IDH1 mutation IDH1 mutation
Conditions
Interventions
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. The design ensures that ODx
Sponsors
Life Technologies Corporation, part of Thermo Fisher Scientific
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: Participants who consent to take part in the associated CHONQUER trial. Clinical trial samples will only be tested if participants have signed the ICF allowing for use of their samples. De-identified FFPE samples collected from participants being screened for enrollment in the CHONQUER study. Participants with banked tumor tissue available or able to provide freshly collected tumor tissue if banked samples are unavailable. Sample(s) that meet the sample requirement criteria (tumor presence and content specified in CPSP Table 4). Sample(s) that meet the minimum tissue input requirements (appropriate number of slides per biopsy type as specified in CPSP Table 5). Sample(s) that meet the minimum nucleic acid concentration requirements per ODxET User Guide
Exclusion criteria
Exclusion criteria: Sample that do not meet the ODxET inclusion criteria outlined above will not be utilized in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical performance study endpoint is to demonstrate that the ODxE test is safe and effective for identifying participants eligible for ivosidenib treatment in the Phase 3 clinical trial CL3-95031-007 (CHONQUER trial). This will be supported by efficacy data from the trial, including progression-free survival (PFS) assessed by blinded independent central review (BICR) and by the investigator and overall survival (OS) in both Grade 1 and Grade 2 participants, as well as OS in all randomized patients. These efficacy measures will establish the clinical utility of the ODxE test as a potential companion diagnostic (CDx) for ivosidenib. | — |
Countries
Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, Italy, Japan, Netherlands, South Korea, Spain, Taiwan, United Kingdom, United States
Contacts
Public ContactNhan Viet
Life Technologies Corporation, part of Thermo Fisher Scientific
Outcome results
None listed