Spots Global Cancer Trial Database for A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
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Trial Identification
Brief Title: A Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of OSI-906 in Patients With Locally Advanced or Metastatic Adrenocortical Carcinoma
Study ID: NCT00924989
Conditions
Study Description
Brief Summary: A multicenter, randomized, double-blind, placebo-controlled, phase 3 study of single-agent OSI-906 in patients with locally advanced/metastatic Adrenocortical Carcinoma (ACC) who received at least 1 but no more than 2 prior drug regimens
Detailed Description: Patients will be randomized 2:1 to receive either single agent OSI-906 (Arm A) or placebo (Arm B) and will be stratified according to prior systemic cytotoxic chemotherapy for ACC, and Eastern Cooperative Oncology Group (ECOG) performance status, and use of \>= 1 oral antihyperglycemic therapy at randomization
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
TGen Clinical Research Service at Scottsdale Healthcare, Scottsdale, Arizona, United States
University of Southern California, Los Angeles, California, United States
UCLA, Los Angeles, California, United States
University of Colorado Denver Cancer Center, Aurora, Colorado, United States
University of Miami, Miami, Florida, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Dartmouth Medical School, Lebanon, New Hampshire, United States
Duke Clinical Cancer Trials Services, Durham, North Carolina, United States
Ohio State University, Columbus, Ohio, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Mary Crowley Cancer Research Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Royal North Shore Hospital Department of Endocrinology, St Leonards, New South Wales, Australia
St. Joseph's Hospital, Hamilton, Ontario, Canada
PMH - Princess Margaret Hospital, Toronto, Ontario, Canada
Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada
CHRU Lille, Clinique Endocrinologique Marc Linquette, Lille, , France
Centre Léon Bérard, Lyon, , France
Institut Paoli-Calmettes, Marseille, , France
Hôpital Cochin-Saint Vincent de Paul, Paris, , France
CHU Bordeaux - Hôpital Haut-Lévêque, Pessac, , France
Institut Gustave Roussy, Villejuif, , France
Charite Universitaetsmedizin, Berlin, , Germany
LMU München, Munich, , Germany
Universitaets Klinikum Wuerzburg, Wuerzburg, , Germany
Universita di Torino, Orbassano, , Italy
Università Cattolica del Sacro Cuore, Rome, , Italy
Academic Medical Center, Amsterdam, , Netherlands
Maxima Medisch Centrum (MMC), Eindhoven, , Netherlands
Erasmus MC Rotterdam, Rotterdam, , Netherlands
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie Oddzial w Gliwicach, Gliwice, , Poland
St. James' University hospital, Leeds, , United Kingdom
Royal Marsden NHS Trust, London, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
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