Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma

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Brief Title

Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma

Official Title

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

Brief 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.

      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.

Study Phase

Phase 2

Study Type


Primary Outcome

best overall response rate (BOR)


Adenoid Cystic Carcinoma



Study Arms / Comparison Groups

Description:  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.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

May 19, 2016

Completion Date

May 2023

Primary Completion Date

May 2023

Eligibility Criteria

        Inclusion Criteria:

          -  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.)

          -  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.

        Exclusion Criteria:

          -  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

          -  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.

          -  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

               -  Unstable angina (anginal symptoms at rest), new-onset angina within 3 months
                  before registration, or myocardial infarction within 6 months before

          -  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

          -  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

          -  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.




18 Years - N/A

Accepts Healthy Volunteers



Alan Ho, MD, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party


Study Sponsor

Memorial Sloan Kettering Cancer Center


 Eisai Inc.

Study Sponsor

Alan Ho, MD, PhD, Principal Investigator, Memorial Sloan Kettering Cancer Center

Verification Date

June 2022