A Phase 3 Study of Ivosidenib in People With Conventional Chondrosarcoma

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Full Title

A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of Ivosidenib in Participants >/=18 Years of Age with Locally Advanced or Metastatic Conventional Chondrosarcoma with an IDH1 Mutation, Untreated or Previously Treated with 1 Systemic Treatment Regimen (CHONQUER Study)

Purpose

Researchers want to see how well ivosidenib works to treat conventional chondrosarcoma that has metastasized (spread). Chondrosarcoma is a type of bone cancer that forms in cartilage cells. The people in this study have metastatic conventional chondrosarcoma that has a mutation (change) in the IDH1 gene.

Ivosidenib blocks an abnormal form of the IDH1 protein. Abnormal IDH1 causes too much of a substance called 2-HG to be produced, which can fuel cancer growth. Ivosidenib is taken orally (by mouth).

If you join this study, you will be randomly assigned to get one of these treatments:

  • Ivosidenib
  • Placebo (inactive pill)

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic conventional chondrosarcoma with an IDH1 mutation.
  • Have completed prior anti-cancer treatment at least 2 weeks before taking the study therapy.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. William Tap at 646-888-4163.

Protocol

24-233

Phase

Phase III (phase 3)

Investigator

Co-Investigators

Diseases

ClinicalTrials.gov ID

NCT06127407