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MEK Inhibitor

Trametinib for Advanced Cancer

Phase 1
Waitlist Available
Led By Lillian L Siu
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
Able to swallow and retain orally-administered medication and does not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
Prior treatment-related toxicities CTCAE grade =< 1 (except alopecia) at enrollment
Must not have
Uncontrolled intercurrent illness
Current use of prohibited medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 0.5, 1, 2, 3, 4, 6, 10, and 24 hours on days 15 and 16 of cycle 1
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a drug called trametinib can help treat patients with advanced cancer that has spread and usually can't be cured or controlled. Trametinib may stop the growth of tumor cells by blocking proteins needed for cell growth. Hepatic dysfunction is common in patients with advanced cancer and usually prevents them from receiving standard treatments or participating in clinical trials. Trametinib may be a better treatment for these patients.

Who is the study for?
This trial is for patients with advanced cancers that can't be cured or controlled, including those with liver dysfunction. It includes people who've failed previous treatments like BRAF inhibitors for melanoma and have solid tumors such as pancreatic cancer. Participants must be able to take oral medication, have a life expectancy over 3 months, and not have had recent other treatments.
What is being tested?
The trial is testing Trametinib's effectiveness and safe dosage in advanced cancer patients with varying levels of liver function. The drug aims to block proteins essential for cancer cell growth which may stop the spread of the disease especially in those typically excluded from trials due to hepatic dysfunction.
What are the potential side effects?
Trametinib may cause side effects such as skin rash, diarrhea, fatigue, nausea and swelling. It might also lead to more serious conditions like heart problems or eye issues (like blurred vision), but these will be closely monitored during the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills and don't have major stomach or bowel issues affecting drug absorption.
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My side effects from previous treatments are mild, except for hair loss.
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My liver is not working well (bilirubin levels are very high).
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My cancer has spread, cannot be surgically removed, and standard treatments have failed.
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My melanoma has the BRAF V600E mutation and did not respond to BRAF inhibitors.
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I finished any previous cancer treatments at least 28 days ago.
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My cancer has spread and cannot be removed by surgery.
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My liver function is moderately impaired.
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I can take care of myself but may not be able to do active work.
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I do not have major stomach or intestine problems.
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My liver issues are not specified by their cause.
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I can swallow and keep down pills.
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I can take care of myself but might not be able to do heavy physical work.
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I have pancreatic cancer.
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My kidney function is normal or near normal.
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My liver function tests are normal.
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I have mild liver issues with specific bilirubin and AST levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any unmanaged ongoing illnesses.
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I am not taking any medications that are not allowed in the study.
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I have or am at risk for retinal vein occlusion.
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I have brain or spinal cord cancer symptoms or untreated cancer spread.
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I have a history of heart problems or am at risk for them.
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My cancer has spread to my heart.
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My high blood pressure does not improve with treatment.
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I haven't had major surgery or intense cancer treatment in the last 28 days.
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I am HIV-positive and on antiretroviral therapy.
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I have had interstitial lung disease or pneumonitis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 0.5, 1, 2, 3, 4, 6, 10, and 24 hours on days 15 and 16 of cycle 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 0.5, 1, 2, 3, 4, 6, 10, and 24 hours on days 15 and 16 of cycle 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-limiting toxicity
Maximum tolerated dose of trametinib
Pharmacokinetic profile of trametinib
Secondary study objectives
Non-dose-limiting toxicities associated with the administration of trametinib
Objective response to treatment
Predictive biomarkers for individual cancer patients

