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Recruiting Phase 1 Interventional

Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

ClinicalTrials.gov ID: NCT02074839

Public ClinicalTrials.gov record NCT02074839. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 3:54 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase I, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT02074839
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 1
Enrollment
291 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2014
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026
Last update posted
Jun 14, 2026

2014 – 2026

United States locations

U.S. sites
26
U.S. states
18
U.S. cities
24
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35294 Active, not recruiting
Mayo Clinic-AZ Phoenix Arizona 85259 Terminated
City of Hope Duarte California 91010 Active, not recruiting
University of California-Los Angeles Los Angeles California 90095 Terminated
University of California-San Francisco San Francisco California 94143 Terminated
University of Colorado Denver Aurora Colorado 80045 Terminated
Mayo Clinic-Jacksonville Jacksonville Florida 32224 Terminated
University of Miami Miami Florida 33136 Terminated
Moffit Cancer Center Tampa Florida 33612 Active, not recruiting
Emory University Atlanta Georgia 30322 Active, not recruiting
Northwestern University Medical Hospital Chicago Illinois 60611 Terminated
John Hopkins Cancer Center Baltimore Maryland 21287 Active, not recruiting
Massachusetts General Hospital Boston Massachusetts 02214 Terminated
Dana Farber Cancer Institute Boston Massachusetts 02215 Terminated
Karmanos Cancer Center Detroit Michigan 48201 Terminated
Washington University St Louis Missouri 63110 Terminated
Memorial Sloan Kettering Cancer Center New York New York 10021 Active, not recruiting
Cornell Cancer Center New York New York 10065 Terminated
Duke Cancer Center Durham North Carolina 27705 Terminated
Cleveland Clinic Cleveland Ohio 44124 Withdrawn
Ohio State University Columbus Ohio 43210 Terminated
Oregon Health and Science University Portland Oregon 97239 Terminated
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
Sarah Cannon Research Institute Nashville Tennessee 37203 Terminated
UT Southwestern Medical Center Dallas Texas 75390 Recruiting
MD Anderson Cancer Center Houston Texas 77030 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02074839, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 14, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02074839 live on ClinicalTrials.gov.

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