A Phase II Trial of RAD001 Plus Bevacizumab in the Treatment of Patients With Metastatic Melanoma
All patients will begin treatment with the same doses of RAD001 and bevacizumab. Patients
will receive 6 weeks of treatment, followed by re evaluation. Patients with objective
response or stable disease will continue treatment until disease progression.
During the study, all patients will receive 10 mg of RAD001 orally daily and 15 mg/kg of
bevacizumab intravenously (IV) once every 3 weeks.
Fifty-five patients will be enrolled in this multi-centered study
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival
Length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
13 months
No
John D. Hainsworth, M.D.
Study Chair
Sarah Cannon Research Institute
United States: Food and Drug Administration
SCRI MEL 16
NCT00591734
January 2008
October 2011
Name | Location |
---|---|
Florida Hospital Cancer Institute | Orlando, Florida 32804 |
South Texas Oncology and Hematology | San Antonio, Texas 78229 |
Florida Cancer Specialists | Fort Myers, Florida 33901 |
Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
Virginia Cancer Institute | Richmond, Virginia 23230 |
Methodist Cancer Center | Omaha, Nebraska 68114 |
Center for Cancer and Blood Disorders | Bethesda, Maryland 20817 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Gulfcoast Oncology Associates | St. Petersburg, Florida 33705 |
St. Louis Cancer Care | Chesterfield, Missouri 63017 |
Tennessee Oncology, PLLC | Clarksville, Tennessee 37043 |
Watson Clinic Center for Cancer Care and Research | Lakeland, Florida 33805 |
Oncology Hematology Associates of SW Indiana | Evansville, Indiana 47714 |
Consultants in Medical Oncology and Hematology | Drexel Hill, Pennsylvania 19026 |
Chattanooga Oncology & Hematology Associates | Chattanooga, Tennessee 37404 |