Phase
Condition
Sarcoma (Pediatric)
Neoplasm Metastasis
Bone Neoplasm
Treatment
Placebo
Ivosidenib 500mg
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have a histopathological diagnosis (fresh or banked tumor biopsy sample collectedwithin the last 3 years) consistent with locally advanced or metastatic conventionalchondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection.
Have at least one BICR-confirmed measurable lesion as defined by RECIST v1.1.Participants who have received prior radiation therapy are eligible providedmeasurable disease falls outside of the treatment field or within the field and hasshown ≥20% growth in size since post-treatment assessment.
Have received 0 or 1 prior systemic treatment regimen in the advanced/metastaticsetting for chondrosarcoma.
Have radiographic progression/recurrence of disease according to RECIST v1.1 definedas:
Radiographic progression of disease (local and/or distant) documented by 2imaging assessments performed no more than 6 months (±2 weeks) apart within 12months before randomization.OR
Any recurrence of disease (local and/or distant) after complete surgicalresection and documented by imaging within 6 months (±2 weeks) beforerandomization.
Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the mostrecent banked tumor tissue available that was sourced from either a primary ormetastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutationvariants tested)
Have recovered from any clinically relevant sequelae and toxic effects of any priorsurgery, radiotherapy, or other therapy intended for the treatment of cancer.
Exclusion
Exclusion Criteria:
Are unable to swallow oral medication.
Pregnant or lactating women.
Are participating in another interventional study at the same time; participation innoninterventional registries or epidemiological studies is allowed.
Have received prior therapy with an IDH1 inhibitor
Have received systemic anticancer therapy <2 weeks prior to randomization (forinvestigational or immune-based anticancer therapy <4 weeks).
Have received radiotherapy <2 weeks prior to randomization.
Have known symptomatic brain metastases requiring steroids >10 mg per day prednisone (or equivalent). Participants with previously diagnosed brain metastases areeligible if they have completed their treatment and have recovered from the acuteeffects of radiation therapy or surgery prior to randomization, have discontinued orreduced corticosteroid treatment <=10 mg per day for these metastases for at least 4weeks and have radiographically stable disease of brain lesions for at least 3months prior to randomization.
Have a history of another primary cancer, with the exception of: a) curativelyresected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c)pT1-2 prostatic cancer Gleason score <6 or d) participant is free of other primarysolid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in theopinion of the Investigator, the disease will not affect participant's outcome inthe setting of current chondrosarcoma diagnosis.
Have had major surgery within 4 weeks prior to randomization.
Have significant active cardiac disease within 6 months prior to randomization,including New York Heart Association (NYHA) Class III or IV congestive heartfailure; myocardial infarction; unstable angina; and/or stroke.
Have LVEF <40% by ECHO scan (or by other methods according to institutionalpractice) obtained within 28 days prior to randomization.
Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome).Participants with a bundle branch block combined with a prolonged QTcF interval maybe permitted based on local cardiology assessment.
Have known medical history of progressive multifocal leukoencephalopathy (PML).
