An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
NCT ID: NCT01136967
Last Updated: 2019-11-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
182 participants
INTERVENTIONAL
2010-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1 (V600E BRAF negative)
Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma.
Lenvatinib
Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
Cohort 2 (V600E BRAF positive)
Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy.
Lenvatinib
Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
Interventions
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Lenvatinib
Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Unresectable Stage III or Stage IV melanoma.
3. Evidence of disease progression according to RECIST 1.1 on prior regimen.
4. Participants with brain metastases will be eligible if they have undergone complete surgical excision and are more then 1 month post surgery with no radiographic evidence of disease recurrence in the brain or have undergone stereotactic radio surgery (gamma knife procedure) and are more then 1 month post procedure and with no radiographic evidence of disease progression in the brain; and are asymptomatic, and discontinued corticosteroid treatment at least 30 days prior starting treatment.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Adequately controlled blood pressure.
7. Adequate renal function, bone marrow function, blood coagulation function, and liver function, as defined in the study protocol.
Exclusion Criteria
2. Leptomeningeal metastases or brain metastases except as for participants with brain metastases will be eligible if they have undergone complete surgical excision and are more then 1 month post surgery with no radiographic evidence of disease recurrence in the brain or have undergone stereotactic radio surgery (gamma knife procedure) and are more then 1 month post procedure and with no radiographic evidence of disease progression in the brain; and are asymptomatic, and discontinued corticosteroid treatment at least 30 days prior starting treatment.
3. More than 2 prior systemic anticancer regimen treatments including immunotherapies for unresectable Stage III or Stage IV disease (if BRAF V600E mutation negative) or not previously treated with BRAF V600E-targeted therapy or received in the past more than 2 prior systemic anticancer regimen treatments, including immunotherapies, in addition to a BRAF-V600E-targeted therapy (if BRAF V600E mutation positive).
4. Significant cardiovascular impairment.
5. Bleeding disorder or a thrombotic disorder requiring anticoagulant therapy.
6. Females who are pregnant or breastfeeding.
7. Prolongation of QTc interval to greater than 480 msec.
8. 24 hour urine protein greater than or equal to 1 gm.
9. Active hemoptysis within 3 wks prior to the first dose of study drug.
18 Years
99 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Eisai US Medical Services
Role: STUDY_DIRECTOR
Eisai Limited
Locations
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Birmingham, Alabama, United States
Tucson, Arizona, United States
Los Angeles, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Boulder, Colorado, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Lakewood, Colorado, United States
Littleton, Colorado, United States
Lone Tree, Colorado, United States
Longmont, Colorado, United States
Parker, Colorado, United States
Thornton, Colorado, United States
Bonita Springs, Florida, United States
Bradenton, Florida, United States
Cape Coral, Florida, United States
Clearwater, Florida, United States
Englewood, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Naples, Florida, United States
North Port, Florida, United States
Orlando, Florida, United States
Palm Harbor, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
Sebring, Florida, United States
Tampa, Florida, United States
Venice, Florida, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Burnsville, Minnesota, United States
Coon Rapids, Minnesota, United States
Edina, Minnesota, United States
Fridley, Minnesota, United States
Maplewood, Minnesota, United States
Minneapolis, Minnesota, United States
Saint Paul, Minnesota, United States
Woodbury, Minnesota, United States
Southaven, Mississippi, United States
St Louis, Missouri, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Lebanon, New Hampshire, United States
Morristown, New Jersey, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Springfield, Oregon, United States
Tualatin, Oregon, United States
Bethlehem, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Bartlett, Tennessee, United States
Franklin, Tennessee, United States
Gallatin, Tennessee, United States
Germantown, Tennessee, United States
Hermitage, Tennessee, United States
Lebanon, Tennessee, United States
Memphis, Tennessee, United States
Murfreesboro, Tennessee, United States
Nashville, Tennessee, United States
Smyrna, Tennessee, United States
Bedford, Texas, United States
Dallas, Texas, United States
Grapevine, Texas, United States
Houston, Texas, United States
Arlington, Virginia, United States
Fairfax, Virginia, United States
Gainesville, Virginia, United States
Leesburg, Virginia, United States
Winchester, Virginia, United States
Woodbridge, Virginia, United States
Vancouver, Washington, United States
Madison, Wisconsin, United States
Adelaide, , Australia
Malvern, , Australia
Newcastle, , Australia
North Sydney, , Australia
Perth, , Australia
Westmead, , Australia
Essen, , Germany
Hanover, , Germany
Heidelberg, , Germany
Kiel, , Germany
Mainz, , Germany
Tübingen, , Germany
Glasgow, , United Kingdom
London, , United Kingdom
Nottingham, , United Kingdom
Surrey, , United Kingdom
Countries
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Other Identifiers
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E7080-G000-206
Identifier Type: -
Identifier Source: org_study_id
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