All studies
RecruitingPHASE3INTERVENTIONAL

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

This research study, called CHONQUER, is looking into a potential new treatment called ivosidenib for adults with a type of bone cancer called chondrosarcoma. Specifically, it's for those whose cancer has spread or can't be removed, and has a particular genetic fault (an IDH1 mutation). This study compares ivosidenib, taken as a pill, with a placebo (a dummy pill with no active drug) to understand if ivosidenib can help slow down the cancer's progression and improve life expectancy. Participants will be randomly assigned to receive either ivosidenib or the placebo. The main goal is to see how long people live without their cancer growing, and how long they live overall. This is a 'Phase 3' trial, which means it's a key step in testing if this treatment is effective and safe.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Servier Bio-Innovation LLC
Enrolment target
136
Start
09 Jul 2024
Estimated completion
26 Nov 2030

What is this study about?

Chondrosarcoma is a type of cancer that starts in cartilage cells, which are found in bones. When this cancer is advanced, meaning it has either spread to other parts of the body or can't be completely removed by surgery, treatment options can be limited. This particular study is focusing on a specific subgroup of chondrosarcoma patients: those whose cancer has a particular genetic change, called an IDH1 mutation. This mutation is like a tiny error in the cancer's genetic code.

Researchers are investigating a new drug called ivosidenib, which is designed to specifically target this IDH1 mutation, potentially slowing down the cancer's growth. The study aims to find out if ivosidenib is better than a placebo (a dummy pill) at stopping the cancer from getting worse and helping people live longer. By participating, you could help doctors understand if ivosidenib is an effective and safe treatment option for this type of chondrosarcoma.

This is an important Phase 3 study, which means it's a late-stage trial. If the results are positive, ivosidenib could become a new approved treatment. The information gathered will be vital for improving how we treat chondrosarcoma with this specific genetic change in the future.

Key takeaways

  • This study tests a new drug, ivosidenib, for advanced chondrosarcoma with an IDH1 mutation.
  • It compares ivosidenib to a placebo (dummy pill) to see if it slows cancer growth.
  • You would take one pill a day and have regular check-ups and scans.
  • The study is for adults whose cancer has spread or is inoperable, and has an IDH1 mutation.
  • Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

This study is for adults, aged 18 and over, who have a diagnosis of chondrosarcoma. Your cancer should either be advanced (meaning it has spread) or not operable, and it must have a specific genetic change called an IDH1 mutation. This mutation will be checked with a special test during the study screening process.

Your cancer also needs to have shown some growth or come back recently, as confirmed by scans. You might have received either no previous systemic treatment (like chemotherapy or immunotherapy) for your advanced cancer, or just one type of systemic treatment. You should generally be well enough to take oral medication and have recovered from any major effects of previous treatments like surgery or radiotherapy.

However, you cannot join this study if you are pregnant or breastfeeding, if you are already taking part in another drug trial, or if you have previously had a medicine that specifically targets the IDH1 mutation. Also, you must be able to swallow pills.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced chondrosarcoma with an IDH1 genetic change?
  3. Has your cancer shown recent growth or come back on scans?
  4. Have you had 0 or 1 previous systemic treatment for advanced chondrosarcoma?
  5. Are you able to swallow pills easily?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned, like flipping a coin, to receive either ivosidenib or a matching placebo (a dummy pill). You will take one pill by mouth once a day. The study involves regular visits to the clinic for assessments, which will include physical examinations, blood tests, and scans (like CT or MRI) to check on your cancer. These scans will help doctors see if the treatment is working and if your cancer is growing or shrinking. The specific schedule of visits and tests will be provided by the study team, but typically involves more frequent visits at the beginning, becoming less frequent over time. You will continue treatment and follow-up for as long as the treatment is benefiting you, or until you experience unacceptable side effects or choose to stop.

Potential risks and benefits

Taking part in this study could potentially offer benefits, such as receiving a new investigational drug that may help control your cancer. However, there are no guarantees, and ivosidenib might not work for everyone. Like all medicines, ivosidenib can have side effects, which could range from mild to serious. The study team will monitor you closely for any side effects and provide appropriate care. You will be fully informed about these potential risks and benefits before you decide to participate. Crucially, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (114)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Usc Norris Comprehensive Cancer Center
    Verified postcode
    Los Angeles, United States· Recruiting
  • Sarcoma Oncology Research Center
    Verified postcode
    Santa Monica, United States· Recruiting
  • University of Colorado Cancer Center
    Verified postcode
    Aurora, United States· Recruiting
  • Yale Cancer Center
    Verified postcode
    New Haven, United States· Recruiting
  • Mayo Clinic - Jacksonville, Fl
    Verified postcode
    Jacksonville, United States· Recruiting
  • University of Miami
    Verified postcode
    Miami, United States· Recruiting
  • Emory Winship Cancer Institute
    Verified postcode
    Atlanta, United States· Recruiting
  • Robert H. Lurie Comprehensive Cancer Center of Northwestern University
    Verified postcode
    Chicago, United States· Recruiting
  • University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center
    Verified postcode
    Iowa City, United States· Recruiting
  • Johns Hopkins University
    Verified postcode
    Baltimore, United States· Recruiting
  • Dana-Farber Cancer Institute
    Verified postcode
    Boston, United States· Recruiting
  • Mayo Clinic - Rochester, Mn
    Verified postcode
    Rochester, United States· Recruiting

Common questions

What is chondrosarcoma?

Chondrosarcoma is a type of cancer that starts in the cartilage, which is the tough, flexible tissue found in your body, often in bones.

What is an IDH1 mutation?

An IDH1 mutation is a specific genetic change or 'fault' found in the cancer cells of some people with chondrosarcoma. This study drug is designed to target this specific change.

What is a placebo?

A placebo is a 'dummy' pill or treatment that looks exactly like the study drug but contains no active medicine. It helps researchers fairly compare the new drug's effects.

Will I know if I'm getting the drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your study doctor will know whether you are receiving ivosidenib or the placebo. This helps ensure fair and unbiased results.

Can I stop participating in the study at any time?

Yes, your participation is completely voluntary, and you can withdraw from the study at any point without it affecting your medical care.

How to find out more

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Ivosidenib in Participants With Locally Advanced or Metastat…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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