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

Study acronym: CHONQUER
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 2 of 114 sitesv25
  2. Study sites: 108 to 114v24
  3. Study sites: 107 to 108v23
  4. Re-verified, no change to tracked fieldsv22
  5. Study sites: 98 to 107v21
Show 19 earlier versionsHide 19 earlier versions
  1. Study sites: 76 to 98v20
  2. Study sites: 70 to 76v19
  3. Site contacts updated at 8 of 70 sitesv18
  4. Study sites: 59 to 70v17
  5. Study sites: 51 to 59v16
  6. Study sites: 45 to 51v15
  7. Site details revised at 2 of 45 sitesv14
  8. Site contacts updated at 1 of 45 sitesv13
  9. Study sites: 44 to 45v12
  10. Study sites: 39 to 44v11
  11. Study sites: 33 to 39v10
  12. Site contacts updated at 2 of 33 sitesv9
  13. Study sites: 25 to 33v8
  14. Study sites: 19 to 25v7
  15. Study sites revised (19)v6 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 12 to 19v5
  17. Study sites: 7 to 12v4
  18. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Dec 2026 to Feb 1, 2028 · Study sites: 0 to 7 · Completion date: Apr 2031 to Nov 26, 2030 · 1 morev3 Show 4 more changesShow less
    • Primary completion date: Dec 2026 to Feb 1, 2028
    • Study sites: 0 to 7
    • Completion date: Apr 2031 to Nov 26, 2030
    • Start date changed from estimate of Jun 7, 2024 to Jul 9, 2024
  19. Start date: Apr 1, 2024 to Jun 7, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06127407
Lead Sponsor Servier Bio-Innovation LLC
Collaborators: Institut de Recherches Internationales Servier
Conditions Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov