The purpose of this study is to use ODxET for analysis of specimens obtained from participants of the CHONQUER IMP clinical trial. The study is limited to molecular eligibility screening only.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
IDH1 mutation
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
N/A. Use of the ODxET for analysis of specimens obtained from participants of
the CHONQUER IMP clinical trial is limited to molecular eligibility screening
only and is not for the purposes of establishment or confirmation of the
clinical performance evaluation of the ODxET in the context of the CHONQUER IMP
clinical trial endpoints.
Secondary outcome
N/A
Background summary
The purpose of this study is to use ThermoFisher's Ion Torrent* Oncomine* Dx
Express Test (ODxET) to prospectively determine the IDH1 gene mutation status
of patients with locally advanced or metastatic conventional chondrosarcoma to
determine molecular eligibility for enrolment onto the Institut de Recherches
Internationales Servier (Servier) sponsored investigational medicinal product
(IMP) Phase 3 CHONQUER clinical trial (EU CT-number: 2023-508507-20-00). The
CHONQUER clinical trial is a randomized placebo-controlled study of ivosidenib
in adult patients with locally advanced or metastatic conventional
chondrosarcoma with an IDH1 mutation. The primary objective of the CHONQUER
clinical trial is to assess the efficacy of ivosidenib, an IDH1-mutated protein
inhibitor.
Study objective
The purpose of this study is to use ODxET for analysis of specimens obtained
from participants of the CHONQUER IMP clinical trial. The study is limited to
molecular eligibility screening only.
Study design
The ODxE Test will be used for prospective analysis of de-identified FFPE
samples collected from patients that are candidates for enrolment onto the
Servier-sponsored CHONQUER clinical trial. This analysis will be performed
centrally within Test Site 01- Life Technologies Clinical Services Lab (Life
Lab) in 910 Riverside Parkway Suite 60 West Sacramento, CA 95605. The analysis
using the ODxET assay is interventional in nature as use of the assay impacts
the clinical management of patients whose specimens are screened using the
ODxET.
Intervention
The analysis using the ODxET assay is interventional in nature as use of the
assay impacts the clinical management of patients whose specimens are screened
using the ODxET.
Study burden and risks
The validated ODxE Test (used in this study as a clinical trial assay (CTA))
will be used for detection of IDH1 gene mutations as confirmation before
recruitment (molecular eligibility determination) for the CHONQUER study. The
ODxE Test CTA will be used to confirm IDH1 mutations for subjects with Grades
1-3 conventional chondrosarcoma.
A false negative result by the ODxET CTA may result in the patient not being
enrolled in the CHONQUER clinical trial, from which they may have derived
clinical benefit.
A false positive result by the ODxE Test CTA may result in an ineligible
patient being enrolled in the CHONQUER clinical trial, receiving treatment with
ivosidenib and thus being exposed to potential side-effects with reduced
likelihood of gaining clinical benefit.
Eligible patients for enrollment are populations with no approved or standard
systemic therapy specifically indicated for patients with conventional
chondrosarcoma. The potential benefits associated with the use of ivosidenib
therapy outweigh any risks of the validated ODxE Test assay to identify
eligible participants.
Kwartsweg 2
Bleiswijk 2665 NN
NL
Kwartsweg 2
Bleiswijk 2665 NN
NL
Listed location countries
Age
Inclusion criteria
Representativity of the target population for enrolment onto the clinical trial
is dictated by the CHONQUER clinical trial inclusion criteria and the selected
CHONQUER clinical trial sites.
Sample inclusion criteria for the ODxE Test:
• De-identified FFPE samples collected from patients being screened for
enrollment in the CHONQUER study.
• Sample(s) that meet the samples requirement criteria (tumor presence and
content specified in the clinical protocol
• Sample(s) that meet the minimum tissue input requirements specified in the
clinical protocol
• Sample(s) that meet the minimum nucleic acid concentration requirements per
ODxE Test User Guide.
Exclusion criteria
Representativity of the target population for enrolment onto the
ECUR-506-OTC-101 clinical trial is dictated by the CHONQUER clinical trial
exclusion criteria and the selected CHONQUER clinical trial sites
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL87400.000.24 |