Phase 3 Study of Oral Ivosidenib in Adults With Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With Up to One Systemic Therapy

What this Trial Is About

Researchers are evaluating the use of oral ivosidenib in adults with locally advanced or metastatic conventional chondrosarcoma that has an IDH1 gene mutation. This Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study focuses on participants who have not had curative surgery and have experienced disease progression or recurrence. Participants may have had up to one prior systemic treatment for their advanced or metastatic chondrosarcoma. The study aims to measure progression-free survival as the primary outcome, especially in Grades 1 and 2 patients, along with overall survival and other efficacy and safety outcomes. Participants will be randomly assigned to receive either ivosidenib 500 mg orally once daily as two 250 mg tablets or a matching placebo. Treatment will continue until disease progression confirmed by blinded independent central review, unacceptable side effects, pregnancy, death, withdrawal, loss to follow-up, or study end, with an expected average treatment duration of about two years. Those on placebo who experience disease progression and meet criteria may cross over to receive ivosidenib. Throughout the study, participants will undergo regular imaging assessments to monitor tumor response using RECIST v1.1 criteria. Various patient-reported outcomes, adverse event monitoring, and laboratory tests including plasma ivosidenib and 2-hydroxyglutarate levels will be collected. The study includes follow-up for up to 5 years to evaluate long-term survival, disease control, and safety. The total participation duration varies depending on individual progression and study timelines.

Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen