Testing Lenvatinib in Patients with Adenoid Cystic Carcinoma

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT02780310

This clinical trial is exploring the effects of the drug lenvatinib on adenoid cystic carcinoma, a type of cancer. The study aims to see if lenvatinib can shrink the cancer by at least 25%.

Patient Parameters

Program Overview

The purpose of this study is to find out how the drug lenvatinib affects patients with adenoid cystic carcinoma, a type of cancer. Researchers want to see if lenvatinib can shrink the cancer by at least one-quarter of its current size. Lenvatinib is a pill that may slow down cancer cell growth and reduce the blood supply to tumors. This study will help determine if lenvatinib is a useful treatment for people with adenoid cystic carcinoma.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of adenoid cystic carcinoma, including cancers from non-salivary gland sites.
  • Cancer must have returned or spread and cannot be treated with surgery or radiotherapy.
  • At least 2 weeks must have passed since the last cancer treatment, with recovery from any side effects.
  • Must have measurable cancer that can be tracked by scans.
  • Must have a new or worsening cancer lesion or symptoms within 6 months before joining the study.
  • Must provide a sample of the tumor tissue for study purposes.
  • Must be 18 years or older.
  • Must be in good general health with a performance status score of less than 2.
  • Must have adequate blood, liver, and kidney function based on specific tests.
  • Must be able to understand and sign a consent form.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Must agree to use effective birth control during the study and for 3 months after the last dose.
  • Must be able to swallow pills.

Exclusion Criteria

  • Cannot be receiving other cancer treatments besides the study drug.
  • Cannot have used lenvatinib before.
  • Cannot have uncontrolled high blood pressure.
  • Cannot be using another experimental drug or device.
  • Cannot have significant protein in the urine.
  • Cannot have serious heart problems or recent heart attacks.
  • Cannot have had recent blood clots or strokes.
  • Cannot have untreated or symptomatic brain tumors.
  • Cannot have had major surgery or injury recently.
  • Cannot have bleeding disorders or recent severe bleeding.
  • Cannot be on unstable blood thinners.
  • Cannot have active infections like HIV or hepatitis.
  • Cannot have a non-healing wound or ulcer.
  • Cannot have kidney failure requiring dialysis.
  • Cannot have a seizure disorder needing medication.
  • Cannot have lung disease with symptoms.
  • Cannot have had an organ transplant.
  • Cannot have conditions affecting absorption of medication.
  • Cannot be pregnant or breastfeeding.
  • Cannot have any condition that makes participation unsafe.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering Cancer CenterBasking RidgeNew Jersey
Memorial Sloan Kettering Monmouth07748MiddletownNew Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk11725CommackNew York
Memorial Sloan Kettering Westchester10604HarrisonNew York
Memorial Sloan Kettering Cancer Center10065New YorkNew York
Memorial Sloan Kettering at Mercy Medical CenterRockville CentreNew York

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