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AG-120 for Blood Cancers
Study Summary
This trial is testing a new drug, AG-120, to see if it's safe and effective in treating people with advanced cancers that have a mutation in the IDH1 gene. The trial has two parts: first, they'll test different doses of the drug to see what the maximum tolerated dose is; then, they'll expand the trial to a larger group of people to see if the drug is effective. There's also a substudy testing AG-120 in people with a different but related cancer, myelodysplastic syndrome.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 3 trial • 187 Patients • NCT02989857Trial Design
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Who is running the clinical trial?
Media Library
- I haven't had cancer treatment or radiotherapy in the last 14 days, except for hydroxyurea.I do not have a severe infection or unexplained fever over 38.5°C.I have severe heart failure or my heart's pumping ability is less than 40%.I have a history of severe heart rhythm problems.My platelet count is at least 20,000/µL, transfusions included.My blood cancer has a specific IDH1 R132 gene mutation.I am willing to undergo repeated bone marrow biopsies, blood, and urine tests.I had a heart attack in the last 6 months.I have unstable or uncontrolled chest pain.I am a woman who can have children and have a recent negative pregnancy test.I am taking medication that affects my heart's rhythm.I do not have HIV or active hepatitis B or C.I might have leukemia in my brain or spinal cord.I am experiencing severe, life-threatening complications from leukemia.I can take care of myself and am up and about more than half of my waking hours.I am 18 years old or older.My liver functions, including AST, ALT, and ALP levels, are within normal limits.My kidney function is within the required range.I have recovered from side effects of my previous cancer treatments.I had a stem cell transplant less than 60 days ago, or I am on immunosuppressants, or I have significant GVHD.I have unstable or uncontrolled chest pain.My heart's electrical activity (QTc interval) is normal or I don't have factors that risk abnormal heart rhythms.
- Group 1: AG-120
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
Has AG-120 obtained the requisite authorization from the FDA?
"Due to the limited efficacy and safety data collected thus far, AG-120 was given a score of 1 on our team's scale. This rating is reflective of the fact that this trial is in its earliest stages."
Is this study currently enrolling new participants?
"Per clinicaltrials.gov, this medical trial is still accepting participants following its initial posting on March 1st 2014 and most recent edit on September 12th 2022."
How many individuals are being registered for the clinical experiment?
"To satisfy the standards of this trial, 291 participants must be enrolled. These individuals can join from a range of medical centres such as UT Southwestern Medical Center in Baltimore, Maryland and University of Miami in Atlanta, Georgia."
What is the geographic scope of this trial's implementation?
"This ongoing medical study is currently held at 21 sites, including Baltimore, Atlanta and Jacksonville. To maximise convenience for participants, it may be beneficial to select the closest location available when enrolling in this trial."
What other experiments have utilized AG-120 in their research?
"AG-120 was initially tested in a clinical trial labelled NCT02073994 back in 2014. This has been followed by 6 completed studies, with currently 21 recruiting trials being conducted, the most of which are based out of Baltimore, Maryland."
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