AG-120 in People With IDH1 Mutant Chondrosarcoma
Phase II Study of AG-120 in IDH1 Mutant Chondrosarcoma
1 other identifier
interventional
6
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Mar 2020
Longer than P75 for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2020
CompletedFirst Posted
Study publicly available on registry
February 20, 2020
CompletedStudy Start
First participant enrolled
March 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
April 23, 2026
April 1, 2026
7 years
February 18, 2020
April 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival
Progression free survival includes both disease progression (as defined by RECIST 1.1) and death from any cause
16 weeks
Study Arms (1)
Chondrosarcoma
EXPERIMENTALParticipants will have locally advanced/metastatic or recurrent operable chondrosarcoma
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
- Received a prior IDH1 inhibitor.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Johns Hopkins Hospital (Data Collection Only)
Baltimore, Maryland, 21287, United States
Columbia University (Specimen Analysis Only)
New York, New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
The Ohio State University (Data Collection Only)
Columbus, Ohio, 43210, United States
MD Anderson Cancer Center (Data Collection Only)
Houston, Texas, 77030, United States
Related Publications (1)
Ramsey DC. CORR Insights(R): Are IDH1 R132 Mutations Associated With Poor Prognosis in Patients With Chondrosarcoma of the Bone? Clin Orthop Relat Res. 2024 Jun 1;482(6):957-959. doi: 10.1097/CORR.0000000000003019. Epub 2024 Mar 6. No abstract available.
PMID: 38446419DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ciara M Kelly, MBBCh, BAO
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2020
First Posted
February 20, 2020
Study Start
March 4, 2020
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
April 23, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.