Spots Global Cancer Trial Database for Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
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Trial Identification
Brief Title: Study of AG-120 in Previously Treated Advanced Cholangiocarcinoma With IDH1 Mutations (ClarIDHy)
Official Title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study of AG-120 in Previously-treated Subjects With Nonresectable or Metastatic Cholangiocarcinoma With an IDH1 Mutation
Study ID: NCT02989857
Study Description
Brief Summary: Study AG120-C-005 is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study of orally administered AG-120. Participants, all personnel involved in the evaluation of participants' response to treatment (e.g., Investigators, study coordinators, study pharmacists), and designated Sponsor team members will be blinded to study treatment. Participants are required to have a histologically-confirmed diagnosis of isocitrate dehydrogenase-1 (IDH1) gene-mutated cholangiocarcinoma that is not eligible for curative resection, transplantation, or ablative therapies prior to enrollment. IDH1 mutation testing will be performed at participating investigative sites. Participants must have progression of disease and have received at least 1 but not more than 2 prior treatment regimens for advanced disease (nonresectable or metastatic). All participants must have received either a gemcitabine or a 5 fluorouracil (5-FU) based chemotherapy regimen.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Mayo Cancer Center, Scottsdale, Arizona, United States
City of Hope Cancer Center, Duarte, California, United States
University of California, Irvine, Irvine, California, United States
University of Southern California, Los Angeles, California, United States
University of California, San Francisco, San Francisco, California, United States
Mayo Cancer Center, Jacksonville, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago Medical Center, Chicago, Illinois, United States
Johns Hopkins University, Baltimore, Maryland, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan, Ann Arbor, Michigan, United States
Mayo Cancer Center, Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Columbia University, New York, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Gibbs Cancer Center, Spartanburg, South Carolina, United States
Sarah Cannon Research Institute, Nashville, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
University of Texas, SouthWestern, Dallas, Texas, United States
UT MD Anderson Cancer Center, Houston, Texas, United States
University of Utah, Huntsman Cancer Institute, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
University of Wisconsin, Carbone Cancer Center, Madison, Wisconsin, United States
Universite de Franche-Comte, Besançon, , France
Centre de Lutte Contre le Cancer (CLCC) - Institut Bergonie, Bordeaux, , France
Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer, Rennes, , France
Institut Gustave Roussy, Villejuif, , France
Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS Candiolo), Candiolo, , Italy
Istituto Scientifico Universitario San Raffaele, Milano, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei University Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Seoul, St. Mary's Hospital, Seoul, , Korea, Republic of
National Cancer Center, Seoul, , Korea, Republic of
Hospital Vall d'Hebrón, Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital Universitario Marques de Valdecilla, Santander, , Spain
St. James University Hospital, Leeds, , United Kingdom
Liverpool Cancer Center, Liverpool, , United Kingdom
University College London Hospitals, London, , United Kingdom
The Royal Free Hospital, London, , United Kingdom
The Christie NHS Foundation Trust, the Christie Hospital, Manchester, , United Kingdom
Contact Details
Name: Medical Affairs Servier Pharmaceuticals LLC
Affiliation: Servier Pharmaceuticals, LLC
Role: STUDY_CHAIR
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