Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
Start Date
7/9/2024
Completion Date
11/26/2030
Summary
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Ivosidenib 500mg
Placebo
Conditions
Locations
Usc Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Sarcoma Oncology Research Center
Santa Monica, California 90403
United States
University of Colorado Cancer Center
Aurora, Colorado 80045
United States
Yale Cancer Center
New Haven, Connecticut 06511
United States
Mayo Clinic - Jacksonville, Fl
Jacksonville, Florida 32224
United States
University of Miami
Miami, Florida 33136-1002
United States
Emory Winship Cancer Institute
Atlanta, Georgia 30308
United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611-5975
United States
University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
Johns Hopkins University
Baltimore, Maryland 21287
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Mayo Clinic - Rochester, Mn
Rochester, Minnesota 55905
United States
The Washington University
St Louis, Missouri 63110
United States
Nebraska Methodist Hospital
Omaha, Nebraska 68118
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
Duke University
Durham, North Carolina 27710
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon 97239
United States
University of Pittsburgh Medical Center-Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United States
The Univeristy of Texas Md Anderson Cancer Center
Houston, Texas 77030
United States
Flinders Medical Centre
Bedford Park, 5042
Australia
Chris O'Brien Lifehouse
Camperdown, 2050
Australia
Chris O'Brien Lifehouse
Camperdown, 2050
Australia
St Vincent'S Hospital Melbourne
Fitzroy, 3065
Australia
Sir Charles Gairdner Hospital
Nedlands, 6009
Australia
Princess Alexandra Hospital
Woolloongabba, 4102
Australia
Cliniques Universitaires St. Luc
Brussels, 1200
Belgium
U.Z. Gent
Ghent, 9000
Belgium
Centre Multidisciplinaire de Oncologie Medicale
Liège, 4000
Belgium
Liga Norte Riograndense Contra O Cancer
Natal, Rio Grande do Norte 59062-000
Brazil
Hospital de Amor - Barretos
Barretos, 14784-400
Brazil
Hospital Das Clínicas Da Ufmg
Belo Horizonte, 30130-100
Brazil
CIONC
Curitiba, 80810-050
Brazil
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, 88034-000
Brazil
Fundação Amaral Carvalho - Jaú/ Sp
Jaú, 17210-080
Brazil
Instituto Nacional Do Câncer - Inca
Rio de Janeiro, 20220-410
Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
Brazil
Impar Serviços Hospitalares S.A. - Hospital Nove de Julho
São Paulo, 01409-902
Brazil
Hospital A C Camargo
São Paulo, 01509-010
Brazil
Hospital Albert Einstein
São Paulo, 05652-900
Brazil
Alberta Health Services
Calgary, Alberta T2N-5G2
Canada
University Health Network
Toronto, Ontario M5G 2M9
Canada
Muhc Glen Site
Montreal, Quebec H4A 3J1
Canada
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong 510080
China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430023
China
Shanghai Changzheng Hospital
Shang'ai, Shanghai Municipality 200000
China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality 200025
China
Shanghai General Hospital
Shanghai, Shanghai Municipality 200080
China
West China Hopital of Sichuan University
Chengdu, Sichuan 610041
China
The Second Affiliated Hospital Zhejiang University School of Medical
Hangzhou, Zhejiang 310025
China
Beijing Cancer Hospital
Beijing, 100142
China
Beijing Jishuitan Hospital
Beijing, 102208
China
Henan Cancer Hospital
Guangzhou, 450003
China
Aarhus Universitetshospital
Aarhus, 8200
Denmark
Herlev & Gentofte Hospital
Herlev, 2730
Denmark
Institut Bergonié
Bordeaux, 33076
France
Centre Oscar Lambret
Lille, 59020
France
Hôpital Léon Bérard
Lyon, 69008
France
Hopital de La Timone
Marseille, 13005
France
Hôpital Cochin
Paris, 75014
France
INSTITUT de CANCEROLOGIE de l'Ouest
Saint-Herblain, 44805
France
Iuct-Oncopole Institut Universitaire Du Cancer
Toulouse, 31059
France
Institut Gustave Roussy
Villejuif, 94800
France
Helios Klinikum Bad Saarow
Bad Saarow, 15526
Germany
Charite Universitatsmedizin
Berlin, 13353
Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246
Germany
Universitätsmedizin Mannheim (Umm)
Mannheim, 68167
Germany
Lmu Klinikum
München, 81377
Germany
Ukm - Sarkom-Zentrum
Münster, 48149
Germany
Universitaetsklinikum Ulm
Ulm, 89081
Germany
Irccs Istituto Ortopedico Rizzoli
Bologna, 40136
Italy
Irccs Fondazione Istituto Nazionale Dei Tumori
Milan, 20133
Italy
San Luigi Gonzaga University Hospital of Turin
Orbassano, 10043
Italy
Istituto Oncologico Veneto Iov - Irccs
Padova, 35128
Italy
Aou Policlinico Paolo Giaccone
Palermo, 90127
Italy
Ospedale Santo Stefano
Prato, 59100
Italy
Policlinico Universitario Campus Biomedico
Roma, 00128
Italy
Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
Roma, 00144
Italy
Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken 920-8641
Japan
Nagoya University Hospital
Shōwaku, Nagoya-shi, Aichi 466-8560
Japan
Niigata University Medical and Dental General Hospital
Chūōku, Niigata City 951-8510
Japan
Oita University Hospital
Yufu-Shi, Oita Prefecture 879-5593
Japan
Osaka International Cancer Institute
Chūōku, Osaka-shi, Osaka 700-8558
Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
Japan
Fukushima Medical University Hospital
Fukushima, 960-1295
Japan
Kyushu University Hospital
Higashi, 812-8582
Japan
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, 135-8550
Japan
Okayama University Hospital
Okayama, 700-8558
Japan
Universitair Medisch Centrum Groningen (Umcg)
Groningen, 9713 GZ
Netherlands
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Netherlands
Radboud Umc
Nijmegen, 6525 GA
Netherlands
Pan American Center For Oncology Trials, LLC
Rio Piedras, 00935
Puerto Rico
Seoul National University Hospital
Seoul, 03080
South Korea
Severance Hospital
Seoul, 03722
South Korea
Asan Medical Center
Seoul, 05505
South Korea
Samsung Medical Center
Seoul, 06351
South Korea
Hospital Universitario Valle de Hebrón - Vhio
Barcelona, 08035
Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
Spain
Hospital de Bellvitge - Ico
L'Hospitalet de Llobregat, 08908
Spain
Hospital General Universitario Gregorio
Madrid, 28007
Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario La Paz
Madrid, 28046
Spain
Hospital Universitario Y Politecnico La Fe
Valencia, 46026
Spain
National Taiwan University Hospital
Taipei, 100225
Taiwan
Taipei Veterans General Hospital
Taipei, 112201
Taiwan
Western General Hospital
Edinburgh,
United Kingdom
Royal Marsden Hospital
London,
United Kingdom
UCLH
London,
United Kingdom
Christie Hospital
Manchester, M20 4BX
United Kingdom
Churchill Hospital
Oxford,
United Kingdom