Lenvatinib + Everolimus for Neuroendocrine Tumors

Recruiting in Palo Alto (17 mi)

Overseen byNageshwara V. Dasari

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial studies how well lenvatinib and everolimus work in treating patients with advanced carcinoid tumors that cannot be removed by surgery. These medications are taken by mouth and aim to stop cancer cells from growing by blocking essential enzymes. The trial will evaluate how effective and safe these drugs are for these patients. Both lenvatinib and everolimus have shown effectiveness in treating various cancers.

Research Team

Nageshwara V. Dasari

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with advanced, unresectable carcinoid tumors. Eligible participants must have well-differentiated tumors, may have MEN1 syndrome, and show disease progression over the last year. They should be in good physical condition (ECOG 0-1), not pregnant, able to swallow pills, without HIV or hepatitis B/C, and free from other cancers in the past 3 years.

Inclusion Criteria

Your platelet count is at least 100 billion per liter.

Written informed consent must be obtained prior to any screening procedures.

Your hemoglobin level is at least 9 grams per deciliter.

See 22 more

Exclusion Criteria

Patients with concurrent severe and/or uncontrolled concurrent medical conditions that could compromise participation in the study

I haven't had major surgery in the last 3 weeks or still have major side effects from it.

I am willing and able to follow the study's requirements.

See 16 more

Treatment Details

Interventions

Everolimus (Kinase Inhibitor)
Lenvatinib (Kinase Inhibitor)

Trial OverviewThe study tests lenvatinib and everolimus' effectiveness on advanced carcinoid tumors that can't be surgically removed. These drugs aim to inhibit tumor growth by blocking enzymes necessary for cell proliferation.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (lenvatinib, everolimus)Experimental Treatment2 Interventions

Patients receive lenvatinib PO daily and everolimus PO daily on days 1-28. Treatments repeat every 28 days in the absence of disease progression or unacceptable toxicity.