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MEK Inhibitor
Trametinib for Cancer With NF1 Genetic Changes
Phase 2
Waitlist Available
Led By Jason J Luke
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
Patients must have deleterious inactivating mutations of NF-1, or another aberration, as determined via the MATCH Master Protocol
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Awards & highlights
Study Summary
This trial is testing the effects of trametinib on patients with cancer that has a NF1 mutation. Trametinib blocks proteins that may be needed for cancer cell growth. Researchers hope to learn if trametinib will shrink or stop the growth of this type of cancer.
Who is the study for?
This trial is for cancer patients with a specific genetic change called NF1 mutation. They must have normal heart function, controlled blood pressure, and no history of severe lung disease or eye problems. Those who've had certain monoclonal antibody therapies or MEK inhibitors are excluded.Check my eligibility
What is being tested?
Researchers are testing Trametinib to see if it can shrink tumors or halt their growth in cancers with the NF1 mutation. Trametinib targets proteins that may be essential for the growth of these cancer cells.See study design
What are the potential side effects?
Trametinib may cause side effects such as skin rash, diarrhea, fatigue, and possibly affect heart function. It's also important to watch out for signs of lung issues since patients with a history of lung disease aren't eligible.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a specific genetic change related to NF-1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles for the first 26 cycles and every 3 cycles thereafter until disease progression, up to 3 years post registration
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR)
Secondary outcome measures
6-month Progression-free Survival (PFS) Rate
Progression Free Survival (PFS)
Side effects data
From 2018 Phase 2 trial • 9 Patients • NCT02281760100%
Chills
100%
Rash
100%
Hyperthermia
100%
Anaemia
83%
Dehydration
67%
Fatigue
67%
Blood urea increased
67%
Lipase increased
67%
Headache
50%
Nausea
50%
Blood creatinine increased
50%
Blood cholesterol increased
50%
Hyponatraemia
50%
Diarrhoea
50%
Back pain
50%
Pain in extremity
50%
Amylase increased
50%
Blood creatine phosphokinase increased
33%
Dyspepsia
33%
Aspartate aminotransferase increased
33%
Blood pressure increased
33%
Myalgia
33%
Red blood cells urine
33%
Alanine aminotransferase increased
33%
Hypotension
33%
Labile hypertension
33%
Hypertension
33%
Hypertriglyceridaemia
33%
Blood alkaline phosphatase increased
33%
Ataxia
33%
Abdominal pain
33%
Urinary tract infection
33%
Cough
33%
Malaise
33%
Vomiting
33%
Disturbance in attention
17%
Arthralgia
17%
Syncope
17%
Vertigo
17%
Arthritis
17%
Penile pain
17%
Gamma-glutamyltransferase increased
17%
Memory impairment
17%
Gingival recession
17%
Paronychia
17%
Viral infection
17%
Prothrombin time prolonged
17%
Leukopenia
17%
Erythema nodosum
17%
Hypernatraemia
17%
Sweating fever
17%
Hyperglycaemia
17%
Lip dry
17%
Lymphadenopathy
17%
Acute kidney injury
17%
Pharyngitis
17%
Urosepsis
17%
Nasal congestion
17%
Hypomagnesaemia
17%
Blood thyroid stimulating hormone decreased
17%
Cystatin C increased
17%
Anorexia nervosa
17%
Skin sensitisation
17%
Joint effusion
17%
Confusional state
17%
Proteinuria
17%
Dyspnoea
17%
Hyperuricaemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Combination Therapy With Dabrafenib and Trametinib in Patients With ECD
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib)Experimental Treatment1 Intervention
Patients receive trametinib dimethyl sulfoxide PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib Dimethyl Sulfoxide
2014
Completed Phase 2
~10
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,103 Total Patients Enrolled
Jason J LukePrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has a specific genetic change related to NF-1.I am not allergic to trametinib, similar drugs, or DMSO.Criterion: You need to have had an ECG and an echocardiogram or nuclear study recently to make sure your heart is healthy. You also can't have certain heart conditions or high blood pressure that can't be controlled with medication. If you've had certain antibody treatments in the past, you need to wait a while before starting this treatment. If you have glioblastoma, it needs to be confirmed that your cancer has come back. All tests for assessing your disease must use special imaging techniques.I have never had interstitial lung disease or pneumonitis.I don't have, nor am I at risk for, a blocked vein in my eye.I have not taken any MEK inhibitor medications.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (trametinib)
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.
How many volunteers are a part of this research?
"This particular study is no longer looking for candidates, as the most recent update was on September 14th, 2022. However, there are presently 4811 clinical trials actively recruiting patients with neoplasms and 96 studies for Trametinib Dimethyl Sulfoxide admitting patients."
Answered by AI
Has the FDA greenlit Trametinib Dimethyl Sulfoxide for patient use?
"While there is data supporting the safety of Trametinib Dimethyl Sulfoxide, it only received a 2 because there is no evidence yet that the drug is effective."
Answered by AI
Are there other examples of Trametinib Dimethyl Sulfoxide being tested in a clinical setting?
"As of this moment, 96 clinical trials for Trametinib Dimethyl Sulfoxide are ongoing with 6 in Phase 3. Out of these studies, several will soon conclude in Saint Lewis, Missouri; however, 5799 other locations around the world are also running trials for Trametinib Dimethyl Sulfoxide."
Answered by AI
Are researchers actively looking for participants for this clinical trial?
"The clinical trial in question is no longer recruiting patients, as reflected on clinicaltrials.gov. This particular study was posted on February 25th, 2016 and updated September 14th, 2020. There are 4907 other trials that are currently looking for participants."
Answered by AI
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