Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
NCT ID: NCT06127407
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
136 participants
INTERVENTIONAL
2024-07-09
2030-11-26
Brief Summary
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Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ivosidenib
Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years).
Ivosidenib 500mg
Provided as tablets, taken orally as two 250mg tablets once daily.
Placebo
Taken continuously until BICR-confirmed disease progression, unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, lost to follow-up, or the Sponsor ends the study (estimated average treatment duration of two years). Participants randomized to the placebo arm who experience BICR-confirmed disease progression and meet the crossover eligibility criteria will be given the opportunity to cross over and receive ivosidenib.
Placebo
Provided as tablets, taken orally once daily.
Interventions
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Ivosidenib 500mg
Provided as tablets, taken orally as two 250mg tablets once daily.
Placebo
Provided as tablets, taken orally once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
No
Sponsors
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Institut de Recherches Internationales Servier
OTHER
Servier Bio-Innovation LLC
INDUSTRY
Responsible Party
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Locations
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Usc Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sarcoma Oncology Research Center
Santa Monica, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Mayo Clinic - Jacksonville, Fl
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Emory Winship Cancer Institute
Atlanta, Georgia, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
Iowa City, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic - Rochester, Mn
Rochester, Minnesota, United States
The Washington University
St Louis, Missouri, United States
Nebraska Methodist Hospital
Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Oregon Health & Science University Knight Cancer Institute
Portland, Oregon, United States
University of Pittsburgh Medical Center-Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
The Univeristy of Texas Md Anderson Cancer Center
Houston, Texas, United States
Flinders Medical Centre
Bedford Park, , Australia
Chris O'Brien Lifehouse
Camperdown, , Australia
Chris O'Brien Lifehouse
Camperdown, , Australia
St Vincent'S Hospital Melbourne
Fitzroy, , Australia
Sir Charles Gairdner Hospital
Nedlands, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Cliniques Universitaires St. Luc
Brussels, , Belgium
U.Z. Gent
Ghent, , Belgium
Centre Multidisciplinaire de Oncologie Medicale
Liège, , Belgium
Liga Norte Riograndense Contra O Cancer
Natal, Rio Grande do Norte, Brazil
Hospital de Amor - Barretos
Barretos, , Brazil
Hospital Das Clínicas Da Ufmg
Belo Horizonte, , Brazil
CIONC
Curitiba, , Brazil
Cepon - Centro de Pesquisas Oncologicas
Florianópolis, , Brazil
Fundação Amaral Carvalho - Jaú/ Sp
Jaú, , Brazil
Instituto Nacional Do Câncer - Inca
Rio de Janeiro, , Brazil
Icesp - Instituto Do Câncer Do Estado de São Paulo
São Paulo, , Brazil
Impar Serviços Hospitalares S.A. - Hospital Nove de Julho
São Paulo, , Brazil
Hospital A C Camargo
São Paulo, , Brazil
Hospital Albert Einstein
São Paulo, , Brazil
Alberta Health Services
Calgary, Alberta, Canada
University Health Network
Toronto, Ontario, Canada
Muhc Glen Site
Montreal, Quebec, Canada
The First Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Shanghai Changzheng Hospital
Shang'ai, Shanghai Municipality, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
West China Hopital of Sichuan University
Chengdu, Sichuan, China
The Second Affiliated Hospital Zhejiang University School of Medical
Hangzhou, Zhejiang, China
Beijing Cancer Hospital
Beijing, , China
Beijing Jishuitan Hospital
Beijing, , China
Henan Cancer Hospital
Guangzhou, , China
Aarhus Universitetshospital
Aarhus, , Denmark
Herlev & Gentofte Hospital
Herlev, , Denmark
Institut Bergonié
Bordeaux, , France
Centre Oscar Lambret
Lille, , France
Hôpital Léon Bérard
Lyon, , France
Hopital de La Timone
Marseille, , France
Hôpital Cochin
Paris, , France
INSTITUT de CANCEROLOGIE de l'Ouest
Saint-Herblain, , France
Iuct-Oncopole Institut Universitaire Du Cancer
Toulouse, , France
