Trametinib for Hemangioendothelioma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Hemangioendothelioma+4 More
Trametinib - Drug
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies how well trametinib works in treating patients with metastatic, locally advanced, or unresectable epithelioid hemangioendothelioma.

Eligible Conditions
  • Hemangioendothelioma
  • Epithelioid hemangioendothelioma
  • Unresectable Epithelioid Hemangioendothelioma
  • Metastatic Epithelioid Hemangioendothelioma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Hemangioendothelioma

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: From the time of first dose of study drug to occurrence of death from any cause, assessed at 2 years

Month 6
Change in CRP level
Change in ESR level
Change in epithelioid hemangioendothelioma growth rate
Change in patient reported symptoms
Change in plasma CTGF level
Change in tumor volume
Year 2
Overall survival
Month 6
Progression-free survival
Month 6
Median progression-free survival
Up to 6 months
Incidence of adverse events
MAP kinase activation
Number of TAZ-CAMTA1 gene fusion
Objective response rate
Percent of TAZ-CAMTA1 gene fusion

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Hemangioendothelioma

Side Effects for

Cohort D
47%Pyrexia
47%Headache
41%Diarrhoea
35%Constipation
35%Myalgia
35%Nausea
35%Vomiting
35%Chills
35%Arthralgia
29%Abdominal pain
29%Asthenia
24%Folliculitis
24%Gamma-glutamyltransferase increased
18%Blood alkaline phosphatase increased
18%Weight decreased
18%Decreased appetite
18%Aphasia
18%Rash
18%Oedema peripheral
18%Dry mouth
18%Fatigue
18%Aspartate aminotransferase increased
18%Alanine aminotransferase increased
18%Muscular weakness
18%Dizziness
18%Seizure
18%Cough
18%Dry skin
12%Insomnia
12%Hypophosphataemia
12%Epistaxis
12%Eyelid oedema
12%Ejection fraction decreased
12%Anaemia
12%Thrombocytopenia
12%Visual impairment
12%Urinary tract infection
12%Weight increased
12%Hypocalcaemia
12%Hypokalaemia
12%Back pain
12%Pain in extremity
12%Paraesthesia
12%Partial seizures
12%Alopecia
12%Pruritus
6%Blood cholesterol increased
6%Blood sodium increased
6%Bronchitis
6%Anxiety
6%Skin striae
6%Gastrointestinal haemorrhage
6%Neck pain
6%Abdominal pain upper
6%Acute kidney injury
6%Conjunctival irritation
6%Eye pruritus
6%Diplopia
6%Vision blurred
6%Vitreous detachment
6%Gastrooesophageal reflux disease
6%Pain
6%Xerosis
6%Cellulitis
6%Respiratory tract infection
6%Skin infection
6%Blood potassium decreased
6%Lipase increased
6%Neutrophil count decreased
6%Dehydration
6%Muscle spasms
6%Musculoskeletal pain
6%Musculoskeletal chest pain
6%Tendonitis
6%Papilloma
6%Motor dysfunction
6%Paresis
6%Visual field defect
6%Sleep disorder
6%Metrorrhagia
6%Nasal congestion
6%Rhinitis allergic
6%Dermatitis acneiform
6%Erythema
6%Generalised erythema
6%Skin exfoliation
6%Hot flush
6%Hypotension
6%Lymphoedema
6%Onychomycosis
6%Papule
6%Renal failure
6%Dry eye
6%Punctate keratitis
6%Visual acuity reduced
6%Abdominal pain lower
6%Faeces soft
6%Gastrointestinal disorder
6%Face oedema
6%Lung infection
6%Herpes zoster
6%Rash pustular
6%Hyperhidrosis
6%Ligament sprain
6%Amylase increased
6%Blood creatinine increased
6%Hypomagnesaemia
6%Hyponatraemia
6%Joint range of motion decreased
6%Intertrigo
6%Night sweats
6%Amnesia
6%Dysarthria
6%Pain of skin
6%Tonic clonic movements
6%Agitation
6%Confusional state
6%Dyspnoea
6%Productive cough
6%Aquagenic wrinkling of palms
6%Pruritus generalised
6%Skin lesion
6%Deep vein thrombosis
6%Presyncope
6%Temporal lobe epilepsy
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT02039947) in the Cohort D ARM group. Side effects include: Pyrexia with 47%, Headache with 47%, Diarrhoea with 41%, Constipation with 35%, Myalgia with 35%.

Trial Design

1 Treatment Group

Treatment (trametinib)
1 of 1
Experimental Treatment

27 Total Participants · 1 Treatment Group

Primary Treatment: Trametinib · No Placebo Group · Phase 2

Treatment (trametinib)Experimental Group · 2 Interventions: Trametinib, Questionnaire Administration · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trametinib
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from the time of first dose of study drug to occurrence of death from any cause, assessed at 2 years

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
12,990 Previous Clinical Trials
41,298,861 Total Patients Enrolled
1 Trials studying Hemangioendothelioma
78 Patients Enrolled for Hemangioendothelioma
Scott M SchuetzePrincipal InvestigatorUniversity of Michigan Comprehensive Cancer Center EDDOP

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are able to swallow 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 small bowel.
You have evidence of disease progression per RECIST 1.1 prior to enrollment or have evidence of cancer-related pain requiring symptom management with narcotic analgesics.
You have an absolute neutrophil count (ANC) of 1 x 10^9/L or more.
You have received prior treatment-related toxicities.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 30th, 2021

Last Reviewed: October 31st, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.