A Randomized Double-blind Phase III Study of RAD001 10 mg/d Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in the Treatment of Patients With Advanced Pancreatic Neuroendocrine Tumor (NET)
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Time to Progression Free Survival (PFS) Based as Per Investigator Using Kaplan-Meier Methodology
Progression of disease is defined as the time from study start to the date of first documented progression of disease or death due to any cause. Progression of disease is defined by RECIST criteria: Progression = 20% increase in the sum of the longest diameter of all target lesions, from the smallest sum of longest diameter of all target lesions recorded at or after baseline; or a new lesion; or progression of non-target lesions.
Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 17 August 2007, until cut-off date 28 February 2010
No
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
United States: Food and Drug Administration
CRAD001C2324
NCT00510068
July 2007
December 2017
Name | Location |
---|---|
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
The Center for Cancer and Blood Disorders | Fort Worth, Texas 76104 |
Mayo Clinic - Rochester | Rochester, Minnesota 55905 |
Pacific Cancer Medical Center, Inc. | Anaheim, California 92801 |
Levine Cancer Institute | Charlotte, North Carolina 28211 |
Hematology Oncology Associates of Northern New Jersey PA Dept of Hem-Onc of Northern NJ | Morristown, New Jersey 07962 |
University of South Alabama / Mitchell Cancer Institute Deptof Mitchell Cancer Inst(2) | Mobile, Alabama 36688 |
University of Louisville / James Graham Brown Cancer Center SC | Louisville, Kentucky 40202 |
MD Anderson Cancer Center/University of Texas Dept of MD Anderson CancerCent | Houston, Texas 77030-4009 |
Cedars Sinai Medical Center SC-2 | Los Angeles, California 90048 |
University of California at Los Angeles UCLA (3) | Los Angeles, California 90095 |
University of California San Francisco Dept. of UCSF Comp. Cancer | San Francisco, California 94143-0128 |
Kaiser Permanente Northwest Franklin Medical Offices | Denver, Colorado |
H. Lee Moffitt Cancer Center/University of South Florida Malignant Hematology Clinic | Tampa, Florida 33612 |
Indiana University Health Goshen Center for Cancer Dept. of Indiana Univ. Cancer | Indianapolis, Indiana 46202 |
University of Iowa Medical Center Dept. of Iowa Medical Center | Iowa City, Iowa 52242 |
LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Dept. of Neuroendocrine Clinic | New Orleans, Louisiana 70115 |
Boston Medical Center BMC | Boston, Massachusetts 02118 |
Wayne State University/Karmanos Cancer Institute Dept.of KarmanosCancerInst (4) | Detroit, Michigan 48201 |
Littleton Regional Hospital Dept. of Hematology/Oncology | Littleton, New Hampshire 03561 |
Columbia University Medical Center- New York Presbyterian Dept. of Columbia Med. Center | New York, New York 10032 |
Ohio State Comprehensive Cancer Center/James Cancer Hospital Dept. of OHSU Medical Center | Columbus, Ohio 43210 |
Oregon Health & Science University Dept. of OHSU (3) | Portland, Oregon 97239 |
St. Luke's Hospital and Health Network St. Luke's Cancer Network | Bethlehem, Pennsylvania |
University of Pittsburgh Medical Center Hillman Cancer Center | Pittsburgh, Pennsylvania |