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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

Interventions

OSI-906
Placebo

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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