AG-120 in People With IDH1 Mutant Chondrosarcoma (NCT04278781) | Clinical Trial Compass
Active — Not RecruitingPhase 2
AG-120 in People With IDH1 Mutant Chondrosarcoma
United States6 participantsStarted 2020-03-04
Plain-language summary
This study is being done to see whether AG-120 is an effective and safe treatment for people with advanced/metastatic or recurrent chondrosarcoma that has IDH1 mutation.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Be \>/= 18 years of age
* Have a histological diagnosis (fresh or archived tumor biopsy sample) of locally advanced/metastatic or recurrent operable chondrosarcoma (conventional grade 2 or 3 only) confirmed by central pathology review
* Patients with low grade (grade 1) and dedifferentiated chondrosarcoma are ineligible
* Patients with biopsy proven low grade (grade 1) pelvic chondrosarcoma are ineligible unless they have radiological imaging consistent with higher grade disease in which case they will be deemed potentially eligible. In such cases the pre-treatment biopsy should be taken where feasible from the area of presumed higher-grade disease to confirm grade 2 or 3 disease to confirm eligibility
* Patients without confirmation of grade 2 or 3 disease will not be eligible for the study unless in the case where radiology features are consistent with high grade disease but a biopsy confirmation of this is not technically feasible. Such cases should be discussed with the principal investigator before enrollment onto the study
* Have a documented IDH1 gene mutation (from a fresh tumor biopsy or from archived tumor tissue) confirmed by a CLIA approved laboratory.
* Have an ECOG OS score of 0 to 2.
* Have expected survival of \>/= 4 months.
* Have at least one measurable lesion as defined by RECIST 1.1, subjected who have received prior local therapy are eligible provided the measurable disease falls outside of the treatment field or within the f…