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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.
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
Eligible Ages | 12 Years and Over |
Gender | All |
Key
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT04164901 |
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Institut de Recherches Internationales Servier |
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
Principal Investigator Affiliation | N/A |
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
Overall Status | Active, not recruiting |
Countries | Canada, France, Germany, Israel, Italy, Japan, Netherlands, Spain, Switzerland, United Kingdom, United States |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Grade 2 Glioma, Residual Glioma, Recurrent Glioma |
Experimental: Vorasidenib
Vorasidenib 40 mg, continuous daily dosing.
Placebo Comparator: Matching Placebo
Matching placebo 40 mg, continuous daily dosing.
Drug: - Vorasidenib
Vorasidenib oral film-coated tablets
Drug: - Matching Placebo
Matching Placebo oral tablets
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764, 35294
Status
Address
City of Hope
Duarte 5344147, California 5332921, 91010
Status
Address
University of California San Diego
La Jolla 5363943, California 5332921, 92093
Status
Address
UCLA Oncology Center
Los Angeles 5368361, California 5332921, 90095
Status
Address
University of California Irvine - Hospital
Orange 5379513, California 5332921, 92868
Status
Address
University of California San Francisco
San Francisco 5391959, California 5332921, 94143
Status
Address
Stanford Cancer Center
Stanford 5398563, California 5332921, 94305
Status
Address
University of Colorado Hospital - Anschutz Cancer Pavilion
Aurora 5412347, Colorado 5417618, 80045
Status
Address
Yale University, Yale Cancer Center
New Haven 4839366, Connecticut 4831725, 06510
Status
Address
Mayo Clinic Jacksonville
Jacksonville 4160021, Florida 4155751, 32224
Status
Address
Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics
Miami 4164138, Florida 4155751, 33136
Status
Address
Northwestern University
Chicago 4887398, Illinois 4896861, 60611
Status
Address
University of Chicago
Chicago 4887398, Illinois 4896861, 60637
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Address
Indiana University Medical Center
Indianapolis 4259418, Indiana 4921868, 46202
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Address
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857, 66160
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Address
University of Kentucky
Lexington 4297983, Kentucky 6254925, 40536
Status
Address
Maine Medical Partners Neurology
Scarborough 4977882, Maine 4971068, 04074
Status
Address
John Hopkins Cancer Center
Baltimore 4347778, Maryland 4361885, 21231
Status
Address
Tufts Medical Center
Boston 4930956, Massachusetts 6254926, 02111
Status
Address
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926, 02114
Status
Address
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926, 02215
Status
Address
University of Michigan Comprehensive Cancer Center
Ann Arbor 4984247, Michigan 5001836, 48109
Status
Address
Henry Ford Hospital
Detroit 4990729, Michigan 5001836, 48202
Status
Address
Metro Minnesota Community Oncology
Minneapolis 5037649, Minnesota 5037779, 55416
Status
Address
Mayo Comprehensive Cancer
Rochester 5043473, Minnesota 5037779, 55905
Status
Address
Washington University School of Medicine
St Louis 4407066, Missouri 4398678, 63110
Status
Address
Columbia University Medical Center
New York 5128581, New York 5128638, 10032
Status
Address
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638, 10065
Status
Address
Duke University Medical Center
Durham 4464368, North Carolina 4482348, 27710
Status
Address
Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418, 43210
Status
Address
Oregon Health and Science University
Portland 5746545, Oregon 5744337, 97239
Status
Address
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927, 19104
Status
Address
University of Pittsburgh Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927, 15232
Status
Address
