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Spots Global Cancer Trial Database for A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

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Trial Identification

Brief Title: A Trial to Evaluate Multiple Regimens in Newly Diagnosed and Recurrent Glioblastoma

Official Title: GBM AGILE: Global Adaptive Trial Master Protocol: An International, Seamless Phase II/III Response Adaptive Randomization Platform Trial Designed To Evaluate Multiple Regimens In Newly Diagnosed and Recurrent GBM

Study ID: NCT03970447

Conditions

Glioblastoma

Study Description

Brief Summary: Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM.

Detailed Description: Glioblastoma (GBM) adaptive, global, innovative learning environment (GBM AGILE) is an international, seamless Phase II/III response adaptive randomization platform trial designed to evaluate multiple therapies in newly diagnosed (ND) and recurrent GBM. Its goals are to identify effective therapies for glioblastoma and match effective therapies with patient subtypes. Bayesian response adaptive randomization is used within subtypes of the disease to assign participants to Arms based on their performance. The primary endpoint is overall survival (OS). GBM AGILE is designed to efficiently evaluate therapies. The trial will be conducted under a single Master Investigational New Drug Application/Clinical Trial Application and Master Protocol, allowing multiple drugs and drug combinations from different pharmaceutical companies to be evaluated simultaneously. The plan is to add experimental therapies as new information about promising new drugs are identified and remove therapies as they complete their evaluation.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of Alabama at Birmingham, Birmingham, Alabama, United States

University of California, San Diego, La Jolla, California, United States

Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States

University of California, Los Angeles, Los Angeles, California, United States

St. Joseph 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 Denver, Aurora, Colorado, United States

Yale Cancer Center / Smilow Cancer Hospital, New Haven, Connecticut, United States

Mayo Clinic Cancer Center, Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center, Miami, Florida, United States

Moffitt Cancer Center, Tampa, Florida, United States

Piedmont Atlanta Hospital, Atlanta, Georgia, United States

Winship Cancer Institute of Emory University, Atlanta, Georgia, United States

LSU Health Sciences Center - New Orleans, New Orleans, Louisiana, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Dana Farber Cancer Institute, Boston, Massachusetts, United States

Henry Ford Health System, Detroit, Michigan, United States

Abbott Northwestern Hospital, Minneapolis, Minnesota, United States

Mayo Clinic Cancer Center - Rochester, Rochester, Minnesota, United States

University of Mississippi Medical Center, Jackson, Mississippi, United States

Washington University School of Medicine - Siteman Cancer Center, Saint Louis, Missouri, United States

Perlmutter Cancer Center, NYU Langone Health, New York, New York, United States

Icahn School of Medicine at Mount Sinai, New York, New York, 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

Comprehensive Cancer Center of Wake Forest, Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States

Cleveland Clinic, Cleveland, Ohio, United States

Ohio State University Cancer Center, Columbus, Ohio, United States

University of Pennsylvania - Perelman Center for Advanced Medicine, Philadelphia, Pennsylvania, United States

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States

University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

Medical University of South Carolina - Hollings Cancer Center, Charleston, South Carolina, United States

Texas Oncology - Austin, Austin, Texas, United States

University of Texas Southwestern Medical Center, Dallas, Texas, United States

University of Texas - MD Anderson Cancer Center, Houston, Texas, United States

University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States

University of Virginia Health, Charlottesville, Virginia, United States

University of Washington Medical Center, Seattle, Washington, United States

Froedtert Hospital/Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Northern Sydney Cancer Centre/Royal North Shore Hospital, St Leonards, New South Wales, Australia

Calvary Mater Newcastle, Waratah, New South Wales, Australia

Austin Health, Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

Princess Margaret Cancer Centre, Toronto, Ontario, Canada

Montreal Neurological Institute and Hospital, McGill University, Montréal, Quebec, Canada

Université de Sherbrooke, Sherbrooke, Quebec, Canada

Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer, Bron, , France

Hopital de la Timone, Marseille, , France

Hopital Piti-Salpetriere, Paris, , France

Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie, Cologne, , Germany

Dr. Senckenbergisches Institut für Neuroonkologie, Frankfurt, , Germany

Universitätsklinik Heidelberg, Heidelberg, , Germany

Universitätsklinikum Regensburg, Regensburg, , Germany

Universitätsklinikum Tübingen, Tübingen, , Germany

Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne, Vaud, Switzerland

Universitätsspital Basel, Basel, , Switzerland

University Hospital Zurich, Zürich, , Switzerland

Contact Details

Name: Tim Cloughesy, MD

Affiliation: GCAR CMO and GBM AGILE Global PI

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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