(I.R.I.S.) Servier / CL3-95031-007

Official 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

Study Purpose

To assess how well the drug Ivosidenib works against chondrosarcoma

Diagnosis

locally advanced or metastatic conventional chondrosarcoma with an isocitrate dehydrogenase-1 (IDH1) mutation, untreated or previously treated with 1 systemic treatment regimen.

Eligibility

This study will include participants ≥18 years of age with locally advanced or metastatic conventional

chondrosarcoma with an isocitrate dehydrogenase-1 (IDH1) mutation, untreated or previously treated with

1 systemic treatment regimen.

 

Intervention

Participants will be randomized 1:1 to ivosidenib or a matched placebo control.

Patients on placebo will cross over to drug at progression