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MEK Inhibitor
Trametinib for Epithelioid Hemangioendothelioma
Phase 2
Waitlist Available
Led By Scott M Schuetze
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the time of first dose of study drug to occurrence of death from any cause, assessed at 2 years
Awards & highlights
Study Summary
This trial studies how well trametinib works in treating patients with metastatic, locally advanced, or unresectable epithelioid hemangioendothelioma.
Eligible Conditions
- Epithelioid Hemangioendothelioma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the time of first dose of study drug to occurrence of death from any cause, assessed at 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the time of first dose of study drug to occurrence of death from any cause, assessed at 2 years
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
Secondary outcome measures
Change in patient reported symptoms
Incidence of adverse events
Median progression-free survival
+2 moreOther outcome measures
Change in CRP level
Change in ESR level
Change in epithelioid hemangioendothelioma growth rate
+5 moreSide 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%
Rash maculo-papular
9%
Oedema peripheral
9%
Hypokalaemia
9%
Dermatitis acneiform
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%
Femoral neck fracture
2%
Productive cough
2%
Hot flush
2%
Hypersensitivity
2%
Upper respiratory tract infection
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)
Anaplastic Thyroid Cancer (ATC) (Post-treatment Survival Follow-up)
Anaplastic Thyroid Cancer (ATC) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (On-Treatment)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Multiple Myeloma (MM) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (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)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (trametinib)Experimental Treatment2 Interventions
Patients receive trametinib PO QD on days 1-28. Treatment repeats every 28 days for up to 52 cycles 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
13,687 Previous Clinical Trials
40,930,327 Total Patients Enrolled
Scott M SchuetzePrincipal InvestigatorUniversity of Michigan Comprehensive Cancer Center EDDOP
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had another type of cancer in the past.You have a device called an intra-cardiac defibrillator implanted in your heart.You cannot take any herbal supplements during the study, including popular ones like St. John's wort, ginkgo biloba, or ginseng.You have a history of or are currently at risk for a vision problem called retinal vein occlusion (RVO).Your cancer has either gotten worse according to a specific measurement method, or you are experiencing significant pain that needs to be managed with strong pain medications.You are expected to live for at least 6 more months.You have cancer that has spread to your brain or spinal cord and is causing symptoms.You cannot be receiving any other cancer treatments while participating in this study, except for megestrol (Megace) if it is being used to increase your appetite.You have a history of serious heart rhythm problems that are not currently under control, except if you have had atrial fibrillation for more than 30 days and it is being managed well.You have experienced a heart attack, unstable angina, had a coronary angioplasty or stenting within the last 6 months.You have cancer that has spread to your heart.You have already received treatment with a medication called a MEK inhibitor before.You can participate in the study whether you have been treated for epithelioid hemangioendothelioma (EHE) before or not. The number of previous treatments you have had does not matter.You have had a lung disease in the past that required extra oxygen or treatment with strong medications.You have experienced allergic reactions or adverse effects to medications similar to trametinib or to the substances used to make it.You have a history or signs of heart problems, such as issues with your heart or blood vessels.You have high blood pressure that cannot be controlled with medication.
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.
Can you provide information on any prior trials that have utilized Trametinib?
"Trametinib was initial trialed at the University of Chicago Medical Centre in 2012, and since then 247 studies have been completed. Currently, 92 trials are actively recruiting participants; with a large concentration of these occurring within Omaha, Nebraska."
Answered by AI
Might Trametinib pose a risk to human health?
"Trametinib's safety has been partially supported by data in Phase 2 trials, giving it a score of 2 on our internal scale. However, there is currently no evidence supporting its efficacy."
Answered by AI
How many healthcare facilities have implemented this research experiment?
"Within the United States, patients are being recruited for this trial at 36 distinct sites. This includes University of Nebraska Medical Center in Omaha, University of Kansas Clinical Research Center in Fairway, and Montefiore Medical Center - Moses Campus in Bronx among other locations."
Answered by AI
How many participants have enrolled in this clinical investigation?
"This trial is no longer open for recruitment. According to the timeline posted on clinicaltrials.gov, it was first listed in April 19th 2017 and last updated on October 19th 2022. At present time, there are 12 trials searching for patients with hemangioendothelioma and 92 studies utilizing Trametinib actively recruiting around the world."
Answered by AI
Is this research actively seeking new participants?
"Unfortunately, according to clinicaltrials.gov records, this medical study is not currently seeking participants; the post was initially published on April 19th 2017 and last updated on October 19th 2022. However, there are presently 104 other trials that require enrolment of volunteers."
Answered by AI
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