Institut Gustave Roussy
Villejuif, , France
Helios Klinikum Bad Saarow
Bad Saarow, , Germany
Charite Universitatsmedizin
Berlin, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Universitatsklinikum Hamburg-Eppendorf
Hamburg, , Germany
Universitätsmedizin Mannheim (Umm)
Mannheim, , Germany
Lmu Klinikum
München, , Germany
Ukm - Sarkom-Zentrum
Münster, , Germany
Universitaetsklinikum Ulm
Ulm, , Germany
Irccs Istituto Ortopedico Rizzoli
Bologna, , Italy
Irccs Fondazione Istituto Nazionale Dei Tumori
Milan, , Italy
San Luigi Gonzaga University Hospital of Turin
Orbassano, , Italy
Istituto Oncologico Veneto Iov - Irccs
Padua, , Italy
Aou Policlinico Paolo Giaccone
Palermo, , Italy
Ospedale Santo Stefano
Prato, , Italy
Policlinico Universitario Campus Biomedico
Roma, , Italy
Istituti Fisioterapici Ospitalieri (Ifo) - Istituto Nazionale Tumori Regina Elena (Ire)
Roma, , Italy
Hokkaido Cancer Center
Sapporo, Hokkaido, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Nagoya University Hospital
Shōwaku, Nagoya-shi, Aichi, Japan
Niigata University Medical and Dental General Hospital
Chūōku, Niigata City, Japan
Oita University Hospital
Yufu-Shi, Oita Prefecture, Japan
Osaka International Cancer Institute
Chūōku, Osaka-shi, Osaka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, , Japan
Fukushima Medical University Hospital
Fukushima, , Japan
Kyushu University Hospital
Higashi, , Japan
Cancer Institute Hospital of Jfcr
Koto-Ku, Tokyo, , Japan
Okayama University Hospital
Okayama, , Japan
Universitair Medisch Centrum Groningen (Umcg)
Groningen, , Netherlands
Leids Universitair Medisch Centrum
Leiden, , Netherlands
Radboud Umc
Nijmegen, , Netherlands
Pan American Center For Oncology Trials, LLC
Rio Piedras, , Puerto Rico
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital Universitario Valle de Hebrón - Vhio
Barcelona, , Spain
Hospital de La Santa Creu I Sant Pau
Barcelona, , Spain
Hospital de Bellvitge - Ico
L'Hospitalet de Llobregat, , Spain
Hospital General Universitario Gregorio
Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Y Politecnico La Fe
Valencia, , Spain
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Western General Hospital
Edinburgh, , United Kingdom
Royal Marsden Hospital
London, , United Kingdom
UCLH
London, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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Central Contacts
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Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
Role: CONTACT
Phone: +33 1 55 72 60 00
Email: [email protected]
Facility Contacts
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Victoria Chua-Alcala, MD
Role: primary
Sharon Huie
Role: primary
Steven Attia, Dr
Role: primary
William Read
Role: primary
DFCI Sarcoma Center
Role: primary
Role: primary
Richard Riedel, MD
Role: primary
Role: primary
Luiza Stoeva
Role: primary
OHSU Clinical Trials Office
Role: primary
Clinical Research Coordinator
Role: primary
Role: primary
Role: backup
Vivek Bhadri, MD
Role: primary
Melissa Moore, Dr
Role: primary
Vladimir Andelkovic, Dr
Role: primary
Matthew Young
Role: primary
Role: primary
Role: primary
Daniel Pink, MD
Role: primary
Simone Micheel
Role: backup
Uniklinik Dresden Studiensekretariat Onkologie
Role: primary
PD. Dr. med. Torsten Keßler
Role: primary
Dr. Lorenzo D'Ambrosio
Role: primary
Baldi Giacomo Giulio
Role: primary
Role: backup
Bruno Vincenzi, MD
Role: primary
Role: primary
Role: primary
Role: primary
Jacco de Haan
Role: primary
Hans Gelderblom
Role: primary
Ingrid Desar
Role: primary
Claudia Valverde
Role: primary
Nadia Hindi
Role: primary
Javier Martin Broto
Role: backup
Roberto Díaz Beveridge, MD
Role: primary
Wei-Wu Chen
Role: primary
Po-Kuei Wu
Role: primary
Carla Dalton
Role: primary
Anna Mazepa
Role: backup
References
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Tap WD, Cote GM, Burris H, Gore L, Elias A, Beeram M, Conley AP, Gianolio DA, Qu Z, Pandya S, Trent JC. Phase I Study of the Mutant IDH1 Inhibitor Ivosidenib: Long-term Safety and Clinical Activity in Patients with Conventional Chondrosarcoma. Clin Cancer Res. 2025 Jun 3;31(11):2108-2114. doi: 10.1158/1078-0432.CCR-24-4128.
Related Links
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CHONQUER Study Website
Other Identifiers
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CL3-95031-007
Identifier Type: -
Identifier Source: org_study_id