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MEK Inhibitor

Trametinib for Cancer

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 an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have NONE of the following cardiac criteria: Clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block), Treatment-refractory hypertension defined as a blood pressure of systolic > 140 mmHg and/or diastolic > 90 mmHg which cannot be controlled by anti-hypertensive therapy
Patients with glioblastoma must have histologically or radiographically confirmed recurrent or progressive World Health Organization (WHO) grade 4 glioma (glioblastoma). NOTE: All baseline and post-baseline disease assessments must be performed using contrast-enhanced cranial magnetic resonance imaging (MRI) or contrast-enhanced computed tomography (CT) for subjects who cannot have MRI performed
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 whether trametinib can shrink or stop the growth of cancer with GNAQ or GNA11 mutations.

Who is the study for?
This trial is for patients with various cancers, including solid tumors and blood cancers like lymphoma and multiple myeloma, who have specific genetic changes (GNAQ or GNA11 mutations). They must have met previous MATCH Protocol criteria, have a stable heart condition verified by ECG and echocardiogram/MUGA scan, and not be hypertensive. Those with glioblastoma need confirmed recurrence. People with uveal melanoma, prior MEK inhibitor treatment, lung disease/pneumonitis history, trametinib/DMSO hypersensitivity or risk of retinal vein occlusion are excluded.Check my eligibility
What is being tested?
The trial tests Trametinib Dimethyl Sulfoxide on patients whose cancer has GNAQ/GNA11 mutations. Trametinib aims to inhibit MEK1/MEK2 proteins that may promote the growth of these genetically mutated cancer cells. The goal is to see if this targeted therapy can shrink the tumors or halt their progression.See study design
What are the potential side effects?
Trametinib may cause side effects such as skin rash, diarrhea, fatigue and possibly affect vision due to its action on certain cellular pathways in the body. It might also lead to heart-related issues since it requires cardiac health monitoring before administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent ECG showed no major heart issues and my blood pressure is under control.
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I have a confirmed case of grade 4 glioblastoma that is getting worse.
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My heart's pumping ability is normal based on a recent heart scan.
Select...
My cancer has GNAQ or GNA11 mutations.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

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 • NCT02281760
100%
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
40,933,149 Total Patients Enrolled
Jason J LukePrincipal InvestigatorECOG-ACRIN Cancer Research Group
3 Previous Clinical Trials
106 Total Patients Enrolled

Media Library

Trametinib (MEK Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04439357 — Phase 2
Cancer Research Study Groups: Treatment (trametinib)
Cancer Clinical Trial 2023: Trametinib Highlights & Side Effects. Trial Name: NCT04439357 — Phase 2
Trametinib (MEK Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439357 — Phase 2

Frequently Asked Questions

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

Has prior research been conducted involving Trametinib Dimethyl Sulfoxide?

"Presently, 92 clinical trials centred around Trametinib Dimethyl Sulfoxide are in progress. Of these studies, 6 have progressed to the third stage of research. With the centre of operations being located in Saint Louis, Missouri, there is a total 5794 sites hosting experiments with this medication."

Answered by AI

Could new participants still be accepted into this research endeavor?

"As per the information on clinicaltrials.gov, this study is no longer enrolling participants; it was initially listed in February 25th 2016 and last modified on July 27th 2022. Nevertheless, there are still 4761 other medical trials actively recruiting patients at present."

Answered by AI

What potential risks do patients face when taking Trametinib Dimethyl Sulfoxide?

"The safety of Trametinib Dimethyl Sulfoxide is estimated to be a 2 as the trial it is currently in does not yet have any data supporting efficacy. However, there are multiple rounds of testing that suggest this medication is safe for use."

Answered by AI

What is the current participant count for this clinical research?

"At the present moment, this trial is not recruiting patients. Initially posted in February of 2016 and last updated on July 27th 2022, recruitment for this particular experiment has been paused. For those looking to participate in other studies, there are currently 4669 malignant neoplasm trials open as well as 92 Trametinib Dimethyl Sulfoxide clinical investigations accepting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Testing Trametinib as a Potential Targeted Treatment in Cancers With GNAQ or GNA11 Genetic Changes (MATCH-Subprotocol S2)
2016. "Testing Trametinib as a Potential Targeted Treatment in Cancers With GNAQ or GNA11 Genetic Changes (MATCH-Subprotocol S2)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439357.
~0 spots leftby Apr 2025
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