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Study of ivosidenib in adults with advanced or metastatic chondrosarcoma with IDH1 mutation who are untreated or have had one prior treatment

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on conventional chondrosarcoma, a type of bone cancer that has spread locally or to other parts of the body (locally advanced or metastatic) and contains a specific genetic change called an IDH1 mutation. The study will test a medication called ivosidenib (also known as AG-120/S95031), which is given as film-coated tablets taken by mouth.

The purpose of this research is to determine how well ivosidenib works in treating patients with Grade 1 and Grade 2 chondrosarcoma. The study will compare ivosidenib to a placebo in patients who have either not received any previous systemic treatment or have had one prior treatment for their cancer. Participants will be randomly assigned to receive either ivosidenib tablets or matching placebo tablets.

During the study, participants will take the study medication daily. The treatment may continue for up to 24 months. Throughout the study, doctors will monitor the participants' health and perform regular assessments to check how their cancer responds to the treatment. The study will measure how long participants live without their cancer getting worse, along with other factors such as overall survival and quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment assignment

    You will be randomly assigned to receive either ivosidenib tablets or placebo tablets. The study is double-blind, which means neither you nor the doctor will know which treatment you are receiving.

    The medication will be in the form of film-coated tablets for oral use.

  2. Step 2

    Treatment period

    You will take the assigned medication orally according to the prescribed schedule.

    Regular imaging scans will be performed to monitor your condition and assess how the tumor responds to treatment.

    Your doctor will monitor your health status through various tests and examinations.

  3. Step 3

    Health assessments

    Your tumor will be evaluated using imaging scans to measure any changes in size.

    You will complete several questionnaires about your quality of life and health status, including:

    - Quality of life assessment (EORTC QLQ-C30)

    - Health status evaluation (EQ-5D-5L)

    - Additional health-related questions (PROMIS)

    Blood samples will be collected to measure drug and 2-HG levels in your plasma.

  4. Step 4

    Safety monitoring

    Your doctor will monitor and record any side effects or health changes throughout the study.

    Regular check-ups will be conducted to ensure your safety during the trial.

    The study team will track any adverse events that may occur during treatment.

  5. Step 5

    Study duration

    The study is expected to run from May 2024 to April 2031.

    Your individual participation duration will be determined by how your condition responds to the treatment.

Who can join the trial?

9 criteria

  • You must have a confirmed diagnosis of conventional chondrosarcoma (a type of bone tumor) that is either locally advanced or has spread to other parts of the body (metastatic), with grades 1, 2, or 3, diagnosed within the last 3 years
  • Your tumor must have a specific genetic change called an IDH1 mutation (R132C/L/G/H/S variants), which must be confirmed by laboratory testing
  • You must have at least one measurable tumor that can be assessed by imaging scans
  • Your disease must show progression, demonstrated by either:
    • Growth of tumor shown on two imaging scans taken no more than 6 months apart within the last year
    • Return of disease within 6 months after complete surgical removal
    • For Grade 1 and 2 tumors, you should have received either no previous systemic treatment (like chemotherapy) or only one previous treatment. For Grade 3 tumors, up to two previous treatments are allowed
    • Your tumor must not be suitable for complete surgical removal or other local treatments like radiation therapy
    • If you had previous treatments (surgery, radiation, or other cancer therapies), you must have recovered from their side effects
    • If you previously received radiation therapy, your measurable tumor must either be outside the treated area or show at least 20% growth in the treated area after radiation

Who cannot join the trial?

14 criteria

  • Age under 18 years old
  • Presence of any brain metastases (cancer that has spread to the brain) that are not fully treated
  • Previous treatment with more than 1 systemic therapy (medications that travel through the bloodstream)
  • Pregnant or breastfeeding women
  • Severe heart problems, including:
    • Uncontrolled high blood pressure
    • Recent heart attack
    • Unstable heart rhythm disorders
    • Severe liver problems or abnormal liver function tests
    • Severe kidney problems or abnormal kidney function tests
    • Active, uncontrolled infections
    • Other types of cancer within the past 3 years (except for adequately treated non-melanoma skin cancer or cervical cancer in situ)
    • Any medical condition that, in the opinion of the study doctor, would make it unsafe to participate in the trial
    • Unable to swallow oral medications
    • Known allergic reactions to similar medications
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Investigated drugs

Ivosidenib is a medication used to treat certain types of cancer, specifically chondrosarcoma with an IDH1 mutation. It works by blocking a specific enzyme that is altered in cancer cells. This medication is designed to help patients who have locally advanced or metastatic conventional chondrosarcoma, either as their first treatment or after they have already received one previous treatment. It is taken orally and targets the specific genetic mutation (IDH1) found in the tumor cells.

What is already known about the treatment

Ivosidenib - An oral targeted therapy medication that works by inhibiting mutated IDH1 (isocitrate dehydrogenase-1) enzymes in cancer cells. This medication is currently being investigated in clinical trials for treating locally advanced or metastatic conventional chondrosarcoma, a type of bone cancer with IDH1 mutations. It belongs to the class of targeted cancer therapies known as IDH inhibitors, and its mechanism of action involves blocking the abnormal production of an oncometabolite that contributes to cancer growth. The drug is administered in tablet form and represents a promising approach for patients with IDH1-mutated chondrosarcoma who have limited treatment options after previous therapy or are untreated.

Investigated diseases

Chondrosarcoma - A rare type of bone cancer that develops in cartilage cells. This cancer typically starts in the bones of the arms, legs, or pelvis, though it can occur in any part of the body where cartilage is present. The disease begins when cartilage cells start growing abnormally, forming tumors that can grow into and destroy healthy bone tissue. Conventional chondrosarcoma is the most common form of this cancer, and it can be classified into different grades based on how the cells look under a microscope. When described as locally advanced, it means the cancer has grown into nearby tissues, while metastatic indicates it has spread to other parts of the body. Some cases of chondrosarcoma have a specific mutation in the IDH1 gene, which affects how cells process energy.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508507-20-00Protocol codeCL3-95031-007Estimated enrolment156 patientsSponsorInstitut De Recherches Internationales Servier IRIS

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).