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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
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
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
I have mild liver issues with specific bilirubin and AST levels.
Timeline
Screening ~ 3 weeks3 visits
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
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Dose-limiting toxicity
Maximum tolerated dose of trametinib
Pharmacokinetic profile of trametinib
Secondary outcome measures
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 • NCT0203411058%
Pyrexia
42%
Nausea
35%
Vomiting
33%
Diarrhoea
33%
Fatigue
28%
Gamma-glutamyltransferase increased
28%
Chills
28%
Rash
26%
Aspartate aminotransferase increased
23%
White blood cell count decreased
23%
Cough
23%
Anaemia
23%
Decreased appetite
23%
Headache
21%
Constipation
21%
Blood alkaline phosphatase increased
19%
Dry mouth
19%
Hyperglycaemia
19%
Myalgia
16%
Alanine aminotransferase increased
16%
Asthenia
16%
Abdominal pain upper
16%
Thrombocytopenia
16%
Dyspnoea
14%
Hypertension
14%
Arthralgia
14%
Insomnia
12%
Platelet count decreased
12%
Eczema
12%
Blood creatinine increased
12%
Pruritus
12%
Abdominal pain
12%
Hypomagnesaemia
12%
Hyponatraemia
12%
Erythema
9%
Oedema peripheral
9%
Hypokalaemia
9%
Dermatitis acneiform
9%
Rash maculo-papular
9%
Neutrophil count decreased
9%
Weight increased
9%
Back pain
9%
Dry skin
7%
Blood bilirubin increased
7%
Sepsis
7%
Neutropenia
7%
Mucosal inflammation
7%
Oedema
7%
Cholangitis
7%
Hypoalbuminaemia
7%
Stomatitis
7%
Dyspepsia
7%
Influenza like illness
7%
Herpes zoster
7%
Glycosylated haemoglobin increased
7%
Weight decreased
7%
Musculoskeletal pain
7%
Pain in extremity
7%
Anxiety
7%
Acute kidney injury
7%
Night sweats
5%
Hypophosphataemia
5%
Skin lesion
5%
Erythema nodosum
5%
Dry eye
5%
Toothache
5%
Muscle spasms
5%
Blood creatine phosphokinase increased
5%
Hyperuricaemia
5%
Gastrooesophageal reflux disease
5%
Leukopenia
5%
Folliculitis
5%
Urinary tract infection
5%
Fall
5%
Lymphocyte count decreased
5%
Hypoglycaemia
5%
Joint swelling
5%
Neuropathy peripheral
5%
Epistaxis
5%
Oropharyngeal pain
5%
Acne
5%
Hyperkeratosis
2%
Hot flush
2%
Femoral neck fracture
2%
Hypersensitivity
2%
Upper respiratory tract infection
2%
Productive cough
2%
Pain in jaw
2%
Epilepsy
2%
Peripheral sensory neuropathy
2%
Depression
2%
Hypercalcaemia
2%
Dizziness
2%
Skin mass
2%
Pneumonia
2%
Thrombophlebitis
2%
Tachycardia
2%
Musculoskeletal chest pain
2%
Dysgeusia
2%
Sciatica
2%
Gastroenteritis
2%
Febrile neutropenia
2%
Atrial fibrillation
2%
Oral pain
2%
Rectal haemorrhage
2%
Paronychia
2%
Device related infection
2%
Rhinitis
2%
Sinusitis
2%
Respiratory tract infection
2%
Hyperkalaemia
2%
Transaminases increased
2%
Dehydration
2%
Spinal pain
2%
Haemorrhoids
2%
Cataract
2%
Eye pain
2%
Vision blurred
2%
Visual impairment
2%
Abdominal discomfort
2%
Abdominal distension
2%
Gait disturbance
2%
Non-cardiac chest pain
2%
Xerosis
2%
Conjunctivitis
2%
Nasopharyngitis
2%
Rash pustular
2%
Tooth abscess
2%
Tooth infection
2%
Procedural pain
2%
Blood lactate dehydrogenase increased
2%
Blood uric acid increased
2%
C-reactive protein increased
2%
Muscular weakness
2%
Neck pain
2%
Basal cell carcinoma
2%
Seborrhoeic keratosis
2%
Paraesthesia
2%
Proteinuria
2%
Renal failure
2%
Nasal congestion
2%
Pleural effusion
2%
Nail discolouration
2%
Palmar-plantar erythrodysaesthesia syndrome
2%
Photosensitivity reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Biliary Tract Cancer (BTC) (On-Treatment)
Hairy Cell Leukemia (HCL) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Multiple Myeloma (MM) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
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)
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
~1550
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,654 Previous Clinical Trials
40,933,107 Total Patients Enrolled
104 Trials studying Liver Cancer
26,668 Patients Enrolled for Liver Cancer
Lillian L SiuPrincipal InvestigatorUniversity Health Network Princess Margaret Cancer Center LAO
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this experiment recruiting participants at the current time?
"This trial is no longer recruiting for participants; the initial posting was on February 12th 2014, and it has not been updated since August 12th 2022. If you are searching for other studies, there are 2397 clinical trials currently enrolling patients with liver diseases and 92 trials involving Trametinib actively seeking participants."
Answered by AI
How many participants have thus far joined this experiment?
"This trial has concluded its recruitment phase and is currently not seeking new candidates. The study was initially posted on February 12, 2014 and the last edit happened on August 12, 2022. For those looking for other clinical trials with liver related focus, 2397 studies are actively recruiting while 92 of them involve Trametinib drugs specifically."
Answered by AI
Is Trametinib a viable solution for safe patient care?
"There is only modest clinical data that supports the efficacy and security of trametinib, resulting in a score of 1."
Answered by AI
Are there any precedent examinations involving Trametinib?
"Currently, there are 92 clinical trials that involve Trametinib. 6 of those investigations have advanced to Phase 3 and they're primarily located in the Saint Louis area. In total, 5794 trial sites worldwide are studying this medicine."
Answered by AI
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