Chondrosarcoma, Chondrosarcoma, Grade 2, Chondrosarcoma, Grade 3, IDH1 Gene Mutation
Conditions
Keywords
Chondrosarcoma, Chondrosarcoma, Grade 2, Chondrosarcoma, Grade 3, IDH1 Gene Mutation, IDH1 Mutant Chondrosarcoma, AG-120, locally advanced chondrosarcoma, metastatic chondrosarcoma, Memorial Sloan Kettering Cancer Center, 19-393
Brief 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.
Interventions
DRUGAG-120
AG-120 500 mg orally once daily days 1-28 of a 28-day cycle
Sponsors
Agios Pharmaceuticals, Inc.
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 field and has shown \>/=20% growth in size since post-treatment assessment. * Have documented radiographic disease progression within the preceding 4 months before study entry (date ICF signed). Have recovered from toxicities associated with prior anti-cancer therapy to baseline unless stabilized under medical management (see washout time from different therapies in
Exclusion criteria
section). * Have adequate bone marrow functions as evidenced by: * Absolute neutrophil count \>/=1,500/mm\^3 or 100 x 10\^9/L. * Hemoglobin \>/=8/dL. * Platelets \>/=100,000/mm\^3 or 100 x 10\^9/L. * Have adequate hepatic function as evidenced by: * Serum total bilirubin \</=2 x upper limit of normal (ULN), unless considered due to Gilbert's disease. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \</=5 x ULN. * Have adequate renal function as evidenced by: * Serum creatinine \<1.5 x ULN OR * creatinine clearance \>/= 50ml/min based on the cockcroft-gault glomerular filtration rate (GFR) estimation: * (140 Age) x (weight in kg) x (0.85 if female)/72 x serum creatinine * Be able to understand and willing to sign the informed consent form and to comply with scheduled visits, treatment plans, procedures and laboratory tests, including serial peripheral blood sampling and urine sampling, during the study. A legally authorized representative may consent on behalf of a subject who is otherwise unable to provide informed consent if acceptable to and approved by the site's Institutional Review Board (IRB) * Be able to swallow oral medication. * Female subjects with reproductive potential must have a negative serum or urine pregnancy test prior to the start of therapy, or a confirmation from an obstetrician in case of equivocal serum pregnancy results. Females of reproductive potential are defined as sexually mature women who have not undergone a hysterectomy, bilateral oophorectomy, or tubal occlusion or who have not been naturally postmenopausal (i.e., who have not menstruated) for at least 24 consecutive months (i.e., have not had menses at any time in the preceding 24 consecutive months). Women of reproductive potential, as well as fertile men and their partners who are female with reproductive potential, must agree to use 2 effective forms of contraception (including at least 1 barrier form) from the time of giving informed consent throughout the study and for 90 days (both females and males) following the last dose of study drug. Effective forms of contraception are defined as hormonal oral contraceptive, injectables, patches, intrauterine devices, intrauterine hormone-releasing systems bilateral tubal ligation, condoms with spermicide, or male partner sterilization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 16 weeks | Progression free survival includes both disease progression (as defined by RECIST 1.1) and death from any cause |
Countries
United States
Outcome results
None listed