Actively Recruiting
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Led by Institut de Recherches Internationales Servier · Updated on 2025-06-08
291
Participants Needed
30
Research Sites
626 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
CONDITIONS
Official Title
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Documented IDH1 R132 gene-mutated advanced hematologic malignancy
- Able to undergo serial bone marrow biopsies, peripheral blood sampling, and urine sampling during the study
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Platelet count of at least 20,000/µL (transfusions allowed to reach this level)
- Adequate liver function with AST, ALT, and ALP less than or equal to 3 times the upper limit of normal unless due to leukemia, and total bilirubin less than or equal to 1.5 times the upper limit of normal unless due to Gilbert's disease or leukemia
- Adequate kidney function with serum creatinine less than or equal to 2 times the upper limit of normal or creatinine clearance greater than 40 mL/min
- Recovered from any significant side effects of prior cancer treatments
- Female participants with reproductive potential must have a negative pregnancy test within 7 days before starting study drug
You will not qualify if you...
- Hematopoietic stem cell transplant within 60 days before first dose or ongoing immunosuppressive therapy post-transplant, or clinically significant graft-versus-host disease (except stable oral steroids or topical treatment for skin GVHD)
- Received systemic anticancer therapy or radiotherapy less than 14 days before first dose (hydroxyurea allowed)
- Received an investigational agent less than 14 days before first dose
- Pregnant or breastfeeding
- Active severe infection or unexplained fever over 38.5°C at screening or first dose (tumor fever may be allowed)
- New York Heart Association Class III or IV heart failure or left ventricular ejection fraction less than 40% within 28 days before first dose
- History of heart attack within 6 months before screening
- Known unstable or uncontrolled angina or severe ventricular arrhythmias
- QT interval corrected for heart rate (QTc) of 450 ms or longer or other risk factors for arrhythmia
- Taking medications known to prolong QT interval
- Known infection with HIV or active hepatitis B or C
- Symptoms or diagnosis of active central nervous system leukemia
- Life-threatening severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, or disseminated intravascular coagulation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Active, Not Recruiting
2
Mayo Clinic-AZ
Phoenix, Arizona, United States, 85259
Terminated
3
City of Hope
Duarte, California, United States, 91010
Active, Not Recruiting
4
University of California-Los Angeles
Los Angeles, California, United States, 90095
Terminated
5
University of California-San Francisco
San Francisco, California, United States, 94143
Terminated
6
University of Colorado Denver
Aurora, Colorado, United States, 80045
Terminated
7
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Terminated
8
University of Miami
Miami, Florida, United States, 33136
Terminated
9
Moffit Cancer Center
Tampa, Florida, United States, 33612
Active, Not Recruiting
10
Emory University
Atlanta, Georgia, United States, 30322
Active, Not Recruiting
11
Northwestern University Medical Hospital
Chicago, Illinois, United States, 60611
Terminated
12
John Hopkins Cancer Center
Baltimore, Maryland, United States, 21287
Active, Not Recruiting
13
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Terminated
14
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Terminated
15
Karmanos Cancer Center
Detroit, Michigan, United States, 48201
Terminated
16
Washington University
St Louis, Missouri, United States, 63110
Terminated
17
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Active, Not Recruiting
18
Cornell Cancer Center
New York, New York, United States, 10065
Terminated
19
Duke Cancer Center
Durham, North Carolina, United States, 27705
Terminated
20
Cleveland Clinic
Cleveland, Ohio, United States, 44124
Withdrawn
21
Ohio State University
Columbus, Ohio, United States, 43210
Terminated
22
Oregon Health and Science University
Portland, Oregon, United States, 97239
Terminated
23
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
24
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Terminated
25
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
26
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
27
Hopital La Timone
Marseille, France
Terminated
28
Hopital Haut-Leveque
Pessac, France, 33600
Actively Recruiting
29
Central Lyon Sud
Pierre-Bénite, France, 69310
Actively Recruiting
30
Institute Gustave Roussly (IGR)
Villejuif, France, 94800
Actively Recruiting
Research Team
I
Institut de Recherches Internationales Servier Clinical Studies Department
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here