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New hope for rare bone cancer: targeted pill slows tumor growth?

NCT ID NCT06127407

Disease control Sponsor: Servier Bio-Innovation LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests ivosidenib, a daily pill that targets a specific genetic mutation (IDH1), in 136 adults with advanced or metastatic conventional chondrosarcoma that cannot be surgically removed. Participants are randomly assigned to receive either ivosidenib or a placebo. The main goal is to see if the drug delays cancer progression, especially in lower-grade tumors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ivosidenib
What this could lead to
If successful, this could provide a targeted treatment option to slow tumor growth in people with a rare bone cancer that has few effective therapies.
What could go wrong
This is an early Phase 3 trial with only 136 participants, so results may not apply to all patients. The drug may not improve survival or could cause side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 136 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Nov 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

chondrosarcoma Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Locally advanced or metastatic conventional chondrosarcoma with an IDH1 mutation, untreated or previously treated with 1 systemic treatment regimen

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    114 sites in 17 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus, 8200, Denmark

  • Alberta Health Services

    RECRUITING

    Calgary, Alberta, T2N-5G2, Canada

  • Aou Policlinico Paolo Giaccone

    RECRUITING

    Palermo, 90127, Italy

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, 100142, China

  • Beijing Jishuitan Hospital

    RECRUITING

    Beijing, 102208, China

  • CIONC

    RECRUITING

    Curitiba, 80810-050, Brazil

  • Cancer Institute Hospital of Jfcr

    RECRUITING

    Koto-Ku, Tokyo, 135-8550, Japan

  • Centre Multidisciplinaire de Oncologie Medicale

    RECRUITING

    Liège, 4000, Belgium

  • Centre Oscar Lambret

    RECRUITING

    Lille, 59020, France

  • Cepon - Centro de Pesquisas Oncologicas

    RECRUITING

    Florianópolis, 88034-000, Brazil

  • Charite Universitatsmedizin

    RECRUITING

    Berlin, 13353, Germany

  • Chris O'Brien Lifehouse

    NOT_YET_RECRUITING

    Camperdown, 2050, Australia

  • Chris O'Brien Lifehouse

    RECRUITING

    Camperdown, 2050, Australia

  • Christie Hospital

    RECRUITING

    Manchester, M20 4BX, United Kingdom

  • Churchill Hospital

    RECRUITING

    Oxford, United Kingdom

  • Cleveland Clinic

    RECRUITING

    Cleveland, Ohio, 44195, United States

    Contact Email: •••••@•••••

  • Cliniques Universitaires St. Luc

    RECRUITING

    Brussels, 1200, Belgium

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Duke University

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory Winship Cancer Institute

