CL3-95031-007
Research type
Research Study
Full title
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 (CHONQUER study)
IRAS ID
1009431
Contact name
Sue Russell
Contact email
Sponsor organisation
Institut de Recherches Internationales Servier (I.R.I.S.)
Clinicaltrials.gov Identifier
Research summary
The aim of the study is to determine how effective and safe ivosidenib is in the treatment of locally advanced or metastatic conventional chondrosarcoma with an isocitrate dehydrogenase 1 (IDH1) mutation. Of note, ivosidenib has already been studied and approved for the treatment of other types of cancers.
After participant eligibility is confirmed (screening period of up to 28 days prior to randomisation), participants will be assigned treatment. Participants who meet all study eligibility criteria will receive either ivosidenib orally at a dose of 500 mg once daily (QD) or ivosidenib-matched oral placebo QD. Once treatment starts, participants will have to visit the clinic up to 3 times in the first month, then once a month thereafter. Daily study treatment will begin on C1D1. Cycles are 28 days in duration, and dosing is continuous. Participants will also be asked if they wish to participate in specific optional analyses during the study and if they agree with long term storage of their biological samples for future research purposes. These analyses and samples collection will allow for a more in-depth examination of the disease and the effects of the study treatment. During the study participants will be assessed regularly for safety. Assessemnts will include, radiographic imaging for evaluation of disease response, blood samples will also be collected to monitor for side effects. Participants may continue with their assigned study treatment until BICR-confirmed disease progression, development of unacceptable toxicity, confirmed pregnancy, death, withdrawal of consent, participant is lost to follow-up, or the Sponsor ends the study, whichever occurs first. Participants randomised to the placebo arm who meet the crossover eligibility criteria will be given the opportunity to crossover to the active treatment arm and receive ivosidenib.REC name
North of Scotland Research Ethics Committee 1
REC reference
24/NS/0114
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion