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ChondrosarcomaPhase 2NCT04278781

AG-120 in People With IDH1 Mutant Chondrosarcoma

A Phase 2 study testing AG-120 in people with Chondrosarcoma and Chondrosarcoma, Grade 2, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AG-120
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
5 sitesUnited States
Study dates
4 Mar 2020to Mar 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • Received a prior IDH1 inhibitor.
  • Received systemic anticancer therapy or an investigational agent < 3 week prior to the Day 1 (washout from prior immune based anticancer therapy is 4 weeks).
  • Received radiotherapy or other local intervention to metastatic sites of disease <2 weeks prior to Day 1.
  • Underwent major surgery within 4 weeks of Day 1 or have not recovered from clinically significant post-surgery toxicities.
  • Have known symptomatic brain metastasis requiring steroids. Subject with previously diagnosed brain metastases are eligible if they completed their treatment and have recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 4 weeks and have a radiographically stable disease for a least 3 months prior to study entry.
  • Note: up to 10mg per day of prednisolone or equivalent will be allowed,
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  • Has another concurrent active cancer requiring therapeutic intervention.
  • Are pregnant or breastfeeding.
  • Are taking known strong CYP3A4 inducers or sensitive CYP3A4 substrate medications with a narrow therapeutic window unless they can be transferred to other medication within >/=5 half-lives prior to dosing
  • Are taking p-glycoprotein (P-gp) transporter-sensitive substrate medications with a narrow therapeutic window, unless they can be transferred to other medications within >/= half-lives prior to dosing, or unless the medications can be properly monitored during the study.
  • Have an active infection requiring systemic anti-infective therapy or with an unexplained fever > 38.5 degrees C within 7 days of Day 1 (at the discretion of the investigator, subjects with tumor fever may be enrolled).
  • Have any known hypersensitivity to any components of AG-120.
  • Have significant active cardiac disease within 6 months prior to the start of study treatment, including New York Heart Association Class II or IV congestive heart failure: myocardial infraction: unstable angina; and/or stroke.
  • Have LVEP <40% by ECHO and/or MUGA scan obtained within 28 days prior to the start of the study treatment.
  • Have a heart-rate corrected QT interval [using Frederica's Formula] (QTcF) >/=450msec or other factor that increase the risk of QT prolongation or arrhythmic events (e.g., heart failure, hypokalemia, family history of long QT interval syndrome). Bundle branch block and prolonged QTcF interval are permitted with approval of the principal investigator.
  • Are taking medications known to prolong the QT interval, unless they can have transferred to other medications within >/= half-lives prior to dosing, or unless the medications can be properly monitored during the study (If equivalent medication is not available, QTcF should be closely monitored).
  • Have known active hepatitis B (HBV) or hepatitis C (HCV) infections, known positive human immunodeficiency virus (HIV) antibody results, or acquired immunodeficiency syndrome (AIDS) related illness. Subjects with a sustained viral response to HCV or immunity to prior HBV infection will be permitted. Subjects with chronic HBV that is adequately suppressed per institutional practice will be permitted.
  • Have any other acute or chronic medical or psychiatric condition, including recent or active suicidal ideation or behavior, or a laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  • Have known active inflammatory gastrointestinal disease, previous gastric resection, or lap band dysphagia, short bowel syndrome, gastroparesis or other conditions that limit ingestion or gastrointestinal absorption of drugs administered orally.
  • Has a known medical history of progressive multifocal leukoencephalopathy (PML)

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Johns Hopkins Hospital (Data Collection Only)

    Baltimore, Maryland, 21287

  • The Ohio State University (Data Collection Only)

    Columbus, Ohio, 43210

  • MD Anderson Cancer Center (Data Collection Only)

    Houston, Texas, 77030

  • Columbia University (Specimen Analysis Only)

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

Other trials in United States

About this study

Official title: Phase II Study of AG-120 in IDH1 Mutant Chondrosarcoma

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.

Being tested
AG-120
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
Medical subject headings
Chondrosarcoma, Lymphoma, Follicular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AG-120Drug

    AG-120 500 mg orally once daily days 1-28 of a 28-day cycle

Study groups in NCT04278781
Study groupRoleWhat they receive
ChondrosarcomaExperimentalParticipants will have locally advanced/metastatic or recurrent operable chondrosarcoma
Receives: Drug: AG-120

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival

    Progression free survival includes both disease progression (as defined by RECIST 1.1) and death from any cause

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start4 Mar 2020
  3. Primary completionMar 2027 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278781
Sponsor's protocol ID
19-393
Status last verified
Apr 2026
First submitted
18 Feb 2020
Last updated
23 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 38446419

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AG-120 in people with Chondrosarcoma and Chondrosarcoma, Grade 2, run by Memorial Sloan Kettering Cancer Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (time frame: 16 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04278781, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.

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