Status:
COMPLETED
An Open-Label, 2-Cohort, Multicenter, Study of Lenvatinib in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma
Lead Sponsor:
Eisai Inc.
Conditions:
Unresectable Stage III
Stage IV Melanoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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 me...
Detailed Description
This was a Phase 2, multicenter, open-label, 2-cohort, 2-stage study that assessed the ORR of lenvatinib in previously treated participants with AJCC unresectable Stage III or Stage IV melanoma and di...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
182 Patients enrolled
Trial Details
Trial ID
NCT01136967
Start Date
August 1 2010
End Date
November 1 2014
Last Update
November 13 2019
Active Locations (95)
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1
Birmingham, Alabama, United States
2
Tucson, Arizona, United States
3
Los Angeles, California, United States
4
San Francisco, California, United States