← Back to Search

mTOR Inhibitor

LEE011 + Everolimus for Neuroendocrine Cancer

Phase 2

Waitlist Available

Led By Diane Reidy-Lagunes, MD, MS

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing the combination of LEE011 with everolimus to see if it is effective against cancer with minimal side effects.

Who is the study for?

Adults over 18 with advanced neuroendocrine tumors of foregut origin (like in the lung or stomach) that can't be surgically removed and have a certain level of disease activity. Participants must be relatively healthy, able to take oral medication, not pregnant, willing to use birth control, and have recovered from previous treatments.Check my eligibility

What is being tested?

The trial is testing the effectiveness and safety of combining two drugs: LEE011 and everolimus. These are given to patients who meet specific health criteria to see if this combination works better for treating their cancer compared to current standard treatments.See study design

What are the potential side effects?

Possible side effects include but are not limited to fatigue, nausea, blood count changes, liver function alterations, potential heart issues like irregular heartbeat or QT interval prolongation. Specific reactions depend on individual patient conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 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

Progression Free Survival (PFS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: LEE011 and everolimusExperimental Treatment2 Interventions

Subjects will receive LEE011 200 mg daily, in combination with everolimus 5 mg daily; in the setting of toxicity, everolimus dosing will be changed to 2.5 mg daily or 2.5 mg every other day. Subjects will continue treatment until meeting one of the criteria for removal from study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LEE011

2014

Completed Phase 3

~1960

everolimus

2005

Completed Phase 3

~1550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterOTHER

2,971 Previous Clinical Trials

1,787,216 Total Patients Enrolled

15 Trials studying Neuroendocrine Tumors

1,333 Patients Enrolled for Neuroendocrine Tumors

NovartisIndustry Sponsor

1,611 Previous Clinical Trials

2,721,014 Total Patients Enrolled

19 Trials studying Neuroendocrine Tumors

852 Patients Enrolled for Neuroendocrine Tumors

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,934 Previous Clinical Trials

588,789 Total Patients Enrolled

12 Trials studying Neuroendocrine Tumors

450 Patients Enrolled for Neuroendocrine Tumors

Media Library

everolimus (mTOR Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03070301 — Phase 2

Neuroendocrine Tumors Research Study Groups: LEE011 and everolimus

Neuroendocrine Tumors Clinical Trial 2023: everolimus Highlights & Side Effects. Trial Name: NCT03070301 — Phase 2

everolimus (mTOR Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03070301 — Phase 2

Frequently Asked Questions

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

Are participants being recruited for this trial at the current moment?

"According to the clinicaltrials.gov website, this study is not currently enrolling patients. Although the trial's last update was on February 22nd, 2022, it is one of many trials (316 to be exact) that are actively recruiting participants."

Answered by AI

For what purpose is everolimus most commonly prescribed?

"While most often used to treat renal transplant rejection, everolimus has also proven effective in treating waldenstrom macroglobulinemia, advanced carcinoid tumors, and certain lung conditions."

Answered by AI

What are the possible dangers of taking everolimus?

"Even though there is some data suggesting everolimus is safe, it only received a 2 because there are no studies indicating that it is an effective medication."

Answered by AI

How many individuals are taking part in this experiment?

"Unfortunately, this study is not enrolling patients at the moment. However, if you are looking for other trials, there are currently 170 clinical trials actively enrolling participants with neuroendocrine tumors and 146 studies for everolimus actively admitting participants."

Answered by AI

Do you know of any other research studies that have used everolimus?

"The first clinical trials for everolimus took place in 2008 at Sheba Medical Center. So far, 431 such studies have been completed with 146 more currently underway. Many of these active trials are being conducted in Boston, Massachusetts."

Answered by AI

Recent research and studies

Endocrine-Related CancerJournal

Ribociclib and Everolimus in Well-differentiated Foregut Neuroendocrine Tumors

Raj, Nitya, Youyun Zheng, Haley Hauser, Joanne Chou, Johnathan Rafailov, Jad Bou-Ayache, Peter Sawan, et al.. 2021. “Ribociclib and Everolimus in Well-differentiated Foregut Neuroendocrine Tumors”. Endocrine-related Cancer. Bioscientifica. doi:10.1530/erc-20-0446.

clinicaltrials.govStudy

A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors

2017. "A Study of LEE011 With Everolimus in Patients With Advanced Neuroendocrine Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03070301.