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NCT06127407 · ClinicalTrials.gov registry record · Phase 3
Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen
A Phase 3 study of Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen, sponsored by Servier Bio-Innovation.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 136
- Enrollment target
- 20
- Study locations
NCT06127407 is a Phase 3 study of Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen that is actively recruiting participants, run by Servier Bio-Innovation. The registered enrollment target is 136 participants. The trial reports 20 study locations across 17 states.
The verdict
NCT06127407, a Phase 3 study of Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen, is actively recruiting participants, sponsored by Servier Bio-Innovation.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 136 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ivosidenib 500mg
Study Locations (20)
California
- Usc Norris Comprehensive Cancer Center - Los Angeles
- Sarcoma Oncology Research Center - Santa Monica
Florida
- Mayo Clinic - Jacksonville, Fl - Jacksonville
- University of Miami - Miami
Ohio
- Cleveland Clinic - Cleveland
- The Ohio State University Comprehensive Cancer Center - Columbus
Colorado
- University of Colorado Cancer Center - Aurora
Connecticut
- Yale Cancer Center - New Haven
Georgia
- Emory Winship Cancer Institute - Atlanta
Illinois
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University - Chicago
Iowa
- University of Iowa Hospitals & Clinics- Holden Comprehensive Cancer Center - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2024-07-09 |
| Est. Completion | 2030-11-26 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06127407
The ClinicalTrials.gov registry entry for NCT06127407 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Servier Bio-Innovation, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06127407 reports 20 study locations spanning 17 distinct geographic areas - top geographies include California, Florida, Ohio.
Frequently Asked Questions
What is clinical trial NCT06127407 about?
NCT06127407 is a clinical study titled "Ivosidenib in Participants With Locally Advanced or Metastatic Conventional Chondrosarcoma Untreated or Previously Treated With 1 Systemic Treatment Regimen". 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 advan...
What is the current status of trial NCT06127407?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 136 participants. The study started on 2024-07-09. Estimated completion is 2030-11-26.
What conditions does trial NCT06127407 study?
This clinical trial studies the following conditions: Locally Advanced or Metastatic Conventional Chondrosarcoma With an IDH1 Mutation, Untreated or Previously Treated With 1 Systemic Treatment Regimen.
What interventions are being tested in trial NCT06127407?
The interventions under investigation include: Placebo (DRUG), Ivosidenib 500mg (DRUG).
Who is sponsoring clinical trial NCT06127407?
This trial is sponsored by Servier Bio-Innovation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06127407 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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