Pregnant women or those on certain medications cannot join.Check my eligibility
What is being tested?
The study tests Selumetinib Sulfate's effectiveness in treating relapsed or refractory cancers with MAPK mutations. It's a phase II trial aiming to see if this drug can halt cancer cell growth by inhibiting necessary enzymes.See study design
What are the potential side effects?
Selumetinib may cause side effects such as fatigue, rash, nausea, vomiting, diarrhea, abdominal pain, visual changes and increased blood pressure. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am enrolled in APEC1621SC and assigned to MATCH based on a specific mutation in my cancer.
Select...
My body surface area is at least 0.5 square meters.
Select...
I am mostly able to care for myself and carry out daily activities.
Select...
I have never been treated with selumetinib.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4.5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4.5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Response Rate
Secondary outcome measures
Percentage of Participants With Treatment-related Adverse Events as Accessed by Common Terminology Criteria for Adverse Events (CTCAE) Version (v) 5.0
Progression Free Survival (PFS)
Other outcome measures
Biomarker Analysis as Predictors of Response to Selumetinib
Changes in Tumor Genomic Profile
Side effects data
From 2020 Phase 2 trial • 8 Patients • NCT03040986100%
Aspartate aminotransferase increased
83%
Edema limbs
83%
Hypoalbuminemia
67%
Hypertension
67%
Fatigue
50%
Nausea
50%
Alkaline phosphatase increased
50%
Anorexia
50%
Anemia
50%
Abdominal pain
50%
Alanine aminotransferase increased
50%
Dyspnea
33%
Dizziness
33%
Generalized muscle weakness
33%
Hypocalcemia
33%
Hyponatremia
33%
Lymphocyte count decreased
33%
Rash maculo-papular
33%
Hypokalemia
33%
Bloating
33%
CPK increased
33%
Cough
33%
Creatinine increased
33%
Vomiting
17%
Alopecia
17%
Atelectasis
17%
Gallbladder infection
17%
Dysphagia
17%
Edema trunk
17%
Lipase increased
17%
Serum amylase increased
17%
Glucose intolerance
17%
Dry mouth
17%
Colonic obstruction
17%
Gallbladder obstruction
17%
Confusion
17%
Pancreatitis
17%
Diarrhea
17%
Dysgeusia
17%
Heart failure
17%
Ascites
17%
Hyperglycemia
17%
Weight loss
17%
White blood cell decreased
17%
Hypomagnesemia
17%
Hypotension
17%
Malaise
17%
Neck pain
17%
Pleural effusion
17%
Postnasal drip
17%
Renal and urinary disorders - Other, Dysuria
17%
Rash acneiform
17%
Neutrophil count decreased
17%
Paresthesia
17%
Peritoneal infection
17%
Back pain
17%
Biliary tract infection
17%
Blood bilirubin increased
17%
Fever
17%
Sore throat
17%
Urinary tract obstruction
17%
Musculoskeletal and connective tissue disorder - Other, muscle spasm
17%
Urine discoloration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Level 0: 75mg Selumetinib Sulfate Twice Daily
75mg Selumetinib Sulfate Twice Daily Follow/by 50mg TwiceDaily
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (selumetinib)Experimental Treatment3 Interventions
Patients receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Selumetinib
2010
Completed Phase 2
~2050
Selumetinib Sulfate
2017
Completed Phase 2
~80
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,132 Total Patients Enrolled
Carl E AllenPrincipal InvestigatorChildren's Oncology Group
1 Previous Clinical Trials
28 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have recovered from side effects of my previous cancer treatments.My stem cell treatment followed the required time guidelines.My cancer has a specific BRAF V600 mutation.My cancer can be seen and measured on scans, or it shows up on special scans for neuroblastoma.I am currently taking other medications.I do not have any infections that are currently uncontrolled.I am enrolled in APEC1621SC and assigned to MATCH based on a specific mutation in my cancer.I am not taking medication that strongly affects how my body processes drugs.My body surface area is at least 0.5 square meters.My organs are functioning well.You have had an organ transplant in the past.Your blood counts must be within a certain range.I have been diagnosed with a low grade glioma.I am mostly able to care for myself and carry out daily activities.I have never been treated with selumetinib.You have serious eye problems.I am taking medication to prevent graft-versus-host disease after a transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (selumetinib)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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