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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
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
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterOTHER
2,987 Previous Clinical Trials
1,797,993 Total Patients Enrolled
15 Trials studying Neuroendocrine Tumors
1,289 Patients Enrolled for Neuroendocrine Tumors
NovartisIndustry Sponsor
1,614 Previous Clinical Trials
2,721,373 Total Patients Enrolled
20 Trials studying Neuroendocrine Tumors
972 Patients Enrolled for Neuroendocrine Tumors
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,890 Total Patients Enrolled
12 Trials studying Neuroendocrine Tumors
450 Patients Enrolled for Neuroendocrine Tumors
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: LEE011 and everolimus
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.
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