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IDH1 Inhibitor

AG-120 for Chondrosarcoma

Phase 2
Waitlist Available
Led By Ciara M Kelly, MBBCh, BAO
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be able to swallow oral medication.
Be >/= 18 years of age
Must not have
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.
Received radiotherapy or other local intervention to metastatic sites of disease <2 weeks prior to Day 1.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing AG-120, to see if it is safe and effective in people with chondrosarcoma that has returned or spread, and has an IDH1 mutation.

Who is the study for?
This trial is for adults with advanced or recurrent chondrosarcoma and an IDH1 gene mutation. Participants must have stable vital organ functions, no severe infections, not be pregnant or breastfeeding, agree to use two forms of contraception if they can reproduce, and not have used certain other treatments recently.
What is being tested?
The study tests AG-120's effectiveness and safety in treating chondrosarcoma with the IDH1 mutation. It examines how well patients respond to this oral medication when their cancer has returned or spread despite previous treatment.
What are the potential side effects?
While specific side effects of AG-120 are not listed here, common ones may include digestive issues, fatigue, liver problems (elevated enzymes), blood disorders (like changes in white and red cell counts), skin reactions, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take pills by mouth.
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My kidneys work well enough (creatinine clearance >= 50ml/min).
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My cancer is not low grade or dedifferentiated chondrosarcoma.
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My chondrosarcoma (grade 2 or 3) diagnosis is confirmed by a biopsy.
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My cancer has a confirmed IDH1 mutation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have brain metastases but am not currently on steroids and have been stable for 3 months.
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I haven't had radiotherapy or local treatment for cancer spread in the last 2 weeks.
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I have previously been treated with an IDH1 inhibitor.
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I haven't had serious heart problems like heart failure, heart attack, or stroke in the last 6 months.
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I have been diagnosed with progressive multifocal leukoencephalopathy.
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I have not had major surgery in the last 4 weeks or still have significant side effects from one.
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I have a condition that affects how my stomach or intestines absorb medicine taken by mouth.
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I have another cancer that needs treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression free survival

Side effects data

From 2021 Phase 3 trial • 187 Patients • NCT02989857
28%
Nausea
28%
Diarrhoea
23%
Fatigue
21%
Oedema peripheral
16%
Abdominal pain
16%
Anaemia
14%
Decreased appetite
14%
Weight decreased
12%
Vomiting
12%
Asthenia
12%
Cough
12%
Ascites
12%
Constipation
12%
Arthralgia
9%
Hypertension
9%
Abdominal pain upper
9%
Dizziness
9%
Muscle spasms
9%
Muscular weakness
9%
Dyspnoea
9%
Blood alkaline phosphatase increased
7%
Upper respiratory tract infection
7%
Hypoalbuminaemia
7%
Pruritus
7%
Hypophosphataemia
7%
Aspartate aminotransferase increased
7%
Alanine aminotransferase increased
7%
Insomnia
7%
Abdominal discomfort
5%
Rash
5%
Hypokalaemia
5%
Back pain
5%
White blood cell count decreased
5%
Hyperglycaemia
5%
Hyperkalaemia
5%
Pyrexia
5%
Headache
5%
Abdominal distension
5%
Blood bilirubin increased
5%
Confusional state
5%
Platelet count decreased
2%
Chills
2%
Electrocardiogram QT prolonged
2%
Cholangitis
2%
Gastrointestinal haemorrhage
2%
Intestinal pseudo-obstruction
2%
Biliary obstruction
2%
Bacteraemia
2%
Clostridium difficile colitis
2%
Escherichia bacteraemia
2%
Hip fracture
2%
Hypercalcaemia
2%
Encephalopathy
2%
Acute kidney injury
2%
Hypotension
2%
Gastrooesophageal reflux disease
2%
Hypomagnesaemia
2%
Blood creatinine increased
2%
Dyspepsia
2%
Urinary tract infection
2%
Rash maculo-papular
2%
Dry mouth
2%
Multiple sclerosis relapse
2%
Spinal cord compression
2%
Syncope
2%
Hyponatraemia
2%
Hepatic cirrhosis
2%
Oesophageal varices haemorrhage
2%
Upper gastrointestinal haemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
After Cross Over to AG-120
AG-120
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: ChondrosarcomaExperimental Treatment1 Intervention
Participants will have locally advanced/metastatic or recurrent operable chondrosarcoma
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AG-120
2017
Completed Phase 3
~370

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,969 Previous Clinical Trials
597,406 Total Patients Enrolled
1 Trials studying Chondrosarcoma
300 Patients Enrolled for Chondrosarcoma
Agios Pharmaceuticals, Inc.Industry Sponsor
53 Previous Clinical Trials
4,175 Total Patients Enrolled
Ciara M Kelly, MBBCh, BAOPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

AG-120 (IDH1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04278781 — Phase 2
Chondrosarcoma Research Study Groups: Chondrosarcoma
Chondrosarcoma Clinical Trial 2023: AG-120 Highlights & Side Effects. Trial Name: NCT04278781 — Phase 2
AG-120 (IDH1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278781 — Phase 2
~1 spots leftby Mar 2026
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