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Trial record 10 of 128 for:    Adenoid Cystic Carcinoma

Testing Lenvatinib in Patients With Adenoid Cystic Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02780310
Recruitment Status : Active, not recruiting
First Posted : May 23, 2016
Last Update Posted : June 4, 2019
Eisai Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Adenoid Cystic Carcinoma Drug: Lenvatinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Lenvatinib in Patients With Progressive, Recurrent/Metastatic Adenoid Cystic Carcinoma
Study Start Date : May 19, 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adenoids
Drug Information available for: Lenvatinib

Arm Intervention/treatment
Experimental: Lenvatinib
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.
Drug: Lenvatinib

Primary Outcome Measures :
  1. best overall response rate (BOR) [ Time Frame: 8 weeks ]
    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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02780310

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United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Memorial Sloan Kettering at Mercy Medical Center
Rockville Centre, New York, United States
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Eisai Inc.
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Principal Investigator: Alan Ho, MD, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center Identifier: NCT02780310     History of Changes
Other Study ID Numbers: 15-327
First Posted: May 23, 2016    Key Record Dates
Last Update Posted: June 4, 2019
Last Verified: June 2019
Keywords provided by Memorial Sloan Kettering Cancer Center:
Additional relevant MeSH terms:
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Carcinoma, Adenoid Cystic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action