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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

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My kidney function is within the required range for my age and gender.

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My brain tumor is low-grade and has returned or worsened after treatment, or it is high-grade.

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My cancer started in the spinal cord or has spread widely.

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I am over 18 and my blood pressure is below 140/90 mm Hg.

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It's been over 6 months since my allogeneic bone marrow transplant or over 3 months since my autologous transplant.

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My cancer can be measured or observed.

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My child's blood pressure is within the normal range for their age, height, and gender.

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I had my last radiation treatment more than 12 weeks ago and my cancer has progressed since then.

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I can provide tissue samples or previous test results for genomic testing.

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I received my last monoclonal antibody treatment over four weeks ago.

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My bilirubin levels are within the normal range for my age.

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I have had treatments other than just surgery for my low-grade glioma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

50%

Nausea

40%

Neutropenia

30%

Diarrhoea

30%

Decreased appetite

30%

Thrombocytopenia

30%

Vomiting

30%

Anaemia

30%

Constipation

30%

Fatigue

30%

Pyrexia

30%

Rash

20%

Infection

20%

Alopecia

20%

Hypokalaemia

20%

Chills

20%

Urinary tract infection

20%

Blood alkaline phosphatase increased

20%

Spinal pain

20%

Mucosal inflammation

20%

Oedema peripheral

20%

Arthralgia

10%

Hypocalcaemia

10%

Confusional state

10%

Microcytic anaemia

10%

Dry eye

10%

Abdominal distension

10%

Dyspnoea

10%

Pain in extremity

10%

Dizziness

10%

Renal failure

10%

Influenza

10%

Cachexia

10%

Abdominal pain

10%

Pain

10%

Oropharyngeal candidiasis

10%

Radiation associated pain

10%

Hypoaesthesia

10%

Retinal detachment

10%

Cough

10%

Small intestinal obstruction

10%

Enterobacter infection

10%

Xeroderma

10%

Urinary tract infection bacterial

10%

Gastrooesophageal reflux disease

10%

Dry mouth

10%

Asthenia

10%

Gait disturbance

10%

Folliculitis

10%

Gastroenteritis

10%

Nasopharyngitis

10%

Rhinitis

10%

Sinusitis

10%

Streptococcal infection

10%

Blood creatinine increased

10%

Blood lactate dehydrogenase increased

10%

C-reactive protein increased

10%

Ejection fraction decreased

10%

Electrocardiogram QT prolonged

10%

Liver function test increased

10%

Weight decreased

10%

Back pain

10%

Bone pain

10%

Flank pain

10%

Muscular weakness

10%

Myalgia

10%

Synovial cyst

10%

Paraesthesia

10%

Depressed mood

10%

Insomnia

10%

Benign prostatic hyperplasia

10%

Lung disorder

10%

Skin mass

10%

Hypertension

100%

80%

60%

40%

20%

Study treatment Arm

Multiple Myeloma (MM) (On-Treatment)

Adenocarcinoma of the Small Intestine (ASI) (Post-treatment Survival Follow-up)

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)

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, 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

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,505 Previous Clinical Trials

15,237,505 Total Patients Enrolled

Novartis PharmaceuticalsIndustry Sponsor

2,856 Previous Clinical Trials

4,197,655 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential dangers do individuals face when using Trametinib?

"Trametinib's safety is rated as a 1 since this trial falls under Phase 1, indicating that only minimal evidence exists to support its effectiveness and security."

Answered by AI

Are there any eligibility requirements I must meet to be accepted into this clinical trial?

"This medical trial is recruiting 50 individuals with glioma between one year old and 25 years. The criteria to join the study necessitate that participants must have a histologically confirmed diagnosis of LGG (WHO grade I-II) or HGG (WHO Grade III-VI). Moreover, patients need to have received prior therapy other than surgery, such as chemotherapy, biologics, immunotherapy or radiotherapy before enrolling in this research project. Also required are snap frozen tissue samples for comprehensive genomic testing or results from similar tests previously conducted. Additionally those who had taken myelosuppressive anticancer drugs should've ceased their intake three"

Answered by AI

How many individuals are partaking in this research endeavor?

"This clinical research is in search of 50 eligible patients, who are able to adhere to the inclusion criteria. Those interested may take part from medical centers such as University of Florida in Gainesville and Riley Hospital for Children in Indianapolis."

Answered by AI

Does this research endeavor cater to individuals aged 85 and over?

"This medical trial mandates that participants must be between a year old and 25 years of age. 285 studies are available for minors while 1,270 can provide assistance to elderly individuals."

Answered by AI

What pathologies is Trametinib commonly administered to address?

"Trametinib is a medication capable of treating unresectable melanoma, liver transplant rejection and renal allotransplant rejections."

Answered by AI

Is this research being conducted in numerous hospitals across the North American region?

"The study is currently enrolling patients at University of Florida (Gainesville, FL), Riley Hospital for Children (Indianapolis, IN) and University of California San Francisco (San Francisco, CA). Additionally, there are 14 other medical centres included in the trial."

Answered by AI

Are recruits welcome to join this experiment?

"Clinicaltrials.gov confirms that this medical research is still recruiting patients, having been first posted on December 9th 2020 and updated most recently on October 28th 2022."

Answered by AI

Could you please summarize any prior research related to Trametinib?

"Trametinib was initially studied at Sheba Medical Center in 2008. Since then, 472 trials have been completed with 180 more actively recruiting clinical participants. The majority of these new studies are conducted out of Gainesville, Florida."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)

Sabine Mueller, MD, PhD 2020. "Trametinib and Everolimus for Treatment of Pediatric and Young Adult Patients With Recurrent Gliomas (PNOC021)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04485559.

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