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Adenoid Cystic CarcinomaPhase 2NCT02780310

Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma

A Phase 2 study testing Lenvatinib in people with Adenoid Cystic Carcinoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to find out what effects, good and/or bad, the drug lenvatinib has on the patient and on adenoid cystic carcinoma. This type of cancer study is called a phase II study. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adenoid Cystic Carcinoma
What is being tested?
Lenvatinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
6 sitesUnited States
Study dates
19 May 2016to May 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must have pathologically or cytologically confirmed adenoid cystic carcinoma. Cancers arising from non-salivary gland primary sites are allowed.
  • Patients must have recurrent and/or metastatic disease not amenable to potentially curative surgery or radiotherapy.
  • At least 2 weeks must have elapsed since the end of prior systemic treatment (4 weeks for bevacizumab- containing regimens) or radiotherapy with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia, lymphopenia, or hypothyroidism). Any number of prior therapies for recurrent/metastatic ACC are allowed.
  • Patients must have RECIST v1.1 measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan.
  • Patients must have documentation of a new or progressive lesion on a radiologic imaging study performed within 6 months prior to study enrollment (progression of disease over any interval is allowed) and/or new/worsening disease related symptoms within 6 months prior to study enrollment. Note: This assessment will be performed by the treating investigator. Evidence of progression by RECIST criteria is not required.
  • Patients must have archival tissue from the primary tumor or metastases available for correlative studies. Either a paraffin block or twenty unstained slides are acceptable. (If less than twenty unstained slides are available, the patient may be able to participate at the discretion of the investigator.)
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  • Age ≥ 18 years
  • ECOG performance status <2 (Karnofsky >60%)
  • Adequate bone marrow, liver and renal function (as suggested for lenvatinib studies).
  • Total bilirubin ≤ 1.5 x the upper limits of normal (ULN)
  • Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  • Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer)
  • Serum creatinine ≤ 1.5 x the ULN or calculated creatinine clearance ≥ 60 ml/min
  • Platelet count ≥ 100,000 /mm3, hemoglobin (Hb) ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1500/mm3. Blood transfusion to meet the inclusion criteria will not be allowed.
  • 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.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 2 weeks prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
  • Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the consent form until at least 3 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
  • Subject must be able to swallow and retain oral medication.

Who cannot join

  • Concurrent anti-cancer therapy (chemotherapy, definitive radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than study treatment. Concurrent therapy with bisphosphonates or denosumab for bone metastases is allowed. Palliative radiation to non-target lesions is also allowed.
  • Prior use of lenvatinib.
  • Uncontrolled hypertension (systolic pressure >140 mm Hg or diastolic pressure > 90 mm Hg [NCI-CTCAE v4.0] on repeated measurement) despite optimal medical management.
  • Concurrent use of another investigational drug or device (i.e., outside of study treatment) during, or within 4 weeks of trial entry (signing of the informed consent form).
  • Clinically significant proteinuria:
  • Subjects having >1+ proteinuria on urinalysis will undergo 24-hour urine collection for quantitative assessment of proteinuria. Subjects with urine protein ≥1 g/24-hour will be ineligible.
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  • Active or clinically significant cardiac disease including:
  • Congestive heart failure - New York Heart Association (NYHA) > Class II.
  • Active coronary artery disease that is not medically treated.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin.
  • Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before registration, or myocardial infarction within 6 months before registration.
  • Subjects with thrombotic, embolic, venous, or arterial events, such as cerebrovascular accident (including transient ischemic attacks) deep vein thrombosis or pulmonary embolism within 6 months of study treatment start.
  • Symptomatic metastatic brain or leptomeningeal tumors (asymptomatic or treated metastatic brain or leptomeningeal tumors are allowed).
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication.
  • Evidence or history of bleeding diathesis or coagulopathy.
  • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
  • Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin) is not allowed if the medication dose and/or INR/PTT are not considered stable by the treating physician. If the dose and/or INR/PTT are stable, therapeutic anticoagulation with Vitamin-K antagonists is allowed with close monitoring. Anticoagulation with heparin or heparinoids is allowed.
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
  • Active infection that would impair the ability of the patient to receive study treatment
  • Presence of a non-healing wound or non-healing ulcer that is not tumor related.
  • Renal failure requiring hemo-or peritoneal dialysis.
  • Patients with seizure disorder requiring medication.
  • Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • History of organ allograft (including corneal transplant).
  • Any malabsorption condition.
  • Women who are pregnant or breast-feeding.
  • Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Memorial Sloan Kettering Cancer Center

    Basking Ridge, New Jersey

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York

Other trials in United States

About this study

Official title: A Phase II Study of Lenvatinib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma

The purpose of this study is to find out what effects, good and/or bad, the drug lenvatinib has on the patient and on adenoid cystic carcinoma. This type of cancer study is called a phase II study. Researchers hope to learn if the study drug will shrink the cancer by at least one-quarter compared to its present size.

Lenvatinib is an oral medication that can interfere with cancer cell growth and reduce the growth of blood vessels around tumors. This study will help find out if lenvatinib is a useful drug for treating patients with adenoid cystic carcinomas.

Being tested
Lenvatinib
Keywords
Lenvatinib, 15-327
Medical subject headings
Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02780310
Study groupRoleWhat they receive
LenvatinibExperimentalAll 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.
Receives: Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. best overall response rate (BOR)

    Response will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1)

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2016 (estimated)
  2. Study start19 May 2016
  3. Primary completionMay 2027 (estimated)
  4. Study completionMay 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02780310
Sponsor's protocol ID
15-327
Status last verified
Jun 2026
First submitted
19 May 2016
Last updated
3 Jun 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Lenvatinib in people with Adenoid Cystic Carcinoma, run by Memorial Sloan Kettering Cancer Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

best overall response rate (BOR) (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02780310.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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