Locally advanced or metastatic conventional chondrosarcoma with an IDH1 mutation, untreated or previously treated with 1 systemic treatment regimen
Conditions
Brief summary
Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants
Detailed description
PFS based on BICR assessment in all randomized participants, Overall survival (OS) in Grade 1 and Grade 2 participants, OS in all randomized participants, PFS based on Investigator assessment in Grade 1 and Grade 2 participants and in all randomised participants, Objective response (OR) (complete response(CR) or partial response (PR)) of anti-tumor activity (using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of response (DOR) in Grade 1 and Grade 2 participants and in all randomised participants, Time to response (TTR) in Grade 1 and Grade 2 participants and in all randomised participants, Disease control (DC) CR, PR, or stable disease (SD)) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of disease control (DoDC) in Grade 1 and Grade 2 participants and in all randomised participants, Number of Adverse Events (AEs), Number of Serious Adverse Events (SAEs), Number of Adverse Events of Special Interest (AESIs), Number of Adverse Events (AEs) leading to discontinuation, treatment interruption, and dose reduction, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) score, European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) score, Patient-Reported Outcomes Measurement Information System (PROMIS) score, Ivosidenib and 2-hydroxyglutarate (2-HG) concentration in plasma
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS) based on Blinded Independent Central Reviewer (BICR) assessment in Grade 1 and Grade 2 participants | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS based on BICR assessment in all randomized participants, Overall survival (OS) in Grade 1 and Grade 2 participants, OS in all randomized participants, PFS based on Investigator assessment in Grade 1 and Grade 2 participants and in all randomised participants, Objective response (OR) (complete response(CR) or partial response (PR)) of anti-tumor activity (using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of response (DOR) in Grade 1 and Grade 2 participants and in all randomised participants, Time to response (TTR) in Grade 1 and Grade 2 participants and in all randomised participants, Disease control (DC) CR, PR, or stable disease (SD)) in Grade 1 and Grade 2 participants and in all randomised participants, Duration of disease control (DoDC) in Grade 1 and Grade 2 participants and in all randomised participants, Number of Adverse Events (AEs), Number of Serious Adverse Events (SAEs), Nu | — |
Countries
Belgium, Denmark, France, Germany, Italy, Netherlands, Spain