ClinicalTrials.gg
Active, not recruitingNCT04278781Updated Apr 23, 2026

AG-120 in People With IDH1 Mutant Chondrosarcoma

A Phase 2 interventional study of AG-120 in Chondrosarcoma, Chondrosarcoma, Grade 2 and Chondrosarcoma, Grade 3, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-23.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chondrosarcoma
  • Chondrosarcoma, Grade 2
  • Chondrosarcoma, Grade 3
  • IDH1 Gene Mutation

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
03

In context

Chondrosarcoma

99 studies on the registry are indexed under Chondrosarcoma; 20 are open to participants now.

This study's enrollment of 6 is below the median of 52 across 72 interventional studies indexed under Chondrosarcoma.

Browse Chondrosarcoma studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Be >/= 18 years of age
  • Have a histological diagnosis (fresh or archived tumor sample) of locally advanced/ 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 OS score of 0 to 2.
  • Have expected survival of >/= 4 months.
  • Have at least one as defined by 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:

    • >/=1,500/mm\^3 or 100 x 10\^9/L.
    • >/=8/dL.
    • >/=100,000/mm\^3 or 100 x 10\^9/L.
  • Have adequate hepatic function as evidenced by:

    • Serum total \</=2 x (ULN), unless considered due to Gilbert's disease.
    • (AST) and alanine aminotransferase (ALT) \</=5 x ULN.
  • Have adequate renal function as evidenced by:

    • Serum creatinine \<1.5 x ULN OR
    • >/= 50ml/min based on the cockcroft-gault (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 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 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 (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 (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.

Exclusion criteria

Exclusion Criteria:

  • Received a prior IDH1 inhibitor.
  • Received systemic anticancer therapy or an 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 sites of disease \<2 weeks prior to Day 1.
  • Underwent major surgery within 4 weeks of Day 1 or have not recovered from post-surgery toxicities.
  • Have known symptomatic requiring . 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,

  • Has another concurrent active cancer requiring therapeutic intervention.
  • Are pregnant or breastfeeding.
  • Are taking known strong 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 to any components of AG-120.
  • Have significant active cardiac disease within 6 months prior to the start of study treatment, including Class II or IV congestive heart failure: myocardial infraction: unstable angina; and/or stroke.
  • Have LVEP \<40% by ECHO and/or obtained within 28 days prior to the start of the study treatment.
  • Have a heart-rate 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 (HBV) or (HCV) infections, known positive (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)
Terms in these criteria, in plain language(29)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Reproductive potential

Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.

Criteria about it usually ask for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

CYP3A (CYP3A4) inhibitors and inducers

CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.

Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Chondrosarcoma

    Participants will have locally advanced/metastatic or recurrent operable chondrosarcoma

    Drug: AG-120

Interventions

  • DrugAG-120

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

06

What researchers measure

Primary outcomes

  1. Progression free survival

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

    Time frame: 16 weeks

07

Study locations

5 sites
08

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04278781
Responsible party
Sponsor
First posted
Feb 20, 2020
Start date
Mar 4, 2020
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Apr 23, 2026

Study contacts

Ciara M Kelly, MBBCh, BAO
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Ivosidenib

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