    RECRUITING

    Atlanta, Georgia, 30308, United States

  • Flinders Medical Centre

    RECRUITING

    Bedford Park, 5042, Australia

  • Fukushima Medical University Hospital

    RECRUITING

    Fukushima, 960-1295, Japan

  • Fundação Amaral Carvalho - Jaú/ Sp

    RECRUITING

    Jaú, 17210-080, Brazil

  • Helios Klinikum Bad Saarow

    RECRUITING

    Bad Saarow, 15526, Germany

  • Henan Cancer Hospital

    RECRUITING

    Guangzhou, 450003, China

  • Herlev & Gentofte Hospital

    RECRUITING

    Herlev, 2730, Denmark

  • Hokkaido Cancer Center

    RECRUITING

    Sapporo, Hokkaido, 003-0804, Japan

  • Hopital de La Timone

    RECRUITING

    Marseille, 13005, France

  • Hospital A C Camargo

    RECRUITING

    São Paulo, 01509-010, Brazil

  • Hospital Albert Einstein

    RECRUITING

    São Paulo, 05652-900, Brazil

  • Hospital Das Clínicas Da Ufmg

    RECRUITING

    Belo Horizonte, 30130-100, Brazil

  • Hospital General Universitario Gregorio

    RECRUITING

    Madrid, 28007, Spain

  • Hospital Universitario Fundación Jiménez Díaz

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Valle de Hebrón - Vhio

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Y Politecnico La Fe

    RECRUITING

    Valencia, 46026, Spain

  • Hospital de Amor - Barretos

    RECRUITING

    Barretos, 14784-400, Brazil

  • Hospital de Bellvitge - Ico

    RECRUITING

    L'Hospitalet de Llobregat, 08908, Spain

  • Hospital de La Santa Creu I Sant Pau

    RECRUITING

    Barcelona, 08041, Spain

  • Hôpital Cochin

    RECRUITING

    Paris, 75014, France

  • Hôpital Léon Bérard

    RECRUITING

    Lyon, 69008, France

  • INSTITUT de CANCEROLOGIE de l'Ouest

    RECRUITING

    Saint-Herblain, 44805, France

  • Icesp - Instituto Do Câncer Do Estado de São Paulo

    RECRUITING

    São Paulo, 01246-000, Brazil

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

    RECRUITING

    São Paulo, 01409-902, Brazil

  • Institut Bergonié

    RECRUITING

    Bordeaux, 33076, France

  • Institut Gustave Roussy

    RECRUITING

    Villejuif, 94800, France

  • Instituto Nacional Do Câncer - Inca

    RECRUITING

    Rio de Janeiro, 20220-410, Brazil

  • Irccs Fondazione Istituto Nazionale Dei Tumori

    RECRUITING

    Milan, 20133, Italy

  • Irccs Istituto Ortopedico Rizzoli

    RECRUITING

    Bologna, 40136, Italy

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

    RECRUITING

    Roma, 00144, Italy

  • Istituto Oncologico Veneto Iov - Irccs

    RECRUITING

    Padova, 35128, Italy

  • Iuct-Oncopole Institut Universitaire Du Cancer

    RECRUITING

    Toulouse, 31059, France

  • Johns Hopkins University

    RECRUITING

    Baltimore, Maryland, 21287, United States

  • Kanazawa University Hospital

    RECRUITING

    Kanazawa, Ishikawa-ken, 920-8641, Japan

  • Kyushu University Hospital

    RECRUITING

    Higashi, 812-8582, Japan

  • Leids Universitair Medisch Centrum

    RECRUITING

    Leiden, 2333 ZA, Netherlands

  • Liga Norte Riograndense Contra O Cancer

    RECRUITING

    Natal, Rio Grande do Norte, 59062-000, Brazil

  • Lmu Klinikum

    RECRUITING

    München, 81377, Germany

  • Mayo Clinic - Jacksonville, Fl

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic - Rochester, Mn

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Cancer Center

    RECRUITING

    New York, New York, 10065, United States

  • Muhc Glen Site

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Nagoya University Hospital

    RECRUITING

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

  • National Cancer Center Hospital

    RECRUITING

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 100225, Taiwan

  • Nebraska Methodist Hospital

    RECRUITING

    Omaha, Nebraska, 68118, United States

  • Niigata University Medical and Dental General Hospital

    RECRUITING

    Chūōku, Niigata City, 951-8510, Japan

  • Oita University Hospital

    RECRUITING

    Yufu-Shi, Oita Prefecture, 879-5593, Japan

  • Okayama University Hospital

    RECRUITING

    Okayama, 700-8558, Japan

  • Oregon Health & Science University Knight Cancer Institute

    RECRUITING

    Portland, Oregon, 97239, United States

  • Osaka International Cancer Institute

    RECRUITING

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

  • Ospedale Santo Stefano

    RECRUITING

    Prato, 59100, Italy

  • Pan American Center For Oncology Trials, LLC

    RECRUITING

    Rio Piedras, 00935, Puerto Rico

  • Policlinico Universitario Campus Biomedico

    RECRUITING

    Roma, 00128, Italy

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, 4102, Australia

  • Radboud Umc

    RECRUITING

    Nijmegen, 6525 GA, Netherlands

  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University

    RECRUITING

    Chicago, Illinois, 60611-5975, United States

  • Royal Marsden Hospital

    RECRUITING

    London, United Kingdom

  • Samsung Medical Center

    RECRUITING

    Seoul, 06351, South Korea

  • San Luigi Gonzaga University Hospital of Turin

    RECRUITING

    Orbassano, 10043, Italy

  • Sarcoma Oncology Research Center

    RECRUITING

    Santa Monica, California, 90403, United States

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital

    RECRUITING

    Seoul, 03722, South Korea

  • Shanghai Changzheng Hospital

    RECRUITING

    Shang'ai, Shanghai Municipality, 200000, China

  • Shanghai General Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200080, China

  • Shanghai Ruijin Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Sir Charles Gairdner Hospital

    RECRUITING

    Nedlands, 6009, Australia

  • St Vincent'S Hospital Melbourne

    RECRUITING

    Fitzroy, 3065, Australia

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112201, Taiwan

  • The First Affiliated Hospital of Sun Yat-Sen University

    RECRUITING

    Guangzhou, Guangdong, 510080, China

  • The Ohio State University Comprehensive Cancer Center

    RECRUITING

    Columbus, Ohio, 43210, United States

  • The Second Affiliated Hospital Zhejiang University School of Medical

    RECRUITING

    Hangzhou, Zhejiang, 310025, China

  • The Univeristy of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • The Washington University

    RECRUITING

    St Louis, Missouri, 63110, United States

  • U.Z. Gent

    RECRUITING

    Ghent, 9000, Belgium

  • UCLH

    RECRUITING

    London, United Kingdom

  • Ukm - Sarkom-Zentrum

    RECRUITING

    Münster, 48149, Germany

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

    RECRUITING

    Wuhan, Hubei, 430023, China

  • Universitaetsklinikum Ulm

    RECRUITING

    Ulm, 89081, Germany

  • Universitair Medisch Centrum Groningen (Umcg)

    RECRUITING

    Groningen, 9713 GZ, Netherlands

    Contact Email: •••••@•••••

  • Universitatsklinikum Hamburg-Eppendorf

    RECRUITING

    Hamburg, 20246, Germany

  • University Health Network

    RECRUITING

    Toronto, Ontario, M5G 2M9, Canada

  • University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

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

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Miami

    RECRUITING

    Miami, Florida, 33136-1002, United States

  • University of Pittsburgh Medical Center-Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Universitätsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

    Contact Email: •••••@•••••

  • Universitätsmedizin Mannheim (Umm)

    RECRUITING

    Mannheim, 68167, Germany

  • Usc Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37232, United States

  • West China Hopital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Western General Hospital

    RECRUITING

    Edinburgh, United Kingdom

  • Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06511, United States