Study Design
Connect with a study center
Flinders Medical Centre
Bedford Park, 5042
AustraliaSite Not Available
Flinders Medical Centre
Bedford Park 2076918, 5042
AustraliaActive - Recruiting
Chris O'Brien Lifehouse
Camperdown, 2050
AustraliaSite Not Available
Chris O'Brien Lifehouse
Camperdown 2172563, 2050
AustraliaSite Not Available
St Vincent'S Hospital Melbourne
Fitzroy, 3065
AustraliaSite Not Available
St Vincent'S Hospital Melbourne
Fitzroy 2166584, 3065
AustraliaActive - Recruiting
Sir Charles Gairdner Hospital
Nedlands, 6009
AustraliaSite Not Available
Sir Charles Gairdner Hospital
Nedlands 2064874, 6009
AustraliaActive - Recruiting
Princess Alexandra Hospital
Woolloongabba, 4102
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba 6943568, 4102
AustraliaActive - Recruiting
Cliniques Universitaires St. Luc
Brussels 2800866, 1200
BelgiumActive - Recruiting
U.Z. Gent
Ghent 2797656, 9000
BelgiumActive - Recruiting
Centre Multidisciplinaire de Oncologie Medicale
Liège 2792413, 4000
BelgiumActive - Recruiting
Liga Norte Riograndense Contra O Cancer
Natal 3394023, Rio Grande do Norte 3390290 59062-000
BrazilActive - Recruiting
Hospital de Amor - Barretos
Barretos, 14784-400
BrazilSite Not Available
Hospital de Amor - Barretos
Barretos 3470451, 14784-400
BrazilActive - Recruiting
Hospital Das Clínicas Da Ufmg
Belo Horizonte, 30130-100
BrazilSite Not Available
Hospital Das Clínicas Da Ufmg
Belo Horizonte 3470127, 30130-100
BrazilActive - Recruiting
CIONC
Curitiba, 80810-050
BrazilSite Not Available
CIONC
Curitiba 3464975, 80810-050
BrazilActive - Recruiting
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, 88034-000
BrazilSite Not Available
Cepon - Centro de Pesquisas Oncologicas
Florianópolis 3463237, 88034-000
BrazilActive - Recruiting
Fundação Amaral Carvalho - Jaú/ Sp
Jaú, 17210-080
BrazilSite Not Available
Fundação Amaral Carvalho - Jaú/ Sp
Jaú 3460005, 17210-080
BrazilActive - Recruiting
Instituto Nacional Do Câncer - Inca
Rio De Janeiro, 20220-410
BrazilSite Not Available
Instituto Nacional Do Câncer - Inca
Rio de Janeiro 3451190, 20220-410
BrazilActive - Recruiting
Hospital A C Camargo
São Paulo, 01509-010
BrazilActive - Recruiting
Hospital Albert Einstein
São Paulo, 05652-900
BrazilActive - Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, 01246-000
BrazilActive - Recruiting
Impar Serviços Hospitalares S.A. - Hospital Nove de Julho
São Paulo, 01409-902
BrazilSite Not Available
Hospital A C Camargo
São Paulo 3448439, 01509-010
BrazilActive - Recruiting
Hospital Albert Einstein
São Paulo 3448439, 05652-900
BrazilActive - Recruiting
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo 3448439, 01246-000
BrazilActive - Recruiting
Impar Serviços Hospitalares S.A. - Hospital Nove de Julho
São Paulo 3448439, 01409-902
BrazilActive - Recruiting
Alberta Health Services
Calgary 5913490, Alberta 5883102 T2N-5G2
CanadaActive - Recruiting
UNIVERSITY HEALTH NETWORK, Princess Margaret Cancer Centre,
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
University Health Network
Toronto, Ontario M5G 2M9
CanadaSite Not Available
Alberta Health Services
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaActive - Recruiting
University Health Network
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaActive - Recruiting
Muhc Glen Site
Montréal, Quebec H4A 3J1
CanadaSite Not Available
Muhc Glen Site
Montreal 6077243, Quebec 6115047 H4A 3J1
CanadaActive - Recruiting
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou 1809858, Guangdong 1809935 510080
ChinaActive - Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei 430023
ChinaSite Not Available
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan 1791247, Hubei 1806949 430023
ChinaActive - Recruiting
Shanghai General Hospital
Shanghai, Shanghai 200080
ChinaSite Not Available
Shanghai Changzheng Hospital
Shang'ai, Shanghai Municipality 1796231 200000
ChinaActive - Recruiting
Shanghai General Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200080
ChinaActive - Recruiting
Shanghai Ruijin Hospital
Shanghai 1796236, Shanghai Municipality 1796231 200025
