1,280
Participants
Start Date
July 30, 2019
Primary Completion Date
June 30, 2028
Study Completion Date
June 30, 2030
Temozolomide
Dosage Form: Capsule for oral administration Strengths: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg
Lomustine
Dosage Form: Capsule for oral administration Strength: 5 mg, 10 mg, 40 mg, and 100 mg
Regorafenib
Dosage Form: Tablet for oral administration Strength: 40 mg Standard Regimen: 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
Radiation
60 Gy
Paxalisib
Dosage Form: Tablet for oral administration Strength: 15 mg Standard Regimen: 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles
VAL-083
Dosage Form: Infusion for intravenous administration Strength: 40 mg per vial Standard Regimen: 30 mg/m2 on Day 1, 2 and 3 of 21-day cycle. The drug is available in powder form. It is reconstituted with 5 mL of 0.9% Sodium Chloride for Injection, USP. This will produce a solution of 40 mg VAL-083 in 5 mL. The required volume of reconstituted VAL-083 for the patient is then calculated at the rate of 30 mg/m2. The corresponding volume is further diluted into 250 mL of 0.9% Sodium Chloride for Injection, USP, prior to intravenous administration.
VT1021
"Dosage Form: Infusion for intravenous administration Strength: 10 mg/mL Standard Regimen Newly Diagnosed: Dose as confirmed through the dose finding phase, administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri).~Standard Regimen Recurrent: 12 mg/kg administered twice weekly (Mon and Thurs or Tues and Fri or Mon and Fri). The drug is available as a sterile solution of the acetate salt formulated with phosphate-buffered saline, mannitol, and 2.5% polysorbate 80. The required volume stock solution for the patient is calculated. The corresponding volume is diluted in 500 mL of either 0.9% saline or D5W, prior to intravenous administration."
Troriluzole
Dosage Form: Capsule for oral administration Strength: 100 mg Standard Regimen: Dose as confirmed through the dose finding phase orally BID.
ADI-PEG 20
Dosage Form: Solution for intramuscular injection Strength: 11.5 ± 1.0 mg/ml Standard Regimen: For newly diagnosed patients, 36mg/m2. For recurrent disease patients, dose as confirmed through the dose finding phase intramuscularly once a week
AZD1390
Standard Regimen Newly Diagnosed: Given once daily on days of radiation and once daily for 14 consecutive days after completion of radiation.
ACTIVE_NOT_RECRUITING
Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne
RECRUITING
Northern Sydney Cancer Centre/Royal North Shore Hospital, St Leonards
RECRUITING
Calvary Mater Newcastle, Waratah
RECRUITING
Austin Health, Heidelberg
RECRUITING
Royal Brisbane and Women's Hospital, Herston
RECRUITING
Flinders Medical Centre, Bedford Park
RECRUITING
Perlmutter Cancer Center, NYU Langone Health, New York
RECRUITING
Icahn School of Medicine at Mount Sinai, New York
RECRUITING
Columbia University Medical Center, New York
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
ACTIVE_NOT_RECRUITING
Hopital de la Timone, Marseille
ACTIVE_NOT_RECRUITING
Allegheny General Hospital, Pittsburgh
RECRUITING
University of Pittsburgh Medical Center - Hillman Cancer Center, Pittsburgh
RECRUITING
University of Pennsylvania - Perelman Center for Advanced Medicine, Philadelphia
RECRUITING
University of Virginia Health, Charlottesville
RECRUITING
Duke University Medical Center, Durham
RECRUITING
Medical University of South Carolina - Hollings Cancer Center, Charleston
RECRUITING
Piedmont Atlanta Hospital, Atlanta
COMPLETED
Winship Cancer Institute of Emory University, Atlanta
COMPLETED
Mayo Clinic Cancer Center, Jacksonville
RECRUITING
Sylvester Comprehensive Cancer Center, Miami
RECRUITING
Moffitt Cancer Center, Tampa
RECRUITING
University of Alabama at Birmingham, Birmingham
COMPLETED
University of Mississippi Medical Center, Jackson
RECRUITING
Ohio State University Cancer Center, Columbus
RECRUITING
University Hospitals Cleveland Medical Center, Cleveland
RECRUITING
Cleveland Clinic, Cleveland
ACTIVE_NOT_RECRUITING
Henry Ford Health System, Detroit
ACTIVE_NOT_RECRUITING
Uniklinik Koeln - Zentrum fuer Neurologie und Psychiatrie, Cologne
ACTIVE_NOT_RECRUITING
Froedtert Hospital/Medical College of Wisconsin, Milwaukee
RECRUITING
Abbott Northwestern Hospital, Minneapolis
COMPLETED
Mayo Clinic Cancer Center - Rochester, Rochester
ACTIVE_NOT_RECRUITING
Dr. Senckenbergisches Institut für Neuroonkologie, Frankfurt
COMPLETED
Washington University School of Medicine - Siteman Cancer Center, St Louis
ACTIVE_NOT_RECRUITING
Universitätsklinik Heidelberg, Heidelberg
ACTIVE_NOT_RECRUITING
Centre Hospitalier Lyon Sud / Hôpital Neurologique P. Wertheimer, Bron
ACTIVE_NOT_RECRUITING
LSU Health Sciences Center - New Orleans, New Orleans
ACTIVE_NOT_RECRUITING
Universitätsklinikum Tübingen, Tübingen
ACTIVE_NOT_RECRUITING
Hopital Piti-Salpetriere, Paris
RECRUITING
University of Texas Southwestern Medical Center, Dallas
RECRUITING
University of Texas - MD Anderson Cancer Center, Houston
ACTIVE_NOT_RECRUITING
Texas Oncology - Austin, Austin
RECRUITING
University of Colorado Denver, Aurora
RECRUITING
University of Utah - Huntsman Cancer Institute, Salt Lake City
RECRUITING
Cedars Sinai - Samuel Oschin Comprehensive Cancer Institute, Los Angeles
RECRUITING
University of California, Los Angeles, Los Angeles
RECRUITING
University of California, San Diego, La Jolla
RECRUITING
St. Joseph Hospital, Orange
ACTIVE_NOT_RECRUITING
Universitätsklinikum Regensburg, Regensburg
RECRUITING
University of California, San Francisco, San Francisco
COMPLETED
Stanford Cancer Center, Stanford
ACTIVE_NOT_RECRUITING
University of Washington Medical Center, Seattle
RECRUITING
Comprehensive Cancer Center of Wake Forest, Winston-Salem
RECRUITING
Yale Cancer Center / Smilow Cancer Hospital, New Haven
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
Dana Farber Cancer Institute, Boston
RECRUITING
Peter MacCallum Cancer Centre, Melbourne
ACTIVE_NOT_RECRUITING
University Hospital Zurich, Zurich
RECRUITING
Sunnybrook Health Sciences Centre, Toronto
ACTIVE_NOT_RECRUITING
Princess Margaret Cancer Centre, Toronto
RECRUITING
Montreal Neurological Institute and Hospital, McGill University, Montreal
ACTIVE_NOT_RECRUITING
Université de Sherbrooke, Sherbrooke
Bayer
INDUSTRY
Kazia Therapeutics Limited
INDUSTRY
Kintara Therapeutics, Inc.
INDUSTRY
Biohaven Pharmaceuticals, Inc.
INDUSTRY
Vigeo Therapeutics, Inc.
INDUSTRY
Polaris Group
INDUSTRY
AstraZeneca
INDUSTRY
Global Coalition for Adaptive Research
OTHER