Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

331

Participants

Timeline

Start Date

January 5, 2020

Primary Completion Date

September 6, 2022

Study Completion Date

May 31, 2028

Conditions
Grade 2 GliomaResidual GliomaRecurrent Glioma
Interventions
DRUG

Vorasidenib

Vorasidenib oral film-coated tablets

DRUG

Matching Placebo

Matching Placebo oral tablets

Trial Locations (84)

144

Istituto Nazionale Tumori Regina Elena, Roma

1011

Centre Hospitalier Universitaire Vaudois, Lausanne

1211

Hôpitaux Universitaire de Genève, Geneva

8006

Universitätsspital Zürich, Zurich

10032

Columbia University Medical Center, New York

10065

Memorial Sloan Kettering Cancer Center, New York

10126

Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin

13385

Hopitaux de La Timone, Marseille

15232

University of Pittsburgh Hillman Cancer Center, Pittsburgh

19104

University of Pennsylvania, Philadelphia

20089

Istituto Clinico Humanitas, Rozzano

20246

Universitätsklinikum Hamburg Eppendorf, Hamburg

21231

John Hopkins Cancer Center, Baltimore

27710

Duke University Medical Center, Durham

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

29425

Medical University of South Carolina, Charleston

32224

Mayo Clinic Jacksonville, Jacksonville

33136

Sylvester Comprehensive Cancer Center - University of Miami Hospital and Clinics, Miami

35128

Istituto Oncologico Veneto - I.R.C.C.S., Padua

35294

University of Alabama at Birmingham, Birmingham

37203

Tennessee Oncology, Nashville

40139

Ospedale Bellaria, Bologna

40536

University of Kentucky, Lexington

43210

Ohio State University Comprehensive Cancer Center, Columbus

45122

Universitätsklinikum Essen, Essen

46202

Indiana University Medical Center, Indianapolis

48109

University of Michigan Comprehensive Cancer Center, Ann Arbor

48202

Henry Ford Hospital, Detroit

49100

Rabin Medical Center, Petah Tikva

52621

Chaim Sheba Medical Center, Ramat Gan

55416

Metro Minnesota Community Oncology, Minneapolis

55905

Mayo Comprehensive Cancer, Rochester

59037

Centre Hospitalier Universitaire de Lille, Lille

60611

Northwestern University, Chicago

60637

University of Chicago, Chicago

63110

Washington University School of Medicine, St Louis

66160

University of Kansas Medical Center, Kansas City

68135

Klinikum Mannheim Universitätsklinikum, Mannheim

69120

Universitätsklinikum Heidelberg, Heidelberg

69394

Hôpital Pierre Wertheimer, Lyon

75013

Hospitalier Pitié Salpétrière, Paris

75246

Baylor University Medical Center, Dallas

75390

University of Texas Southwestern Medical Center, Dallas

77030

MD Anderson Cancer Center, Houston

80045

University of Colorado Hospital - Anschutz Cancer Pavilion, Aurora

84112

The University of Utah, Huntsman Cancer Hospital, Salt Lake City

90095

UCLA Oncology Center, Los Angeles

91010

City of Hope, Duarte

91120

Hadassah Medical Center, Jerusalem

92093

University of California San Diego, La Jolla

92868

University of California Irvine - Hospital, Orange

94143

University of California San Francisco, San Francisco

94305

Stanford Cancer Center, Stanford

97239

Oregon Health and Science University, Portland

98109

Seattle Cancer Care Alliance, Seattle

6423906

Tel Aviv Sourasky Medical Center, Tel Aviv

06510

Yale University, Yale Cancer Center, New Haven

04074

Maine Medical Partners Neurology, Scarborough

02111

Tufts Medical Center, Boston

02114

Massachusetts General Hospital, Boston

02215

Dana-Farber Cancer Institute, Boston

V5Z 4E6

BC Cancer Agency, Vancouver

N6A 5W9

London Health Sciences Centre, London

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

Unknown

Princess Margaret Hospital, Toronto

H3A 2B4

McGill University Health Center, Montreal

466-8560

Nagoya University Hospital, Nagoya

470-1192

Fujita Health University Hospital, Toyoake

734-8551

Hiroshima University Hospital, Minami-Ku

113-8655

The University of Tokyo Hospital, Bunkyō-Ku

104-0045

National Cancer Center Hospital, Chuo Ku

860-8556

Kumamoto University Hospital, Kumamoto

602-8566

University Hospital, Kyoto Prefectural University of Medicine, Kyoto

606-8507

Kyoto University Hospital, Kyoto

700-8558

Okayama University Hospital, Okayama

2262 BA

Haaglanden MC, Antoniushove, Leidschendam

3015 GD

Erasmus Medical Center, Rotterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

08035

Hospital Universitario Vall d'Hebrón, Barcelona

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

EH4 2XY

Western General Hospital Edinburgh - PPDS, Edinburgh

M20 4BX

The Christie NHS Foundation Trust, Manchester

All Listed Sponsors
lead

Institut de Recherches Internationales Servier

OTHER