← Back to Search

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

Must not have

Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks including chemotherapy, radiation therapy, antibody based therapy, etc.

Patients with known hypersensitivity to any of the excipients of ceritinib (microcrystalline cellulose, mannitol, crospovidone, colloidal silicon dioxide and magnesium stearate)

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

No Placebo-Only Group

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.

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.

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 below

Select...

My cancer is advanced or has spread, and previous treatments didn't work.

Select...

I can take pills by mouth.

Select...

I can perform daily activities with minimal assistance.

Select...

My cholesterol and triglycerides levels are within the required range, or I am taking medication to manage them.

Select...

My lung cancer has spread to my brain, but I've been stable for a month without new growths and am not on steroids.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not currently on cancer treatment and haven't been for the last 4 weeks.

Select...

I am allergic to some ingredients in ceritinib medication.

Select...

I do not have a history of severe lung scarring or diseases that have significantly affected my daily activities.

Select...

I am allergic to everolimus or similar medications.

Select...

I have a digestive condition that affects how my body absorbs medication.

Select...

I have serious heart issues or had a recent heart event.

Select...

I have previously taken everolimus or ceritinib.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 15, and 21 (course 1), day 1 (course 2), day 1 (course 3), and at progression for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Pharmacokinetic parameters of everolimus and ceritinib

Progression-free survival

Response rate

Other study objectives

Levels of biomarkers as measured by immunohistochemistry, multiplex technology and/or enzyme-linked immunosorbent assays

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Ceritinib

2013

Completed Phase 3

~1030

Everolimus

2010

Completed Phase 4

~1510