A Randomized, Double-blind, Multicenter, Phase III Study of Everolimus (RAD001) Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced NET of GI or Lung Origin
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression free survival (PFS)
The estimated average duration from randomization date is at least 5-8.5 months until disease progression. PFS is defined as the time from randomization to the date of the first documented tumor progression as per modified RECIST 1.0 or death from any cause, whichever comes first. Progression is assessed by CT and/or MRI.
From date of randomization to progression or death
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CRAD001T2302
NCT01524783
March 2012
January 2018
Name | Location |
---|---|
Georgetown University/Lombardi Cancer Center | Washington, District of Columbia 20007-2197 |
US Oncology Central Monitoring | Dallas, Texas 75246 |
University of South Alabama / Mitchell Cancer Institute Dept. of Mitchell Cancer Inst. | Mobile, Alabama 36688 |
University of Iowa Hospitals & Clinics Univ Iowa 2 | Iowa City, Iowa 52242 |
Dana Farber Cancer Institute SC | Boston, Massachusetts 02115 |
Washington Hospital Center Wash Hospital | Washington, District of Columbia 20010 |
MD Anderson Cancer Center/University of Texas UT MD Anderson Cancer Ctr | Houston, Texas 77030-4009 |
Montefiore Medical Center MMC | Bronx, New York 10467 |
Memorial Sloan Kettering Cancer Center MSKCC SC | New York, New York 10021 |
Cedars Sinai Medical Center SC | Los Angeles, California 90048 |
Mercy Medical Center Mercy Medical SC | Baltimore, Maryland 21202 |
St. Luke's Hospital and Health Network St Luke | Bethlehem, Pennsylvania |
USC/Kenneth Norris Comprehensive Cancer Center USC/Norris | Los Angeles, California 90033 |
Scripps Clinic Regulatory | La Jolla, California 92121 |
University of California San Diego Regulatory | La Jolla, California 92093-0658 |
University of Colorado SC | Aurora, Colorado 80045 |
H. Lee Moffitt Cancer Center/University of South Florida HLM | Tampa, Florida 33612 |
University of Chicago Medical Center UC SC | Chicago, Illinois 60546 |
Indiana University Health Goshen Center for Cancer IU Health - SC | Indianapolis, Indiana 46202 |
University of Kansas Cancer Center Univ Kansas | Kansas City, Kansas 66160 |
Ochsner Clinic Foundation Ochsner | New Orleans, Louisiana 70121 |
University of Maryland Medical Center SC | Baltimore, Maryland 21201 |
Massachusetts General Hospital Study Coordinator | Boston, Massachusetts 02114 |
Mayo Clinic - Rochester Dept. of Mayo Clinic (1) | Rochester, Minnesota 55905 |
Research Medical Center CACZ885M2301 | Kansas City, Missouri 64132 |
University of Oklahoma Health Sciences Center SC -2 | Oklahoma City, Oklahoma 73104 |
Oregon Health & Science University OH&SU | Portland, Oregon 97239 |
Penn State University / Milton S. Hershey Medical Center SC | Hershey, Pennsylvania 17033-0850 |
Fox Chase Cancer Center FCCC 2 | Philadelphia, Pennsylvania 19111-2497 |
Cancer Centers of the Carolinas SC - 2 | Greenville, South Carolina 29605 |
Vanderbilt University Medical Center Vanderbilt Med Ctr | Nashville, Tennessee 37232 |
University of Texas Southwestern Medical Center UTSW 4 | Dallas, Texas 75390-8527 |
Texas Oncology, P.A. TX Onc Baylor | Dallas, Texas 75251 |
Texas Oncology, P.A. Texas Oncology - Amarillo | Dallas, Texas 75251 |
Scott and White Memorial Hospital Scott and White | Temple, Texas 76508-0002 |
University of Virginia Health Systems SC-3 | Charlottesville, Virginia 22908-0334 |
Eastern Virginia Medical School--Strelitz Diabetes Institute | Norfolk, Virginia 23510 |
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc | Madison, Wisconsin 53792-6164 |