Spots Global Cancer Trial Database for Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
Official Title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-Controlled Study of AG-881 in Subjects With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation
Study ID: NCT04164901
Study Description
Brief Summary: Study AG881-C-004 is a phase 3, multicenter, randomized, double-blind, placebo-controlled study comparing the efficacy of vorasidenib to placebo in participants with residual or recurrent Grade 2 glioma with an IDH1 or IDH2 mutation who have undergone surgery as their only treatment. Participants will be required to have central confirmation of IDH mutation status prior to randomization. Approximately 340 participants are planned to be randomized 1:1 to receive orally administered vorasidenib 40 mg QD or placebo.
Detailed Description:
Keywords
Eligibility
Minimum Age: 12 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope, Duarte, California, United States
University of California San Diego, La Jolla, California, United States
UCLA Oncology Center, Los Angeles, California, United States
University of California Irvine - Hospital, Orange, California, United States
University of California San Francisco, San Francisco, California, United States
Stanford Cancer Center, Stanford, California, United States
University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora, Colorado, United States
Yale University, Yale Cancer Center, New Haven, Connecticut, United States
Mayo Clinic Jacksonville, Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics, Miami, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Chicago, Chicago, Illinois, United States
Indiana University Medical Center, Indianapolis, Indiana, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
University of Kentucky, Lexington, Kentucky, United States
Maine Medical Partners Neurology, Scarborough, Maine, United States
John Hopkins Cancer Center, Baltimore, Maryland, United States
Tufts Medical Center, Boston, Massachusetts, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
Henry Ford Hospital, Detroit, Michigan, United States
Metro Minnesota Community Oncology, Minneapolis, Minnesota, United States
Mayo Comprehensive Cancer, Rochester, Minnesota, United States
Washington University School of Medicine, Saint Louis, Missouri, United States
Columbia University Medical Center, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Pennsylvania, Philadelphia, Pennsylvania, United States
University of Pittsburgh Hillman Cancer Center, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
Tennessee Oncology, Nashville, Tennessee, United States
Baylor University Medical Center, Dallas, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
The University of Utah, Huntsman Cancer Hospital, Salt Lake City, Utah, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
BC Cancer Agency, Vancouver, British Columbia, Canada
London Health Sciences Centre, London, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
McGill University Health Center, Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Lille, Lille, , France
Hôpital Pierre Wertheimer, Lyon, , France
Hopitaux de La Timone, Marseille, , France
Hospitalier Pitié Salpétrière, Paris, , France
Universitätsklinikum Essen, Essen, , Germany
Universitätsklinikum Hamburg Eppendorf, Hamburg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Klinikum Mannheim Universitätsklinikum, Mannheim, , Germany
Hadassah Medical Center, Jerusalem, , Israel
Rabin Medical Center, Petah Tikva, , Israel
Chaim Sheba Medical Center, Ramat-Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Azienda Ospedaliera Città della Salute e della Scienza di Torino, Torino, Piemonte, Italy
Ospedale Bellaria, Bologna, , Italy
Istituto Oncologico Veneto - I.R.C.C.S., Padua, , Italy
Istituto Nazionale Tumori Regina Elena, Roma, , Italy
Istituto Clinico Humanitas, Rozzano, , Italy
Nagoya University Hospital, Nagoya, Aichi, Japan
Fujita Health University Hospital, Toyoake, Aichi, Japan
Hiroshima University Hospital, Minami-Ku, Hiroshima, Japan
The University of Tokyo Hospital, Bunkyō-Ku, Tokyo, Japan
National Cancer Center Hospital, Chuo Ku, Tokyo, Japan
Kumamoto University Hospital, Kumamoto, , Japan
University Hospital, Kyoto Prefectural University of Medicine, Kyoto, , Japan
Kyoto University Hospital, Kyoto, , Japan
Okayama University Hospital, Okayama, , Japan
Haaglanden MC, Antoniushove, Leidschendam, Zuid-Holland, Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Universitair Medisch Centrum Utrecht, Utrecht, , Netherlands
Hospital Universitario Vall d'Hebrón, Barcelona, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hôpitaux Universitaire de Genève, Geneva, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Universitätsspital Zürich, Zürich, , Switzerland
Freeman Hospital, Newcastle Upon Tyne, England, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Western General Hospital Edinburgh - PPDS, Edinburgh, , United Kingdom
The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
