Lenvatinib for Adenoid Cystic Carcinoma

Recruiting in Palo Alto (17 mi)

+6 other locations

Alan L. Ho, MD, PhD - MSK Head and Neck ...

Overseen byAlan L Ho, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Memorial Sloan Kettering Cancer Center

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing lenvatinib, a pill that aims to stop cancer cells from growing and reduce their blood supply, in patients with adenoid cystic carcinoma. Researchers want to see if it can shrink the tumors by at least one-quarter. Lenvatinib has shown promise in treating various solid tumors, including adenoid cystic carcinoma.

Eligibility Criteria

Adults with measurable adenoid cystic carcinoma, good performance status, and proper organ function can join. They must have tried other treatments without success and not used lenvatinib before. Participants need available tumor tissue for study, no recent major surgeries or bleeding events, stable blood pressure without severe medication, and agree to use contraception.

Inclusion Criteria

Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)

My blood counts meet the required levels without transfusions.

Subjects must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.

+15 more

Exclusion Criteria

I haven't had a stroke, clot, or embolism in the last 6 months.

I do not have symptoms from brain or spinal cord tumor spread.

I haven't had major surgery or a serious injury in the last 28 days.

+19 more

Participant Groups

The trial is testing the effects of an oral drug called Lenvatinib on shrinking adenoid cystic carcinoma tumors by at least one-quarter. It's a phase II study to see if this drug can slow down cancer growth by disrupting the cancer cells' functions and cutting off their blood supply.

1Treatment groups

Experimental Treatment

Group I: LenvatinibExperimental Treatment1 Intervention

All eligible patients will receive a starting lenvatinib dose of 24 mg daily taken orally for each 4-week cycle. Patients may remain on study until progression of disease or unacceptable toxicity. Alternatively, Lenvatinib may be dissolved in fluid per the Food and Drug Administration (FDA) label and administered orally or via a feeding tube.

Lenvatinib is already approved in United States, European Union, European Union for the following indications:

🇺🇸 Approved in United States as Lenvima for: