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Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen

Sponsor: Servier Bio-Innovation LLC · NCT06127407 on ClinicalTrials.gov ↗

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Conditions studied

Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen

What it tests

  • Ivosidenib 500mgdrug
  • Placebodrug

Where it's running114 sites

  • Usc Norris Comprehensive Cancer Center

    Los Angeles, California 90033

    Recruiting now

  • Sarcoma Oncology Research Center

    Santa Monica, California 90403

    Recruiting now

  • University of Colorado Cancer Center

    Aurora, Colorado 80045

    Recruiting now

  • Yale Cancer Center

    New Haven, Connecticut 06511

    Recruiting now

  • Mayo Clinic - Jacksonville, Fl

    Jacksonville, Florida 32224

    Recruiting now

  • University of Miami

    Miami, Florida 33136-1002

    Recruiting now

  • Emory Winship Cancer Institute

    Atlanta, Georgia 30308

    Recruiting now

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    Chicago, Illinois 60611-5975

    Recruiting now

  • University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center

    Iowa City, Iowa 52242

    Recruiting now

  • Johns Hopkins University

    Baltimore, Maryland 21287

    Recruiting now

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215

    Recruiting now

  • Mayo Clinic - Rochester, Mn

    Rochester, Minnesota 55905

    Recruiting now

  • The Washington University

    St Louis, Missouri 63110

    Recruiting now

  • Nebraska Methodist Hospital

    Omaha, Nebraska 68118

    Recruiting now

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065

    Recruiting now

  • Duke University

    Durham, North Carolina 27710

    Recruiting now

  • Cleveland Clinic

    Cleveland, Ohio 44195

    Recruiting now

  • The Ohio State University Comprehensive Cancer Center

    Columbus, Ohio 43210

    Recruiting now

  • Oregon Health & Science University Knight Cancer Institute

    Portland, Oregon 97239

    Recruiting now

  • University of Pittsburgh Medical Center-Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232

    Recruiting now

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232

    Recruiting now

  • The Univeristy of Texas Md Anderson Cancer Center

    Houston, Texas 77030

    Recruiting now
92 international sites

  • Flinders Medical Centre

    Bedford Park, Australia 5042

    Recruiting now

  • Chris O'Brien Lifehouse

    Camperdown, Australia 2050

    Opening soon

  • Chris O'Brien Lifehouse

    Camperdown, Australia 2050

    Recruiting now

  • St Vincent'S Hospital Melbourne

    Fitzroy, Australia 3065

    Recruiting now

  • Sir Charles Gairdner Hospital

    Nedlands, Australia 6009

    Recruiting now

  • Princess Alexandra Hospital

    Woolloongabba, Australia 4102

    Recruiting now

  • Cliniques Universitaires St. Luc

    Brussels, Belgium 1200

    Recruiting now

  • U.Z. Gent

    Ghent, Belgium 9000

    Recruiting now

  • Centre Multidisciplinaire de Oncologie Medicale

    Liège, Belgium 4000

    Recruiting now

  • Liga Norte Riograndense Contra O Cancer

    Natal, Rio Grande do Norte, Brazil 59062-000

    Recruiting now

  • Hospital de Amor - Barretos

    Barretos, Brazil 14784-400

    Recruiting now

  • Hospital Das Clínicas Da Ufmg

    Belo Horizonte, Brazil 30130-100

    Recruiting now

  • CIONC

    Curitiba, Brazil 80810-050

    Recruiting now

  • Cepon - Centro de Pesquisas Oncologicas

    Florianópolis, Brazil 88034-000

    Recruiting now

  • Fundação Amaral Carvalho - Jaú/ Sp

    Jaú, Brazil 17210-080

    Recruiting now

  • Instituto Nacional Do Câncer - Inca

    Rio de Janeiro, Brazil 20220-410

    Recruiting now

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    São Paulo, Brazil 01246-000

    Recruiting now

  • Impar Serviços Hospitalares S.A. - Hospital Nove de Julho

    São Paulo, Brazil 01409-902

    Recruiting now

  • Hospital A C Camargo

    São Paulo, Brazil 01509-010

    Recruiting now

  • Hospital Albert Einstein

    São Paulo, Brazil 05652-900

    Recruiting now

  • Alberta Health Services

    Calgary, Alberta, Canada T2N-5G2

    Recruiting now

  • University Health Network

    Toronto, Ontario, Canada M5G 2M9

    Recruiting now
    • (contact)4165964200
    • ABDULAZEEZ SALAWU, MD(principal investigator)

  • Muhc Glen Site

    Montreal, Quebec, Canada H4A 3J1

    Recruiting now

  • The First Affiliated Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong, China 510080

