What side effects are associated with this type of intervention?

Common treatments for cancer, particularly those involving MEK inhibitors like Trametinib, often have side effects such as diarrhea, dermatitis acneiform, maculopapular rash, fatigue, dry skin, nausea, dyspnea, and vomiting. These side effects are consistent with other targeted therapies that inhibit specific proteins involved in cancer cell growth. Managing these side effects is crucial to maintaining the patient's quality of life during treatment.

What prior FDA approvals exist?

Trametinib, a MEK1 and MEK2 inhibitor, has been approved by the FDA for the treatment of cancers with BRAF mutations, particularly in combination with the BRAF inhibitor dabrafenib for BRAF V600E-mutated tumors. This combination has shown efficacy in various cancers, including melanoma. Other related drugs include selumetinib, another MEK inhibitor, approved for neurofibromatosis type 1 (NF1) with symptomatic, inoperable plexiform neurofibromas. These approvals highlight the role of targeted therapies in managing cancers with specific genetic mutations.

What other types of research exist?

Promising novel alternatives to Trametinib for cancer treatment in 2024 include: 1) PI3K/PTEN/AKT/mTOR pathway inhibitors such as Temsirolimus and Everolimus, which have shown potential in endometrial cancer and other malignancies. 2) Immune checkpoint inhibitors like anti-PD-1 and anti-CTLA-4 therapies, which have demonstrated efficacy in various cancers including lung and head and neck cancers. 3) RET inhibitors such as Selpercatinib and Pralsetinib for RET-mutated tumors, particularly in thyroid cancer. 4) Farnesyltransferase inhibitors like Tipifarnib for HRAS mutant squamous cell carcinoma of the head and neck. These agents represent promising alternatives due to their targeted mechanisms and clinical trial results.

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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

Must not have

Patients must not have known hypersensitivity to trametinib or compounds of similar chemical or biologic composition or to dimethyl sulfoxide (DMSO)

Patients who previously received MEK inhibitors (including, but not limited to, trametinib, binimetinib, cobimetinib, selumetinib, RO4987655 (CH4987655), GDC-0623 and pimasertib) will be excluded

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

No Placebo-Only Group

Summary

This trial tests trametinib, an oral medication taken regularly, in patients with advanced cancers having BRAF mutations. Trametinib works by blocking proteins that help cancer cells grow. Researchers aim to see if it can shrink these cancers or stop their growth.

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.

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.

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 below

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My cancer has a specific BRAF mutation not V600, or a BRAF fusion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not allergic to trametinib, similar drugs, or DMSO.

Select...

I have not taken any MEK inhibitor medications.

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I don't have, nor am I at risk for, a blocked vein in my eye.

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I have never had interstitial lung disease or pneumonitis.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at baseline, then every 2 cycles until disease progression, up to 3 years post registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR)

Secondary study objectives

6-month Progression-free Survival (PFS) Rate

Progression-free Survival

Side effects data

From 2018 Phase 2 trial • 9 Patients • NCT02281760

100%

Chills

100%

Rash

100%

Hyperthermia

100%

Anaemia

83%

Dehydration

67%

Blood urea increased

67%

Fatigue

67%

Headache

67%

Lipase increased

50%

Back pain

50%

Nausea

50%

Diarrhoea

50%

Amylase increased

50%

Blood creatine phosphokinase increased

50%

Hyponatraemia

50%

Blood cholesterol increased

50%

Pain in extremity

50%

Blood creatinine increased

33%

Red blood cells urine

33%

Hypertriglyceridaemia

33%

Alanine aminotransferase increased

33%

Blood alkaline phosphatase increased

33%

Blood pressure increased

33%

Hypertension

33%

Disturbance in attention

33%

Labile hypertension

33%

Vomiting

33%

Dyspepsia

33%

Urinary tract infection

33%

Aspartate aminotransferase increased

33%

Myalgia

33%

Cough

33%

Hypotension

33%

Ataxia

33%

Malaise

33%

Abdominal pain

17%

Hypomagnesaemia

17%

Arthritis

17%

Viral infection

17%

Hypernatraemia

17%

Anorexia nervosa

17%

Nasal congestion

17%

Gamma-glutamyltransferase increased

17%

Pharyngitis

17%

Sweating fever

17%

Erythema nodosum

17%

Gingival recession

17%

Confusional state

17%

Cystatin C increased

17%

Syncope

17%

Lip dry

17%

Blood thyroid stimulating hormone decreased

17%

Prothrombin time prolonged

17%

Hyperuricaemia

17%

Arthralgia

17%

Joint effusion

17%

Memory impairment

17%

Acute kidney injury

17%

Proteinuria

17%

Penile pain

17%

Urosepsis

17%

Hyperglycaemia

17%

Dyspnoea

17%

Lymphadenopathy

17%

Skin sensitisation

17%

Paronychia

17%

Leukopenia

17%

Vertigo

100%

80%

60%

40%

20%

Study treatment Arm

Combination Therapy With Dabrafenib and Trametinib in Patients With ECD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Targeted cancer therapies, such as Trametinib, work by inhibiting specific molecules involved in cancer cell growth and survival. Trametinib targets MEK1 and MEK2, key proteins in the MAPK/ERK pathway, which is often dysregulated in cancers. By blocking this pathway, Trametinib can prevent cancer cell proliferation and induce apoptosis. This targeted approach is significant for cancer patients as it offers a more personalized treatment, potentially improving efficacy and reducing side effects compared to traditional chemotherapy.

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