ChinaActive - Recruiting
West China Hopital of Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
West China Hopital of Sichuan University
Chengdu 1815286, Sichuan 1794299 610041
ChinaActive - Recruiting
The Second Affiliated Hospital Zhejiang University School of Medical
Hangzhou, Zhejiang 310025
ChinaSite Not Available
The Second Affiliated Hospital Zhejiang University School of Medical
Hangzhou 1808926, Zhejiang 1784764 310025
ChinaActive - Recruiting
Beijing Cancer Hospital
Beijing 1816670, 100142
ChinaActive - Recruiting
Beijing Jishuitan Hospital
Beijing 1816670, 102208
ChinaActive - Recruiting
Henan Cancer Hospital
Guangzhou 1809858, 450003
ChinaActive - Recruiting
Aarhus Universitetshospital
Aarhus 2624652, 8200
DenmarkActive - Recruiting
Herlev & Gentofte Hospital
Herlev 2620431, 2730
DenmarkActive - Recruiting
Institut Bergonié
Bordeaux 3031582, 33076
FranceActive - Recruiting
Centre Oscar Lambret
Lille 2998324, 59020
FranceActive - Recruiting
Hôpital Léon Bérard
Lyon 2996944, 69008
FranceActive - Recruiting
Hopital de La Timone
Marseille 2995469, 13005
FranceActive - Recruiting
Hôpital Cochin
Paris 2988507, 75014
FranceActive - Recruiting
INSTITUT de CANCEROLOGIE de l'Ouest
Saint-Herblain 2979590, 44805
FranceActive - Recruiting
Iuct-Oncopole Institut Universitaire Du Cancer
Toulouse 2972315, 31059
FranceActive - Recruiting
Institut Gustave Roussy
Villejuif 2968705, 94800
FranceActive - Recruiting
Helios Klinikum Bad Saarow
Bad Saarow, 15526
GermanySite Not Available
Helios Klinikum Bad Saarow
Bad Saarow 2953366, 15526
GermanyActive - Recruiting
Charite Universitatsmedizin
Berlin, 13353
GermanySite Not Available
Charite Universitatsmedizin
Berlin 2950159, 13353
GermanyActive - Recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanySite Not Available
Universitätsklinikum Carl Gustav Carus Dresden
Dresden 2935022, 01307
GermanyActive - Recruiting
Universitatsklinikum Hamburg-Eppendorf
Hamburg 2911298, 20246
GermanyActive - Recruiting
Universitätsmedizin Mannheim (Umm)
Mannheim, 68167
GermanySite Not Available
Universitätsmedizin Mannheim (Umm)
Mannheim 2873891, 68167
GermanySite Not Available
Lmu Klinikum
Muenchen, 81377
GermanySite Not Available
Lmu Klinikum
München 2867711, 81377
GermanySite Not Available
Ukm - Sarkom-Zentrum
Münster 2867543, 48149
GermanyActive - Recruiting
Universitaetsklinikum Ulm
Ulm 2820256, 89081
GermanyActive - Recruiting
Irccs Istituto Ortopedico Rizzoli
Bologna 3181928, 40136
ItalyActive - Recruiting
Irccs Fondazione Istituto Nazionale Dei Tumori
Milan 6951411, 20133
ItalyActive - Recruiting
San Luigi Gonzaga University Hospital of Turin
Orbassano 3171986, 10043
ItalyActive - Recruiting
Istituto Oncologico Veneto Iov - Irccs
Padua 3171728, 35128
ItalyActive - Recruiting
Aou Policlinico Paolo Giaccone
Palermo, 90127
ItalySite Not Available
Aou Policlinico Paolo Giaccone
Palermo 2523920, 90127
ItalyActive - Recruiting
Ospedale Santo Stefano
Prato, 59100
ItalySite Not Available
Ospedale Santo Stefano
Prato 3169921, 59100
ItalyActive - Recruiting
Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
Roma, 00144
ItalyActive - Recruiting
Policlinico Universitario Campus Biomedico
Roma, 00128
ItalySite Not Available
Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
Roma 8957247, 00144
ItalyActive - Recruiting
Policlinico Universitario Campus Biomedico
Roma 8957247, 00128
ItalyActive - Recruiting
Hokkaido Cancer Center
Sapporo, Hokkaido 003-0804
JapanSite Not Available
Hokkaido Cancer Center
Sapporo 2128295, Hokkaido 2130037 003-0804
JapanActive - Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa 920-8641
JapanSite Not Available
Kanazawa University Hospital
Kanazawa 1860243, Ishikawa-ken 1861387 920-8641
JapanActive - Recruiting
Nagoya University Hospital
Showa-ku, Nagoya-shi, Aichi 466-8560
JapanSite Not Available
Nagoya University Hospital
Shōwaku 10352247, Nagoya-shi, Aichi 466-8560
JapanActive - Recruiting
Niigata University Medical and Dental General Hospital
Chūōku 10262791, Niigata City 951-8510
JapanActive - Recruiting
Oita University Hospital
Yufu, Oita 879-5503
