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



Status:Completed
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:August 2010
End Date:November 2014

Use our guide to learn which trials are right for you!

An Open-Label, 2-Cohort, Multicenter, Phase 2 Study of E7080 (Lenvatinib) in Previously Treated Subjects With Unresectable Stage III or Stage IV Melanoma

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.

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 disease progression. Cohort 1 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, and is referred to as
Cohort 1 or V600E BRAF negative. Other less common BRAF activating mutations were allowed as
long as the participant did not receive a BRAF-targeted therapy. Cohort 2 enrolled
participants harboring the activating BRAF mutations (mainly the V600E mutation) with
disease progression following BRAF V600E-targeted therapy, and is referred to as Cohort 2 or
V600E BRAF positive. Eligible participants had measurable disease according to RECIST 1.1.

Inclusion Criteria:

1. Histologically confirmed diagnosis of melanoma.

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:

1. Melanoma of intraocular origin.

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.
We found this trial at
80
sites
?
mi
from
Bartlett, TN
Click here to add this to my saved trials
?
mi
from
Adelaide,
Click here to add this to my saved trials
?
mi
from
Arlington, VA
Click here to add this to my saved trials
?
mi
from
Aurora, CO
Click here to add this to my saved trials
?
mi
from
Bedford, TX
Click here to add this to my saved trials
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
?
mi
from
Bonita Springs, FL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Boulder, CO
Click here to add this to my saved trials
?
mi
from
Bradenton, FL
Click here to add this to my saved trials
?
mi
from
Brimingham, AL
Click here to add this to my saved trials
?
mi
from
Burnsville, MN
Click here to add this to my saved trials
?
mi
from
Cape Coral, FL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
?
mi
from
Coon Rapids, MN
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
?
mi
from
Detroit, MI
Click here to add this to my saved trials
?
mi
from
Edina, MN
Click here to add this to my saved trials
?
mi
from
Englewood, FL
Click here to add this to my saved trials
?
mi
from
Eugene, OR
Click here to add this to my saved trials
?
mi
from
Fairfax, VA
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Fridley, MN
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
?
mi
from
Gainesville, VA
Click here to add this to my saved trials
?
mi
from
Gallatin, TN
Click here to add this to my saved trials
?
mi
from
Germantown, TN
Click here to add this to my saved trials
?
mi
from
Grapevine, TX
Click here to add this to my saved trials
?
mi
from
Henderson, NV
Click here to add this to my saved trials
?
mi
from
Hermitage, TN
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
?
mi
from
LasVegas, NV
Click here to add this to my saved trials
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
?
mi
from
Lebanon, TN
Click here to add this to my saved trials
?
mi
from
Leesburg, VA
Click here to add this to my saved trials
?
mi
from
Littleton, CO
Click here to add this to my saved trials
?
mi
from
Lone Tree, CO
Click here to add this to my saved trials
?
mi
from
Longmont, CO
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Madison, WI
Click here to add this to my saved trials
?
mi
from
Maplewood, MN
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
?
mi
from
Morristown, NJ
Click here to add this to my saved trials
?
mi
from
Murfreesboro, TN
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
?
mi
from
Nashville, TN
Click here to add this to my saved trials
?
mi
from
New York, NY
Click here to add this to my saved trials
?
mi
from
North Port, FL
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Parker, CO
Click here to add this to my saved trials
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
?
mi
from
Port Charlotte, FL
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Sebring, FL
Click here to add this to my saved trials
?
mi
from
Smyrna, TN
Click here to add this to my saved trials
?
mi
from
Southaven, MS
Click here to add this to my saved trials
?
mi
from
Springfield, OR
Click here to add this to my saved trials
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
?
mi
from
St.Paul, MN
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Thornton, CO
Click here to add this to my saved trials
?
mi
from
Tualatin, OR
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
Vancouver, WA
Click here to add this to my saved trials
?
mi
from
Venice, FL
Click here to add this to my saved trials
?
mi
from
Winchester, VA
Click here to add this to my saved trials
?
mi
from
Woodbridge, VA
Click here to add this to my saved trials
?
mi
from
Woodbury, MN
Click here to add this to my saved trials