Ivosidenib in Conventional Chondrosarcoma (CHONQUER)

 

Trial name: Ivosidenib in conventional chondrosarcoma
Agents: Ivosidenib, placebo
Phase III
Status Recruiting
Sponsor Servier Bio-Innovation LLC

 

This study is a randomized, double-blinded, placebo-controlled phase 3 study of Ivosidenib in locally advanced or metastatic conventional chondrosarcoma patients.

Further information can be found on clinicaltrials.gov.

 

WHO is the trial for?
  • Adult patients with locally advanced or metastatic conventional chondrosarcoma grade 1, 2 or 3 that is not operable
  • Patients with progression of disease, who have received 0 or 1 prior systemic treatment regimen in the advanced/metastatic setting for chondrosarcoma
  • Patients with documented IDH1 gene-mutated disease

WHAT is the key question that this trial is attempting to answer?

 The study evaluates the efficacy, tolerability and quality of life of patients receiving ivosidenib who have locally advanced or metastatic unresectable (inoperable) conventional chondrosarcoma with confirmed IDH1 gene mutation.

WHY patients might want to participate?

 This clinical trial offers patients an opportunity to access a new therapy strategy. This trial will further support the research in sarcoma and potentially help other patients with this disease.

The trial might or might not have benefit in your individual case.

WHEN will the trial be open?

 The study is open for recruitment.

WHERE is the trial available?

 The trial is currently active in Japan, but more countries will open the study in due course.

Please check for current information here.

STUDY DESIGN: What does the study look like?

 There are 2 study arms (groups): all participating patients will be randomly divided (by a computer) in two groups. Patients in one group will be assigned to ivosidenib, the other group will receive placebo.

Both will be given tablets, taken orally (by mouth).

In case of progression patients will be given the opportunity to cross over and receive ivosidenib.

HOW do I get more information?

 Patient organizations supporting sarcoma patients in your country may offer additional information about the trial, current recruitment status, and key contacts. Click here for a list of patient organizations serving sarcoma patients. If there are no such organization in your country, please email us for more information: info@sarcoma-patients.org

Disclaimer: This is a patient-friendly summary of the clinical trial which has been provided for informational purposes only. Patients should consult their physician about any clinical trial opportunity.

Merken