Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen (CHONQUER)
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Study description
For detailed information about the CHONQUER study and how to participate, please visit the dedicated website.
This study is needed is to test the drug ivosidenib as a potential treatment for a specific type of bone cancer called chondrosarcoma. Currently, there is no approved treatment for patients with advanced chondrosarcoma.
Advanced chondrosarcoma can be locally advanced or metastatic. Locally advanced means that the cancer has grown outside the part of the body where it started in but has not yet spread to other parts of the body. Metastatic means that the cancer has spread to other parts of the body. Surgery is usually the first treatment and the only way to try to cure it. However, the cancer often comes back after surgery, and these tumors do not respond well to other treatments, such as radiation or chemotherapy (treatment with medicines).
This study focuses on patients with chondrosarcoma with a specific gene change called an IDH1 mutation. These mutations lead to abnormal forms of IDH1 proteins in the cancer cells. When these proteins are present in abnormal forms, they produce too much 2-hydroxyglutarate (2-HG). This impairs normal cell functioning and may cause cells to become cancer cells.
Ivosidenib is a drug that blocks the activity of abnormal IDH1 proteins which reduces 2-HG levels in tumor cells back to normal levels. Ivosidenib has already been approved in many countries to treat bile duct cancer (cholangiocarcinoma) and certain blood cancers.
The main goal of the study is to see how well ivosidenib works in the treatment of locally advanced or advanced chondrosarcoma with an IDH1 mutation.
- Ivosidenib 500mg
- Placebo
- CL3-95031-007
Eligibility Criteria
Eligible age for the study
Sexes
Male/FemaleAccepts Healthy Volunteers
NoTo take part in the study, participants have to:
- Be adults aged 18 or older.
- Have a recent tumor tissue sample (called a biopsy) showing locally advanced or advanced chondrosarcoma that cannot be cured with surgery.
- Have received no more than one previous treatment for their locally advanced or advanced cancer.
- Have a confirmed IDH1 mutation.
Participants cannot take part in the study if:
- They have previously received a drug that blocks IDH1.
- They have received any other anticancer therapy or radiation in the 2 weeks before starting the study.
- Their cancer has spread to the brain, requiring treatment with steroids (medicines that reduces inflammation).
How is the study designed?
Participants keep taking the treatment until occurrence of the following: worsening of their disease, too severe side effects, pregnancy, death, decision to stop their participation, can’t be reached, or the Sponsor decides to end the study.
Provided as tablets, taken by mouth as two 250mg tablets once daily.
Participants keep taking the treatment until occurrence of the following: worsening of their disease, too severe side effects, pregnancy, death, decision to stop their participation, can’t be reached, or the Sponsor decides to end the study.
Those who are given a placebo and whose disease gets worse can switch to receive ivosidenib if they meet certain criteria.
Provided as tablets, taken by mouth once daily.