JapanSite Not Available
Oita University Hospital
Yufu-Shi, Oita Prefecture 1854484 879-5593
JapanActive - Recruiting
Osaka International Cancer Institute
Chuo Ku, Osaka-shi, Osaka 700-8558
JapanSite Not Available
Osaka International Cancer Institute
Chūōku 10262791, Osaka-shi, Osaka 700-8558
JapanActive - Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo, 104-0045
JapanActive - Recruiting
Fukushima Medical University Hospital
Fukushima 2112923, 960-1295
JapanActive - Recruiting
Kyushu University Hospital
Higashi, 812-8582
JapanSite Not Available
Kyushu University Hospital
Higashi 1862855, 812-8582
JapanActive - Recruiting
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, 135-8550
JapanActive - Recruiting
Okayama University Hospital
Okayama, 700-8558
JapanSite Not Available
Okayama University Hospital
Okayama 1854383, 700-8558
JapanActive - Recruiting
Cancer Institute Hospital of Jfcr
Tokyo, 135-8550
JapanSite Not Available
Okayama University Hospital
Yufu, 879-5503
JapanActive - Recruiting
Okayama University Hospital
Yufu-shi, 879-5503
JapanActive - Recruiting
Oita University Hospital
Yufu-shi, Oita, 879-5503
JapanSite Not Available
Universitair Medisch Centrum Groningen (Umcg)
Groningen, 9713 GZ
NetherlandsSite Not Available
Universitair Medisch Centrum Groningen (Umcg)
Groningen 2755251, 9713 GZ
NetherlandsActive - Recruiting
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
NetherlandsSite Not Available
Leids Universitair Medisch Centrum
Leiden 2751773, 2333 ZA
NetherlandsActive - Recruiting
Radboud Umc
Nijmegen, 6525 GA
NetherlandsSite Not Available
Radboud Umc
Nijmegen 2750053, 6525 GA
NetherlandsActive - Recruiting
Pan American Center For Oncology Trials, LLC
Rio Piedras 4829037, 00935
Puerto RicoActive - Recruiting
Asan Medical Center
Seoul 1835848, 05505
South KoreaActive - Recruiting
Samsung Medical Center
Seoul 1835848, 06351
South KoreaActive - Recruiting
Seoul National University Hospital
Seoul 1835848, 03080
South KoreaActive - Recruiting
Severance Hospital
Seoul 1835848, 03722
South KoreaActive - Recruiting
Hospital Universitario Valle de Hebrón - Vhio
Barcelona, 08035
SpainSite Not Available
Hospital de La Santa Creu I Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital Universitario Valle de Hebrón - Vhio
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital de La Santa Creu I Sant Pau
Barcelona 3128760, 08041
SpainActive - Recruiting
Hospital de Bellvitge - Ico
L'Hospitalet De Llobregat, 08908
SpainSite Not Available
Hospital de Bellvitge - Ico
L'Hospitalet de Llobregat 3120619, 08908
SpainActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid, 28040
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Hospital General Universitario Gregorio
Madrid 3117735, 28007
SpainActive - Recruiting
Hospital Universitario Fundación Jiménez Díaz
Madrid 3117735, 28040
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid 3117735, 28046
SpainActive - Recruiting
Hospital Universitario Y Politecnico La Fe
Valencia, 46026
SpainSite Not Available
Hospital Universitario Y Politecnico La Fe
Valencia 2509954, 46026
SpainActive - Recruiting
National Taiwan University Hospital
Taipei, 100225
TaiwanSite Not Available
National Taiwan University Hospital
Taipei 1668341, 100225
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei 1668341, 112201
TaiwanActive - Recruiting
Western General Hospital
Edinburgh,
United KingdomSite Not Available
Western General Hospital
Edinburgh 2650225,
United KingdomActive - Recruiting
Royal Marsden Hospital
London,
United KingdomActive - Recruiting
UCLH
London,
United KingdomSite Not Available
Royal Marsden Hospital
London 2643743,
United KingdomActive - Recruiting
UCLH
London 2643743,
United KingdomActive - Recruiting
Christie Hospital
Manchester, M20 4BX
United KingdomSite Not Available
Christie Hospital
Manchester 2643123, M20 4BX
United KingdomActive - Recruiting
Churchill Hospital
Oxford,
United KingdomSite Not Available
Churchill Hospital
Oxford 2640729,
United KingdomActive - Recruiting
Usc Norris Comprehensive Cancer Center
Los Angeles, California 90033
United StatesSite Not Available
Sarcoma Oncology Research Center
Santa Monica, California 90403
United StatesSite Not Available
Usc Norris Comprehensive Cancer Center
Los Angeles 5368361, California 5332921 90033
United StatesActive - Recruiting
Sarcoma Oncology Research Center
Santa Monica 5393212, California 5332921 90403
United StatesActive - Recruiting
University of Colorado Cancer Center
Aurora, Colorado 80045
United StatesSite Not Available
University of Colorado Cancer Center
Aurora 5412347, Colorado 5417618 80045
United StatesActive - Recruiting
Yale Cancer Center
New Haven, Connecticut 06511
United StatesSite Not Available
Yale Cancer Center
New Haven 4839366, Connecticut 4831725 06511
United StatesActive - Recruiting
Mayo Clinic - Jacksonville, Fl
Jacksonville, Florida 32224
United StatesSite Not Available
University of Miami
Miami, Florida 33136-1002
United StatesSite Not Available
Mayo Clinic - Jacksonville, Fl
Jacksonville 4160021, Florida 4155751 32224
United StatesActive - Recruiting
University of Miami
Miami 4164138, Florida 4155751 33136-1002
United StatesActive - Recruiting
Emory Winship Cancer Institute
Atlanta, Georgia 30308
United StatesSite Not Available
Emory Winship Cancer Institute
Atlanta 4180439, Georgia 4197000 30308
United StatesActive - Recruiting
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois 60611-5975
United StatesSite Not Available
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago 4887398, Illinois 4896861 60611-5975
United StatesActive - Recruiting
University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United StatesSite Not Available
University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
Iowa City 4862034, Iowa 4862182 52242
United StatesActive - Recruiting
Johns Hopkins University
Baltimore 4347778, Maryland 4361885 21287
United StatesActive - Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United StatesSite Not Available
Dana-Farber Cancer Institute
Boston 4930956, Massachusetts 6254926 02215
United StatesActive - Recruiting
Mayo Clinic - Rochester, Mn
Rochester, Minnesota 55905
United StatesSite Not Available
Mayo Clinic - Rochester, Mn
Rochester 5043473, Minnesota 5037779 55905
United StatesActive - Recruiting
The Washington University
Saint Louis, Missouri 63110
United StatesSite Not Available
The Washington University
St Louis 4407066, Missouri 4398678 63110
United StatesActive - Recruiting
Nebraska Methodist Hospital
Omaha, Nebraska 68118
United StatesSite Not Available
Nebraska Methodist Hospital
Omaha 5074472, Nebraska 5073708 68118
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York 5128581, New York 5128638 10065
United StatesActive - Recruiting
Duke University
Durham, North Carolina 27710
United StatesSite Not Available
Usc Norris Comprehensive Cancer Center
Durham, North Carolina 27710
United StatesActive - Recruiting
Duke University
Durham 4464368, North Carolina 4482348 27710
United StatesActive - Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
United StatesSite Not Available
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesSite Not Available
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
United StatesActive - Recruiting
The Ohio State University Comprehensive Cancer Center
Columbus 4509177, Ohio 5165418 43210
United StatesActive - Recruiting
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon 97239
United StatesSite Not Available
Oregon Health & Science University Knight Cancer Institute
Portland 5746545, Oregon 5744337 97239
United StatesActive - Recruiting
University of Pittsburgh Medical Center-Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United StatesSite Not Available
University of Pittsburgh Medical Center-Hillman Cancer Center
Pittsburgh 5206379, Pennsylvania 6254927 15232
United StatesActive - Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
United StatesActive - Recruiting
The Univeristy of Texas Md Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
The Univeristy of Texas Md Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting

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