    Recruiting now

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, China 430023

    Recruiting now

  • Shanghai Changzheng Hospital

    Shang'ai, Shanghai Municipality, China 200000

    Recruiting now

  • Shanghai Ruijin Hospital

    Shanghai, Shanghai Municipality, China 200025

    Recruiting now

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, China 200080

    Recruiting now

  • West China Hopital of Sichuan University

    Chengdu, Sichuan, China 610041

    Recruiting now

  • The Second Affiliated Hospital Zhejiang University School of Medical

    Hangzhou, Zhejiang, China 310025

    Recruiting now

  • Beijing Cancer Hospital

    Beijing, China 100142

    Recruiting now

  • Beijing Jishuitan Hospital

    Beijing, China 102208

    Recruiting now

  • Henan Cancer Hospital

    Guangzhou, China 450003

    Recruiting now

  • Aarhus Universitetshospital

    Aarhus, Denmark 8200

    Recruiting now

  • Herlev & Gentofte Hospital

    Herlev, Denmark 2730

    Recruiting now

  • Institut Bergonié

    Bordeaux, France 33076

    Recruiting now

  • Centre Oscar Lambret

    Lille, France 59020

    Recruiting now

  • Hôpital Léon Bérard

    Lyon, France 69008

    Recruiting now

  • Hopital de La Timone

    Marseille, France 13005

    Recruiting now

  • Hôpital Cochin

    Paris, France 75014

    Recruiting now

  • INSTITUT de CANCEROLOGIE de l'Ouest

    Saint-Herblain, France 44805

    Recruiting now

  • Iuct-Oncopole Institut Universitaire Du Cancer

    Toulouse, France 31059

    Recruiting now

  • Institut Gustave Roussy

    Villejuif, France 94800

    Recruiting now

  • Helios Klinikum Bad Saarow

    Bad Saarow, Germany 15526

    Recruiting now

  • Charite Universitatsmedizin

    Berlin, Germany 13353

    Recruiting now

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, Germany 01307

    Recruiting now

  • Universitatsklinikum Hamburg-Eppendorf

    Hamburg, Germany 20246

    Recruiting now

  • Universitätsmedizin Mannheim (Umm)

    Mannheim, Germany 68167

    Recruiting now

  • Lmu Klinikum

    München, Germany 81377

    Recruiting now

  • Ukm - Sarkom-Zentrum

    Münster, Germany 48149

    Recruiting now

  • Universitaetsklinikum Ulm

    Ulm, Germany 89081

    Recruiting now

  • Irccs Istituto Ortopedico Rizzoli

    Bologna, Italy 40136

    Recruiting now

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    Milan, Italy 20133

    Recruiting now

  • San Luigi Gonzaga University Hospital of Turin

    Orbassano, Italy 10043

    Recruiting now

  • Istituto Oncologico Veneto Iov - Irccs

    Padova, Italy 35128

    Recruiting now

  • Aou Policlinico Paolo Giaccone

    Palermo, Italy 90127

    Recruiting now

  • Ospedale Santo Stefano

    Prato, Italy 59100

    Recruiting now

  • Policlinico Universitario Campus Biomedico

    Roma, Italy 00128

    Recruiting now

  • Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)

    Roma, Italy 00144

    Recruiting now

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, Japan 003-0804

    Recruiting now

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, Japan 920-8641

    Recruiting now

  • Nagoya University Hospital

    Shōwaku, Nagoya-shi, Aichi, Japan 466-8560

    Recruiting now

  • Niigata University Medical and Dental General Hospital

    Chūōku, Niigata City, Japan 951-8510

    Recruiting now

  • Oita University Hospital

    Yufu-Shi, Oita Prefecture, Japan 879-5593

    Recruiting now

  • Osaka International Cancer Institute

    Chūōku, Osaka-shi, Osaka, Japan 700-8558

    Recruiting now

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, Japan 104-0045

    Recruiting now

  • Fukushima Medical University Hospital

    Fukushima, Japan 960-1295

    Recruiting now

  • Kyushu University Hospital

    Higashi, Japan 812-8582

    Recruiting now

  • Cancer Institute Hospital of Jfcr

    Koto-Ku, Tokyo, Japan 135-8550

    Recruiting now
    • (contact)0335200111
    • KENJI NAKANO, MD(principal investigator)

  • Okayama University Hospital

    Okayama, Japan 700-8558

    Recruiting now
    • (contact)+81 86 235 7534[email protected]
    • Tomohiro Fujiwara, MD(principal investigator)
    • Toshifumi Ozaki, MD(sub investigator)
    • Eiji Nakata, MD(sub investigator)
    • Kiichiro Ninomiya, MD(sub investigator)
    • Ayako Morita, MD(sub investigator)
    • Go Makimoto, MD(sub investigator)
    • Eiki Ichihara, MD(sub investigator)
    • Kotaro Yamada, MD(sub investigator)
    • Miho Fujiwara, MD(sub investigator)
    • Takahiro Baba, MD(sub investigator)
    • Kammei Rai, MD(sub investigator)
    • Masahiro Tabata, MD(sub investigator)

  • Universitair Medisch Centrum Groningen (Umcg)

    Groningen, Netherlands 9713 GZ

    Recruiting now

  • Leids Universitair Medisch Centrum

    Leiden, Netherlands 2333 ZA

    Recruiting now

  • Radboud Umc

    Nijmegen, Netherlands 6525 GA

    Recruiting now

  • Pan American Center For Oncology Trials, LLC

    Rio Piedras, Puerto Rico 00935

    Recruiting now

  • Seoul National University Hospital

    Seoul, South Korea 03080

    Recruiting now

  • Severance Hospital

    Seoul, South Korea 03722

    Recruiting now

  • Asan Medical Center

    Seoul, South Korea 05505

    Recruiting now

  • Samsung Medical Center

    Seoul, South Korea 06351

    Recruiting now

  • Hospital Universitario Valle de Hebrón - Vhio

    Barcelona, Spain 08035

    Recruiting now

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, Spain 08041

    Recruiting now

  • Hospital de Bellvitge - Ico

    L'Hospitalet de Llobregat, Spain 08908

    Recruiting now

  • Hospital General Universitario Gregorio

    Madrid, Spain 28007

    Recruiting now

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, Spain 28040

    Recruiting now

  • Hospital Universitario La Paz

    Madrid, Spain 28046

    Recruiting now

  • Hospital Universitario Y Politecnico La Fe

    Valencia, Spain 46026

    Recruiting now

  • National Taiwan University Hospital

    Taipei, Taiwan 100225

    Recruiting now

  • Taipei Veterans General Hospital

    Taipei, Taiwan 112201

    Recruiting now

  • Western General Hospital

    Edinburgh, United Kingdom

    Recruiting now

  • Royal Marsden Hospital

    London, United Kingdom

    Recruiting now

  • UCLH

    London, United Kingdom

    Recruiting now

  • Christie Hospital

    Manchester, United Kingdom M20 4BX

    Recruiting now

  • Churchill Hospital

    Oxford, United Kingdom

    Recruiting now
See the official eligibility language

Shown exactly as written on ClinicalTrials.gov. Your oncologist is the right person to judge whether it fits your situation.

Inclusion Criteria:

* Have a histopathological diagnosis (fresh or banked tumor biopsy sample collected within the last 3 years) consistent with locally advanced or metastatic conventional chondrosarcoma 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 provided measurable disease falls outside of the treatment field or within the field and has shown ≥20% growth in size since post-treatment assessment.
* Have received 0 or 1 prior systemic treatment regimen in the advanced/metastatic setting for chondrosarcoma.
* Have radiographic progression/recurrence of disease according to RECIST v1.1 defined as:

  1. Radiographic progression of disease (local and/or distant) documented by 2 imaging assessments performed no more than 6 months (±2 weeks) apart within 12 months before randomization.

     OR
  2. Any recurrence of disease (local and/or distant) after complete surgical resection and documented by imaging within 6 months (±2 weeks) before randomization.
* Have documented IDH1 gene-mutated disease (from a fresh tumor biopsy or the most recent banked tumor tissue available that was sourced from either a primary or metastatic tumor lesion) based on central laboratory testing (R132C/L/G/H/S mutation variants tested)
* Have recovered from any clinically relevant sequelae and toxic effects of any prior surgery, radiotherapy, or other therapy intended for the treatment of cancer.

Exclusion Criteria:

* Are unable to swallow oral medication.
* Pregnant or lactating women.
* Are participating in another interventional study at the same time; participation in noninterventional registries or epidemiological studies is allowed.
* Have received prior therapy with an IDH1 inhibitor
* Have received systemic anticancer therapy \<2 weeks prior to randomization (for investigational 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 are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued or reduced corticosteroid treatment \<=10 mg per day for these metastases for at least 4 weeks and have radiographically stable disease of brain lesions for at least 3 months prior to randomization.
* Have a history of another primary cancer, with the exception of: a) curatively resected 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 primary solid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in the opinion of the Investigator, the disease will not affect participant's outcome in the 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 heart failure; myocardial infarction; unstable angina; and/or stroke.
* Have LVEF \<40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization.
* Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec 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 may be permitted based on local cardiology assessment.
* Have known medical history of progressive multifocal leukoencephalopathy (PML).

Updated 2026-02-06 on ClinicalTrials.gov. Always confirm current details with the study team or your oncologist.