An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

Completed · Phase 2

Conditions studied: Unresectable Stage III, Stage IV Melanoma

In brief

The purpose of this study is to assess the objective response rate of lenvatinib in previously treated participants with American Joint Committee on Cancer (AJCC) unresectable Stage III or Stage IV melanoma and disease progression.

Key facts

Study ID

NCT01136967

Run by

Eisai Inc.

People needed

182

Starts

2010-08-01

Expected to finish

2014-11-01

Last updated by the study team

2019-11-13

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed diagnosis of melanoma.
• Unresectable Stage III or Stage IV melanoma.
• Evidence of disease progression according to RECIST 1.1 on prior regimen.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequately controlled blood pressure.
• Adequate renal function, bone marrow function, blood coagulation function, and liver function, as defined in the study protocol.

You may not qualify if…

• Melanoma of intraocular origin.
• 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.
• 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).
• Significant cardiovascular impairment.
• Bleeding disorder or a thrombotic disorder requiring anticoagulant therapy.
• Females who are pregnant or breastfeeding.
• Prolongation of QTc interval to greater than 480 msec.
• 24 hour urine protein greater than or equal to 1 gm.
• Active hemoptysis within 3 wks prior to the first dose of study drug.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Boulder, Colorado, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Denver, Colorado, United States
• Study site — Lakewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Lone Tree, Colorado, United States
• Study site — Longmont, Colorado, United States
• Study site — Parker, Colorado, United States
• Study site — Thornton, Colorado, United States
• Study site — Bonita Springs, Florida, United States
• Study site — Bradenton, Florida, United States
• Study site — Cape Coral, Florida, United States
• Study site — Clearwater, Florida, United States
• Study site — Englewood, Florida, United States
• Study site — Fort Myers, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Naples, Florida, United States
• Study site — North Port, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — Palm Harbor, Florida, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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