546
Participants
Start Date
April 30, 2010
Primary Completion Date
October 31, 2013
Study Completion Date
October 31, 2013
Everolimus
Everolimus (labeled as RAD001) was formulated as tablets of 2.5 mg strength and blisterpacked in units of 10 tablets.
Everolimus Placebo
Everolimus Placebo matched to the everolimus 2.5 mg tablet strength was blister-packed in units of 10 tablets. Matching placebo tablets were formulated to be indistinguishable from the everolimus tablets. Everolimus placebo was taken as a daily oral dose of 7.5 mg and was defined as the control drug.
Best Supportive Care (BSC)
BSC was defined as drug or non-drug therapies, nutritional support, physical therapy or anything that the Investigator believed to be in the patient's best interest, but excluding other antineoplastic treatments. BSC administered to the patient throughout the study was to be reported on the Concomitant Medication/Significant Non-Drug Therapy electronic case report from (eCRF). Permitted BSC treatments during the study included, but were not limited to, the following: Pain medication to allow the patient to be as comfortable as possible, Bisphosphonates for bone metastases, Localized radiotherapy, for the treatment of pre-existing, painful bone metastases, Nutritional support or appetite stimulants (i.e. megestrol) as recommended by the Investigator, Oxygen therapy and blood products or transfusions
Novartis Investigative Site, Taipei
Novartis Investigative Site, Brussels
Novartis Investigative Site, Vienna
Novartis Investigative Site, Brussels
Novartis Investigative Site, Camperdown
Novartis Investigative Site, Westmead
Novartis Investigative Site, Kogarah
Novartis Investigative Site, Edegem
Novartis Investigative Site, Leuven
Novartis Investigative Site, Parkville
Novartis Investigative Site, Heidelberg
Novartis Investigative Site, Debrecen
Novartis Investigative Site, Graz
Novartis Investigative Site, Szombathely
Novartis Investigative Site, Taipei
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Bangkok
Novartis Investigative Site, Berlin
Novartis Investigative Site, Marseille Cédex 5
Novartis Investigative Site, Córdoba
Novartis Investigative Site, Caen Cedex9
University of Rochester Medical Center Rochester, Rochester
Novartis Investigative Site, Rozzano
Novartis Investigative Site, Milan
Novartis Investigative Site, Hamburg
Novartis Investigative Site, Dijon
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care, Roanoke
Novartis Investigative Site, Pavia
Novartis Investigative Site, Madrid
Novartis Investigative Site, Hanover
Novartis Investigative Site, Pamplona
Novartis Investigative Site, Bordeaux
Novartis Investigative Site, Aviano
Novartis Investigative Site, Linkou District
Novartis Investigative Site, Montpellier
Novartis Investigative Site, Padua
Novartis Investigative Site, Chambray-lès-Tours
Novartis Investigative Site, Bologna
Novartis Investigative Site, Taichung
Novartis Investigative Site, Modena
Novartis Investigative Site, Saint-Priest-en-Jarez
Novartis Investigative Site, Nantes
Novartis Investigative Site, Essen
Novartis Investigative Site, Petah Tikva
Novartis Investigative Site, Reims
Novartis Investigative Site, Thessaloniki
Novartis Investigative Site, Lille
Novartis Investigative Site, Frankfurt
Novartis Investigative Site, Clermont-Ferrand
Midwest Cancer Care Physicians Research Medical Center, Kansas City
Novartis Investigative Site, Strasbourg
Novartis Investigative Site, Mannheim
Novartis Investigative Site, Lyon
Novartis Investigative Site, Tainan City
Novartis Investigative Site, Foggia
Highlands Oncology Group Dept of Highlands Oncology Grp, Fayetteville
Novartis Investigative Site, Esslingen am Neckar
Methodist Charlton Cancer Center Methodist, Dallas
Novartis Investigative Site, Rouen
Cancer Care Centers of South Texas / HOAST CCC of So. TX- San Antonio, San Antonio
Texas Cancer Center - Abilene, Abilene
Novartis Investigative Site, Frattamaggiore
Novartis Investigative Site, Amiens
Novartis Investigative Site, Napoli
Novartis Investigative Site, München
Novartis Investigative Site, Benevento
Novartis Investigative Site, Niaosong Township
Novartis Investigative Site, Avignon
VA Sierra Nevada Health Care System Dept. of VA Sierra Nevada HCS, Reno
Novartis Investigative Site, Palermo
Novartis Investigative Site, Clichy
Compassionate Cancer Care Medical Group CCCMG, Fountain Valley
Queen's Medical Center Queens Cancer Center, Honolulu
Novartis Investigative Site, Würzburg
Northwest Cancer Specialists Rose Quarter Cancer Center, Portland
Novartis Investigative Site, Beijing
Novartis Investigative Site, Nanjing
Novartis Investigative Site, Hangzhou
Novartis Investigative Site, Guangzhou
Novartis Investigative Site, Chengdu
Novartis Investigative Site, Xi’an
Novartis Investigative Site, Ramat Gan
University of California San Diego - Moores Cancer Center SC - 3, La Jolla
California Pacific Medical Center California Pacific Med, San Francisco
Rocky Mountain Cancer Centers RMCC - Denver-Midtown (4), Greenwood Village
St. Luke's Hospital and Health Network St. Luke's Cancer Network (2), Bethlehem
Novartis Investigative Site, Hong Kong
Novartis Investigative Site, Liouying Township
The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Dept. of SKCC @ JHU, Baltimore
Massachusetts General Hospital Dept. of Mass General Hospital, Boston
University of Texas Southwestern Medical Center DeptofSimmons Cancer Center(3), Dallas
University of Washington Cancer Care SC, Seattle
Novartis Investigative Site, Innsbruck
Novartis Investigative Site, London
Novartis Investigative Site, Toronto
Novartis Investigative Site, Montreal
Novartis Investigative Site, Montreal
Novartis Investigative Site, Nice
Novartis Investigative Site, Göttingen
Novartis Investigative Site, Leipzig
Novartis Investigative Site, Athens
Novartis Investigative Site, Larissa
Novartis Investigative Site, Budapest
Novartis Investigative Site, Szeged
Novartis Investigative Site, Roma
Novartis Investigative Site, Roma
Novartis Investigative Site, Nagoya
Novartis Investigative Site, Chiba
Novartis Investigative Site, Kashiwa
Novartis Investigative Site, Matsuyama
Novartis Investigative Site, Fukuoka
Novartis Investigative Site, Fukuoka
Novartis Investigative Site, Iizuka
Novartis Investigative Site, Gifu
Novartis Investigative Site, Ōgaki
Novartis Investigative Site, Kanazawa
Novartis Investigative Site, Yokohama
Novartis Investigative Site, Kumamoto
Novartis Investigative Site, Sendai
Novartis Investigative Site, Osaka
Novartis Investigative Site, Sayama
Novartis Investigative Site, Chuo-ku
Novartis Investigative Site, Mitaka
Novartis Investigative Site, Shinagawa-ku
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Seoul
Novartis Investigative Site, Sabadell
Novartis Investigative Site, Barcelona
Novartis Investigative Site, Barcelona
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY