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Kinase Inhibitor
Ceritinib + Everolimus for Lung Cancer
Phase 1
Waitlist Available
Led By George R Blumenschein
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For dose escalation cohort: patients with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have failed at least one line of therapy
Able to swallow oral medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 15, and 21 (course 1), day 1 (course 2), day 1 (course 3), and at progression
Awards & highlights
Study Summary
This trial is testing the side effects and best dosage of ceritinib and everolimus for treating patients with solid tumors that have spread from the original site. Ceritinib and everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Who is the study for?
This trial is for adults with advanced solid tumors or stage IIIB-IV non-small cell lung cancer that has spread and who have tried at least one therapy. They must have adequate blood counts, organ function, be able to swallow pills, not be pregnant or breastfeeding, use effective contraception if of childbearing potential, and not have severe medical conditions or a history of certain allergies.Check my eligibility
What is being tested?
The trial is testing the combination of two drugs: Ceritinib and Everolimus. These drugs are thought to block enzymes needed for tumor growth. The study aims to find the best dose with acceptable side effects for patients with locally advanced or metastatic solid tumors or specific stages of lung cancer.See study design
What are the potential side effects?
Potential side effects include fatigue, nausea, diarrhea, changes in blood sugar levels, rash, liver issues like increased enzymes indicating damage or inflammation; mouth sores; decreased appetite; coughing; difficulty breathing due to possible lung problems.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer is advanced or has spread, and previous treatments didn't work.
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I can take pills by mouth.
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I can perform daily activities with minimal assistance.
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My cholesterol and triglycerides levels are within the required range, or I am taking medication to manage them.
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My lung cancer has spread to my brain, but I've been stable for a month without new growths and am not on steroids.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1, 15, and 21 (course 1), day 1 (course 2), day 1 (course 3), and at progression
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 15, and 21 (course 1), day 1 (course 2), day 1 (course 3), and at progression
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maximum tolerated dose (MTD) of ceritinib and everolimus, defined as the highest dose level in which 6 patients were treated with at most 1 experiencing a dose limiting toxicity
Secondary outcome measures
Pharmacokinetic parameters of everolimus and ceritinib
Progression-free survival
Response rate
Other outcome measures
Levels of biomarkers as measured by immunohistochemistry, multiplex technology and/or enzyme-linked immunosorbent assays
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (ceritinib, everolimus)Experimental Treatment4 Interventions
Patients receive ceritinib PO QD and everolimus PO QD on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Everolimus
2010
Completed Phase 4
~1510
Ceritinib
2013
Completed Phase 3
~1030
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,687 Previous Clinical Trials
40,930,334 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,471 Total Patients Enrolled
George R BlumenscheinPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor can be sampled with a needle or biopsy for research.I have stage IIIB or IV ALK+ NSCLC and my cancer is getting worse despite treatment with an ALK inhibitor.I am not currently on cancer treatment and haven't been for the last 4 weeks.I am allergic to some ingredients in ceritinib medication.I can take pills by mouth.I can perform daily activities with minimal assistance.My diabetes is not well-controlled, with an HbA1c over 8% despite treatment.My cholesterol and triglycerides levels are within the required range, or I am taking medication to manage them.I do not have a history of severe lung scarring or diseases that have significantly affected my daily activities.My cancer is advanced or has spread, and previous treatments didn't work.My ALK-positive lung cancer has spread to my brain, but I don't have new symptoms and haven't needed more steroids recently.I am allergic to everolimus or similar medications.I have a digestive condition that affects how my body absorbs medication.I have serious heart issues or had a recent heart event.My lung cancer has spread to my brain, but I've been stable for a month without new growths and am not on steroids.I finished my cancer treatment (except ALK inhibitors) at least 21 days ago.I have previously taken everolimus or ceritinib.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (ceritinib, 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please detail the side effects of this medication?
"This trial is in its early stages, so not much is known about the safety or efficacy of the medication being tested. Our team at Power estimates that it falls somewhere around a 1 on a scale from 1 to 3."
Answered by AI
Are there any patients currently enrolled in this trial?
"The clinical trial in question is no longer actively recruiting patients, as the last update on clinicaltrials.gov was on June 27th, 2022. This study was first posted on June 22nd, 2016. There are 2598 other trials that are currently enrolling patients."
Answered by AI
How many individuals are taking part in this experiment?
"Unfortunately, this study is not taking any more participants at the moment. However, if you are still looking for trials to participate in, there are 2489 studies actively enrolling patients with non-small cell lung carcinoma and 109 Pharmacological Studies that are still recruiting."
Answered by AI
What does Pharmacological Study typically target?
"kidney transplant rejection is often treated with Pharmacological Study. Pharmacological Study can also improve outcomes for patients with waldenstrom macroglobulinemia, lung, and advanced carcinoid tumor."
Answered by AI
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