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MEK Inhibitor
Trametinib for Cancer
Phase 2
Waitlist Available
Led By Douglas B Johnson
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 a BRAF non-V600 mutation or BRAF fusion, or another aberration, as identified 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 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 have BRAF mutations. Trametinib may block proteins that are needed for growth of cancer cells. Researchers hope to learn if giving trametinib will shrink or stop the growth of this type of cancer.
Who is the study for?
This trial is for cancer patients with specific BRAF genetic changes who've met prior MATCH Protocol criteria. They need a normal heart rhythm, controlled blood pressure, and adequate heart function shown by recent tests. Those treated with monoclonal antibodies must have stopped them 8+ weeks before starting trametinib.Check my eligibility
What is being tested?
The study is testing Trametinib's effectiveness on cancers with BRAF mutations. It aims to see if the drug, which blocks certain proteins (MEK1/2) needed by these cancer cells, can shrink or halt their growth.See study design
What are the potential side effects?
Potential side effects of Trametinib include vision problems like retinal vein occlusion (RVO), lung issues such as interstitial lung disease or pneumonitis, and allergic reactions to its components including dimethyl sulfoxide.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a specific BRAF mutation not V600, or a BRAF fusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed at baseline, then every 2 cycles until disease progression, up to 3 years post registration
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed at baseline, then every 2 cycles 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
Overall Response Rate (ORR)
Secondary outcome measures
6-month Progression-free Survival (PFS) Rate
Progression-free Survival
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 of each cycle. 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
13,657 Previous Clinical Trials
40,933,632 Total Patients Enrolled
Douglas B JohnsonPrincipal InvestigatorECOG-ACRIN Cancer Research Group
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not allergic to trametinib, similar drugs, or DMSO.I have not taken any MEK inhibitor medications.I don't have, nor am I at risk for, a blocked vein in my eye.My cancer has a specific BRAF mutation not V600, or a BRAF fusion.My heart is healthy based on recent tests, and I haven't had certain antibody therapies in the last 8 weeks.I have never had interstitial lung disease or pneumonitis.
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.
Has the FDA approved Trametinib Dimethyl Sulfoxide for therapeutic use?
"The safety rating of Trametinib Dimethyl Sulfoxide was determined to be a 2 on the Power scale, due to its status as a Phase 2 trial. This implies that while limited data is available regarding efficacy, there are some studies affirming its security."
Answered by AI
How many participants has this trial recruited so far?
"Currently, this trial is not taking on new patients. It was initially posted in August 2015 and last edited in September 2022. For individuals seeking alternative studies, there are 4,664 clinical trials actively looking for participants with refractory lymphomas and 92 studies using Trametinib Dimethyl Sulfoxide recruiting volunteers."
Answered by AI
Does the scientific literature include any other research regarding Trametinib Dimethyl Sulfoxide?
"At the moment, 6 of 92 Trametinib Dimethyl Sulfoxide clinical trials are in their last stage. A sizable portion of those can be found in Philadelphia though there are 5794 sites around the world that host research on this drug."
Answered by AI
Are there any opportunities for participants to join this research initiative?
"Clinicaltrials.gov records indicate that this study, which was initially listed on August 12th 2015, is no longer recruiting participants. However, there are presently 4756 clinical trials actively searching for volunteers."
Answered by AI
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