Purpose of this Study
We are doing this study to find out if a study drug called ivosidenib is a safe and effective option for locally advanced or metastatic conventional chondrosarcoma with an isocitrate dehydrogenase 1 (IDH1) mutation.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with advanced or metastatic conventional chondrosarcoma
- Have a documented IDH1 mutation
What is Involved?
Description
The study is divided into three periods: a screening period, study drug period, and follow-up period.
If you choose to join the study, you will:
- Go through a screening period which lasts no more than 28 days
- Agree to send a blood sample for genetic testing
- Have blood and urine tests, EKGs, ECHO, and physical exams
- Have tumor evaluation by CT, MRI, or PET-CT
- You will take the study drug or placebo once per day (2 pills)
- Neither you nor your study doctor will know if you are getting the study drug or placebo
- During study procedures, one "drug cycle" equals 28 days
Study Details
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)
Principal Investigator
Richard
Riedel
Protocol Number
PRO00115250
NCT ID
NCT06127407
Phase
III
Enrollment Status
Open to Enrollment