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IDH1 Inhibitor
AG-120 for Chondrosarcoma
Phase 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can take pills by mouth.
Select...
I am 18 years old or older.
Select...
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).
Select...
My cancer is not low grade or dedifferentiated chondrosarcoma.
Select...
My chondrosarcoma (grade 2 or 3) diagnosis is confirmed by a biopsy.
Select...
My cancer has a confirmed IDH1 mutation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 16 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression free survival
Side effects data
From 2021 Phase 3 trial • 187 Patients • NCT0298985728%
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%
Hypokalaemia
5%
Rash
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%
Electrocardiogram QT prolonged
2%
Chills
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
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
1,940 Previous Clinical Trials
588,875 Total Patients Enrolled
1 Trials studying Chondrosarcoma
180 Patients Enrolled for Chondrosarcoma
Agios Pharmaceuticals, Inc.Industry Sponsor
52 Previous Clinical Trials
4,189 Total Patients Enrolled
Ciara M Kelly, MBBCh, BAOPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart's pumping ability is below 40% as shown by recent tests.I haven't had radiotherapy or local treatment for cancer spread in the last 2 weeks.I have previously been treated with an IDH1 inhibitor.I do not have an active infection needing strong medication or unexplained high fever recently.I haven't had serious heart problems like heart failure, heart attack, or stroke in the last 6 months.I can switch or monitor my current sensitive medication before the study starts.I have brain metastases but am not currently on steroids and have been stable for 3 months.I am taking 10mg or less of prednisolone daily.I can take pills by mouth.I am not on QT-prolonging meds or can switch before the study.You are expected to live for at least four more months.I am not pregnant or have confirmed contraception use if capable of becoming pregnant.I have a tumor that can be measured and has grown by at least 20% after treatment.I do not have active hepatitis B or C, HIV, or AIDS, or my condition is well-managed.I haven't had cancer treatment or experimental drugs in the last 3 weeks.I have been diagnosed with progressive multifocal leukoencephalopathy.I have a grade 2 or 3 pelvic chondrosarcoma confirmed by biopsy.You are allergic to any part of AG-120.I have not had major surgery in the last 4 weeks or still have significant side effects from one.I am 18 years old or older.I am able to get out of my bed or chair and move around.My kidneys work well enough (creatinine clearance >= 50ml/min).My kidney function is normal.My kidney function is suitable for the trial based on a specific calculation.I am not on strong medication that affects liver enzyme activity, or I can switch if needed.I have a condition that affects how my stomach or intestines absorb medicine taken by mouth.I have recovered from side effects of previous cancer treatments.My heart's electrical activity or family history may increase my risk for irregular heartbeats.My liver is working well.My cancer is not low grade or dedifferentiated chondrosarcoma.My blood tests show my bone marrow is working well.My chondrosarcoma (grade 2 or 3) diagnosis is confirmed by a biopsy.My cancer has a confirmed IDH1 mutation.I can understand and agree to follow the study's requirements and sign the consent form.I have another cancer that needs treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Chondrosarcoma
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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