Testing Ivosidenib against a placebo for locally advanced or metastatic conventional chondrosarcoma

Exclusion

• −Have a history of another primary cancer, with the exception of: a) curatively resected non-melanoma skin cancer; b) curatively treated carcinoma in situ; or c) pT1-2 prostatic cancer Gleason score \<6 or d) participant is free of other primary solid or liquid tumor for ≥ 1 year prior to the start of study treatment and, in the opinion of the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, the disease will not affect participant's outcome in the setting of current chondrosarcoma diagnosis.
• −Are unable to swallow oral medication.
• −Are participating in another interventional studyInterventional studyA study where participants are given something to see what happens.Read more → at the same time; participation in noninterventional registries or epidemiological studies is allowed.
• −Have received prior therapy with an IDH1 inhibitor
• −Have received systemic anticancer therapy \<2 weeks prior to randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more → (for investigational or immune-based anticancer therapy \<4 weeks).
• −Have received radiotherapy \<2 weeks prior to randomization.
• −Have significant active cardiac disease within 6 months prior to randomization, including New York Heart Association (NYHA) Class III or IV congestive heart failure; myocardial infarction; unstable angina; and/or stroke.
• −Have LVEF \<40% by ECHO scan (or by other methods according to institutional practice) obtained within 28 days prior to randomization.
• −Have a heart-rate corrected QT interval (using Fridericia's formula) (QTcF) ≥ 450 msec or other factors that increase the risk of QT prolongation or arrhythmic events (eg, heart failure, hypokalemia, family history of long QT interval syndrome). Participants with a bundle branch block combined with a prolonged QTcF interval may be permitted based on local cardiology assessment.
• −Have known medical history of progressive multifocal leukoencephalopathy (PML).
• −Pregnant or lactating women.
• −Have known symptomatic brain metastases requiring steroids \>10 mg per day prednisone (or equivalent). Participants with previously diagnosed brain metastases are eligible if they have completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to randomization, have discontinued or reduced corticosteroid treatment \<=10 mg per day for these metastases for at least 4 weeks and have radiographically stable disease of brain lesions for at least 3 months prior to randomization.
• −Have had major surgery within 4 weeks prior to randomization.