Side effects data

From 2021 Phase 2 trial • 206 Patients • NCT02034110
47%
Pyrexia
36%
Fatigue
33%
Anaemia
33%
Nausea
33%
Decreased appetite
28%
Rash
22%
Headache
22%
Constipation
22%
Pneumonia
22%
Chills
22%
Dyspnoea
19%
Dizziness
19%
Hypoalbuminaemia
19%
Vomiting
19%
Diarrhoea
19%
Hyponatraemia
17%
Dysphagia
17%
Blood alkaline phosphatase increased
17%
Back pain
14%
Aspartate aminotransferase increased
14%
Hypocalcaemia
14%
Dry mouth
14%
Hyperglycaemia
14%
Arthralgia
14%
Oedema peripheral
14%
White blood cell count decreased
14%
Insomnia
14%
Hypotension
11%
Hypokalaemia
11%
Haemoptysis
11%
Alanine aminotransferase increased
11%
Dry skin
11%
Hypothyroidism
11%
Pruritus
11%
Visual impairment
11%
Weight decreased
11%
Cough
8%
Productive cough
8%
Rash maculo-papular
8%
Upper respiratory tract infection
8%
Mucosal inflammation
8%
Hypercalcaemia
8%
Gastrooesophageal reflux disease
8%
Pleural effusion
8%
Night sweats
8%
Asthenia
8%
Ejection fraction decreased
8%
Electrocardiogram QT prolonged
8%
Gamma-glutamyltransferase increased
8%
Neutrophil count decreased
8%
Neck pain
6%
Rhinorrhoea
6%
Haematochezia
6%
Skin lesion
6%
Acute kidney injury
6%
Seborrhoeic keratosis
6%
Pulmonary embolism
6%
Thrombocytopenia
6%
Atrial fibrillation
6%
Stomatitis
6%
Rhinitis allergic
6%
Tachycardia
6%
Abdominal pain upper
6%
Hyperuricaemia
6%
Leukopenia
6%
Sinusitis
6%
Urinary tract infection
6%
Polyneuropathy
6%
Haematuria
6%
Neutropenia
6%
Ear pain
6%
Abdominal pain
6%
Feeling cold
6%
Non-cardiac chest pain
6%
Pain
6%
Fungal infection
6%
Nasopharyngitis
6%
Blood creatinine increased
6%
Blood urea increased
6%
Neutrophil count increased
6%
Hypomagnesaemia
6%
Myalgia
6%
Neuropathy peripheral
6%
Proteinuria
6%
Nasal congestion
6%
Pneumonitis
6%
Palmar-plantar erythrodysaesthesia syndrome
3%
Pelvic infection
3%
Hypophosphataemia
3%
Sepsis
3%
Tinnitus
3%
Malaise
3%
Rhabdomyolysis
3%
Cataract
3%
Dermatitis acneiform
3%
Erythema nodosum
3%
Femoral neck fracture
3%
Aortic thrombosis
3%
Hyperglycaemic hyperosmolar nonketotic syndrome
3%
Pollakiuria
3%
Flushing
3%
Oesophageal stenosis
3%
Atrioventricular block first degree
3%
Photophobia
3%
Dehydration
3%
Toothache
3%
Oral candidiasis
3%
Urinary retention
3%
Alopecia
3%
Skin mass
3%
Aspiration
3%
Vision blurred
3%
Oedema
3%
Depression
3%
Folliculitis
3%
Staphylococcal infection
3%
Clavicle fracture
3%
Aphasia
3%
Cardiac ventricular thrombosis
3%
Stress cardiomyopathy
3%
Oral pain
3%
Clostridium difficile infection
3%
Diverticulitis
3%
Pneumonia aspiration
3%
Pneumonia necrotising
3%
Wound infection
3%
Hyperkalaemia
3%
Rib fracture
3%
Bladder transitional cell carcinoma
3%
Facial nerve disorder
3%
Hypertension
3%
Paralysis recurrent laryngeal nerve
3%
Syncope
3%
Hallucination
3%
Pulmonary haematoma
3%
Sinus bradycardia
3%
Dry eye
3%
Abdominal distension
3%
Dyspepsia
3%
Gait disturbance
3%
Nodule
3%
Xerosis
3%
Conjunctivitis
3%
Tooth infection
3%
Procedural pain
3%
Blood creatine phosphokinase increased
3%
Platelet count decreased
3%
Weight increased
3%
Flank pain
3%
Muscular weakness
3%
Musculoskeletal chest pain
3%
Pain in extremity
3%
Hypoaesthesia
3%
Paraesthesia
3%
Anxiety
3%
Sleep disorder
3%
Dysphonia
3%
Epistaxis
3%
Upper-airway cough syndrome
3%
Wheezing
3%
Erythema
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Biliary Tract Cancer (BTC) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Multiple Myeloma (MM) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (On-Treatment)
Biliary Tract Cancer (BTC) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (Post-treatment Survival Follow-up)

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 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
2014
Completed Phase 2
~1630

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,018,093 Total Patients Enrolled
104 Trials studying Liver Cancer
26,538 Patients Enrolled for Liver Cancer
Lillian L SiuPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
~4 spots leftby Nov 2025
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