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040, 29425
Status
Address
Tennessee Oncology
Nashville 4644585, Tennessee 4662168, 37203
Status
Address
Baylor University Medical Center
Dallas 4684888, Texas 4736286, 75246
Status
Address
University of Texas Southwestern Medical Center
Dallas 4684888, Texas 4736286, 75390
Status
Address
MD Anderson Cancer Center
Houston 4699066, Texas 4736286, 77030
Status
Address
The University of Utah, Huntsman Cancer Hospital
Salt Lake City 5780993, Utah 5549030, 84112
Status
Address
Seattle Cancer Care Alliance
Seattle 5809844, Washington 5815135, 98109
Status
Address
BC Cancer Agency
Vancouver 6173331, British Columbia 5909050, V5Z 4E6
Status
Address
London Health Sciences Centre
London 6058560, Ontario 6093943, N6A 5W9
Status
Address
Sunnybrook Health Sciences Centre
Toronto 6167865, Ontario 6093943, M4N 3M5
Status
Address
Princess Margaret Hospital
Toronto 6167865, Ontario 6093943,
Status
Address
McGill University Health Center
Montreal 6077243, Quebec 6115047, H3A 2B4
Status
Address
Centre Hospitalier Universitaire de Lille
Lille 2998324, , 59037
Status
Address
Hôpital Pierre Wertheimer
Lyon 2996944, , 69394
Status
Address
Hopitaux de La Timone
Marseille 2995469, , 13385
Status
Address
Hospitalier Pitié Salpétrière
Paris 2988507, , 75013
Status
Address
Universitätsklinikum Essen
Essen 2928810, , 45122
Status
Address
Universitätsklinikum Hamburg Eppendorf
Hamburg 2911298, , 20246
Status
Address
Universitätsklinikum Heidelberg
Heidelberg 2907911, , 69120
Status
Address
Klinikum Mannheim Universitätsklinikum
Mannheim 2873891, , 68135
Status
Address
Hadassah Medical Center
Jerusalem 281184, , 91120
Status
Address
Rabin Medical Center
Petah Tikva 293918, , 49100
Status
Address
Chaim Sheba Medical Center
Ramat Gan 293788, , 52621
Status
Address
Tel Aviv Sourasky Medical Center
Tel Aviv 293397, , 6423906
Status
Address
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Turin 3165524, Piedmont 3170831, 10126
Status
Address
Ospedale Bellaria
Bologna 3181928, , 40139
Status
Address
Istituto Oncologico Veneto - I.R.C.C.S.
Padua 3171728, , 35128
Status
Address
Istituto Nazionale Tumori Regina Elena
Roma 8957247, , 144
Status
Address
Istituto Clinico Humanitas
Rozzano 3168837, , 20089
Status
Address
Nagoya University Hospital
Nagoya 1856057, Aichi-ken 1865694, 466-8560
Status
Address
Fujita Health University Hospital
Toyoake 6822210, Aichi-ken 1865694, 470-1192
Status
Address
Hiroshima University Hospital
Minami-Ku, Hiroshima 1862413, 734-8551
Status
Address
The University of Tokyo Hospital
Bunkyō-Ku, Tokyo 1850144, 113-8655
Status
Address
National Cancer Center Hospital
Chuo Ku, Tokyo 1850144, 104-0045
Status
Address
Kumamoto University Hospital
Kumamoto 1858421, , 860-8556
Status
Address
University Hospital, Kyoto Prefectural University of Medicine
Kyoto 1857910, , 602-8566
Status
Address
Kyoto University Hospital
Kyoto 1857910, , 606-8507
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Address
Okayama University Hospital
Okayama 1854383, , 700-8558
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Address
Haaglanden MC, Antoniushove
Leidschendam 2751769, South Holland 2743698, 2262 BA
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Address
Erasmus Medical Center
Rotterdam 2747891, , 3015 GD
Status
Address
Universitair Medisch Centrum Utrecht
Utrecht 2745912, , 3584 CX
Status
Address
Hospital Universitario Vall d'Hebrón
Barcelona 3128760, , 08035
Status
Address
Hospital Universitario Ramon y Cajal
Madrid 3117735, , 28034
Status
Address
Hospital Universitario 12 de Octubre
Madrid 3117735, , 28041
Status
Address
Hôpitaux Universitaire de Genève
Geneva 2660646, , 1211
Status
Address
Centre Hospitalier Universitaire Vaudois
Lausanne 2659994, , 1011
Status
Address
Universitätsspital Zürich
Zurich 2657896, , 8006
Status
Address
Freeman Hospital
Newcastle upon Tyne 2641673, England 6269131, NE7 7DN
Status
Address
The Royal Marsden NHS Foundation Trust
Sutton 2636503, Surrey, SM2 5PT
Status
Address
Western General Hospital Edinburgh - PPDS
Edinburgh 2650225, , EH4 2XY
Status
Address
The Christie NHS Foundation Trust
Manchester 2643123, , M20 4BX