OncoMatch/Clinical Trials/NCT02074839
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
Is NCT02074839 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies AG-120 for relapsed or refractory acute myeloid leukemia (aml).
Treatment: AG-120 — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Non-Hodgkin Lymphoma
Multiple Myeloma
Myelodysplastic Syndrome
Chronic Lymphocytic Leukemia
Biomarker criteria
Required: IDH1 r132 mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: hematopoietic stem cell transplant
Exception: HSCT >60 days prior to first dose, stable oral steroids/topical for skin GVHD permitted
Subjects who have undergone hematopoietic stem cell transplant (HSCT) within 60 days of the first dose of AG-120, or subjects on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). (The use of a stable dose of oral steroids post HSCT and/or topical for ongoing skin GVHD is permitted.)
Cannot have received: systemic anticancer therapy or radiotherapy
Exception: Hydroxyurea is allowed prior to enrollment and after the start of AG-120
Subjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed prior to enrollment and after the start of AG-120).
Cannot have received: investigational agent
Subjects who received an investigational agent <14 days prior to their first day of study drug administration.
Lab requirements
Blood counts
Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed)
Kidney function
serum creatinine ≤2.0 × ULN or creatinine clearance >40mL/min based on Cockroft-Gault GFR
Liver function
AST, ALT, and ALP ≤3.0 × ULN unless considered due to leukemic disease; serum total bilirubin ≤1.5 x ULN unless considered due to Gilbert's disease or leukemic disease
Cardiac function
NYHA Class III or IV CHF or LVEF <40% by ECHO or MUGA within ~28 days of C1D1 excluded; history of MI within last 6 months excluded; known unstable or uncontrolled angina pectoris excluded; severe/uncontrolled ventricular arrhythmias excluded; QTc interval ≥450 ms or other factors that increase risk of QT prolongation or arrhythmic events excluded
adequate hepatic function as evidenced by: AST, ALT, and ALP ≤3.0 × ULN, unless considered due to leukemic disease and serum total bilirubin ≤1.5 x ULN, unless considered due to Gilbert's disease or leukemic disease; adequate renal function as evidenced by a serum creatinine ≤2.0 × ULN or creatinine clearance >40mL/min based on Cockroft-Gault GFR; Platelet count ≥20,000/µL (Transfusions to achieve this level are allowed); NYHA Class III or IV CHF or LVEF <40% by ECHO or MUGA within ~28 days of C1D1 excluded; history of MI within last 6 months excluded; known unstable or uncontrolled angina pectoris excluded; severe/uncontrolled ventricular arrhythmias excluded; QTc interval ≥450 ms or other factors that increase risk of QT prolongation or arrhythmic events excluded
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham · Birmingham, Alabama
- Mayo Clinic-AZ · Phoenix, Arizona
- City of Hope · Duarte, California
- University of California-Los Angeles · Los Angeles, California
- University of California-San Francisco · San Francisco, California
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT02074839 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior hematopoietic stem cell transplant, systemic anticancer therapy or radiotherapy, investigational agent disqualifies patients from enrollment.
Does this trial require IDH1?
Yes, IDH1 r132 mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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