At a glance
ClinicalIndex Comparison Record- ✓Histopathological diagnosis of locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3, not eligible for curative resection
- ✓At least one BICR-confirmed measurable lesion by RECIST v1.1
- ✓0 or 1 prior systemic treatment regimen in advanced/metastatic setting for chondrosarcoma
- ✓Radiographic progression or recurrence of disease by RECIST v1.1 within specified timeframes
- ✕Unable to swallow oral medication
- ✕Pregnant or lactating women
- ✕Participating in another interventional study concurrently
- ✕Prior therapy with an IDH1 inhibitor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Ivosidenib 500mg and Placebo for Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen. Currently recruiting, targeting 136 participants across 114 sites in 17 countries.
Detailed Summary
Study CL3-95031-007 (CHONQUER) is a Phase 3, international, multicenter, double-blind, randomized, placebo-controlled study of orally administered ivosidenib. Participants are required to have a histopathological diagnosis consistent with isocitrate dehydrogenase-1 (IDH1) gene-mutated, locally advanced or metastatic conventional chondrosarcoma Grades 1, 2, or 3 and not eligible for curative resection. IDH1 mutant status will be determined during pre-screening/screening phase. Participant must have radiographic progression/recurrence of disease according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) and have received 0 to 1 prior systemic treatment regimen in the advanced/metastatic setting for conventional chondrosarcoma. The primary endpoint is progression-free survival (PFS) in Grades 1 and 2 participants. Key secondary endpoints are PFS in all randomized participants, overall survival (OS) in Grades 1 and 2 participants, and OS in all randomized participants. Participants who meet enrollment criteria will be randomized 1:1 to receive oral ivosidenib 500mg once daily, or a matching placebo once daily.
Study Details
Timeline
Interventions
Provided as tablets, taken orally as two 250mg tablets once daily.
Provided as tablets, taken orally once daily.