← Back to Search

mTOR Inhibitor

Trametinib + Everolimus for Recurrent Brain Cancer

Phase 1
Recruiting
Led By Sabine Mueller
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Creatinine clearance or radioisotope growth factor receptor (rGFR) >= 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows: 1 to < 2 years: 0.6 (male), 0.6 (female); 2 to < 6 years: 0.8 (male), 0.8 (female); 6 to < 10 years: 1 (male), 1 (female); 10 to < 13 years: 1.2 (male), 1.2 (female); 13 to < 16 years: 1.5 (male), 1.4 (female); >= 16 years: 1.7 (male), 1.4 (female)
Participants must have histologically confirmed diagnosis of an LGG (WHO grade I-II) that is recurrent or progressive after prior treatment (biologic, chemotherapy or radiation therapy) or must have a histologically confirmed diagnosis of a high grade glioma (HGG) (WHO grade III-VI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial studies the side effects and best dose of two drugs, trametinib and everolimus, in treating pediatric and young adult patients with low grade gliomas that has come back (recurrent).

Who is the study for?
This trial is for pediatric and young adult patients with recurrent gliomas, including those with low grade (WHO I-II) or high grade (III-VI) tumors. It's open to participants who've had prior treatments and have stable neurological deficits. They must not be pregnant, agree to use contraception, and meet specific health criteria like adequate blood counts and organ function.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Trametinib targets a protein called MEK to stop tumor growth, while Everolimus blocks a different pathway that helps tumors grow. The goal is to see if using both drugs together is more effective than using them separately in treating gliomas.See study design
What are the potential side effects?
Potential side effects include skin rash, diarrhea, fatigue, mouth sores, infections due to weakened immune system, liver problems indicated by yellowing of the skin or eyes (jaundice), shortness of breath from lung issues, abnormal blood tests reflecting kidney or pancreas problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My kidney function is within the required range for my age and gender.
Select...
My brain tumor is low-grade and has returned or worsened after treatment, or it is high-grade.
Select...
My cancer started in the spinal cord or has spread widely.
Select...
I am over 18 and my blood pressure is below 140/90 mm Hg.
Select...
It's been over 6 months since my allogeneic bone marrow transplant or over 3 months since my autologous transplant.
Select...
My cancer can be measured or observed.
Select...
My child's blood pressure is within the normal range for their age, height, and gender.
Select...
I had my last radiation treatment more than 12 weeks ago and my cancer has progressed since then.
Select...
I can provide tissue samples or previous test results for genomic testing.
Select...
I received my last monoclonal antibody treatment over four weeks ago.
Select...
My bilirubin levels are within the normal range for my age.
Select...
I have had treatments other than just surgery for my low-grade glioma.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Curve (AUC) of trametinib and everolimus
Dose limiting toxicities (DLTs) of the combination for both continuous and intermittent dosing schedules
Incidence of adverse events for both continuous and intermittent dosing schedules
+3 more

Side effects data

From 2021 Phase 2 trial • 206 Patients • NCT02034110
58%
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%
Dermatitis acneiform
9%
Oedema peripheral
9%
Hypokalaemia
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%
Skin lesion
5%
Erythema nodosum
5%
Hypophosphataemia
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%
Hypersensitivity
2%
Upper respiratory tract infection
2%
Hot flush
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)
Low Grade (WHO G1/G2) Glioma (LGG) (Post-treatment Survival Follow-up)
Hairy Cell Leukemia (HCL) (On-Treatment)
High Grade (WHO G3/G4) Glioma (HGG) (Post-treatment Survival Follow-up)
Low Grade (WHO G1/G2) Glioma (LGG) (On-Treatment)
Hairy Cell Leukemia (HCL) (Post-treatment Survival Follow-up)
Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)
Gastrointestinal Stromal Tumor (GIST) (On-Treatment)
Gastrointestinal Stromal Tumor (GIST) (Post-treatment Survival Follow-up)
High Grade (WHO G3/G4) Glioma (HGG) (On-Treatment)
Multiple Myeloma (MM) (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, everolimus)Experimental Treatment2 Interventions
Patients receive dosing per their assigned dose level. Treatment repeats every 28 days for up to 26 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
Everolimus
2010
Completed Phase 4
~1510

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,521 Previous Clinical Trials
15,242,164 Total Patients Enrolled
Novartis PharmaceuticalsIndustry Sponsor
2,868 Previous Clinical Trials
4,199,826 Total Patients Enrolled
Pediatric Brain Tumor FoundationUNKNOWN
1 Previous Clinical Trials
30 Total Patients Enrolled

Media Library

Everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04485559 — Phase 1
Brain Tumor Research Study Groups: Treatment (trametinib, everolimus)
Brain Tumor Clinical Trial 2023: Everolimus Highlights & Side Effects. Trial Name: NCT04485559 — Phase 1
Everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04485559 — Phase 1
~25 spots leftby Dec 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top