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Last Updated: April 9, 2025

CLINICAL TRIALS PROFILE FOR AG-120


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Clinical Trials for AG-120

Trial IDTitleStatusSponsorPhaseSummary
NCT02073994 ↗ Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation Active, not recruiting Agios Pharmaceuticals, Inc. Phase 1 The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, 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 arms of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or at Investigator discretion.
NCT02073994 ↗ Study of Orally Administered AG-120 in Subjects With Advanced Solid Tumors, Including Glioma, With an IDH1 Mutation Active, not recruiting Institut de Recherches Internationales Servier Phase 1 The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced solid tumors, including glioma, 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 arms of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Anticipated time on study treatment is until disease progression, unacceptable toxicity occurs or at Investigator discretion.
NCT02074839 ↗ Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation Recruiting Agios Pharmaceuticals, Inc. Phase 1 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.
NCT02074839 ↗ Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation Recruiting Institut de Recherches Internationales Servier Phase 1 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.
NCT02489513 ↗ Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-AG-120 Completed Agios Pharmaceuticals, Inc. Phase 1 The study is designed to characterize the absorption, metabolism, and excretion of AG-120 using radiolabeled drug in healthy adult male subjects to support its further development and registration.
NCT02579707 ↗ Food Effect Study of AG120 in Healthy Subjects Completed Agios Pharmaceuticals, Inc. Phase 1 This will be a 2-part study. PART 1 is an open-label, randomized, food effect study of AG-120. Subjects will be enrolled to a fed/fasted or fasted/fed treatment sequence in a 2-period crossover design. PART 2 is an open-label study to determine the safety and PK parameters of a single 1000-mg oral dose of AG-120.
NCT02632708 ↗ Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation Active, not recruiting Celgene Corporation Phase 1 The purpose of this Phase I, multicenter, clinical trial is to evaluate the safety of AG-120 and AG-221 when given in combination with standard AML induction and consolidation therapy. The study plans to evaluate up to 2 dose levels of AG-120 in participants with an isocitrate dehydrogenase protein 1 (IDH1) mutation and up to 2 dose levels of AG-221 in participants with an isocitrate dehydrogenase protein 2 (IDH2) mutation. AG-120 or AG-221 will be administered with 2 types of AML induction therapies (cytarabine with either daunorubicin or idarubicin) and 2 types of AML consolidation therapies (mitoxantrone with etoposide [ME] or cytarabine). After consolidation therapy, participants may continue on to maintenance therapy and receive daily treatment with single-agent AG-120 or AG-221 until relapse, development of an unacceptable toxicity, or hematopoietic stem cell transplant (HSCT). The study will end when all participants have discontinued study treatment.
>Trial ID>Title>Status>Phase>Summary
Showing 1 to 7 of 7 entries

Clinical Trial Conditions for AG-120

Condition Name

85430012345678Acute Myeloid LeukemiaRecurrent Acute Myeloid LeukemiaRefractory Acute Myeloid LeukemiaUntreated AML[disabled in preview]
Condition Name
Intervention Trials
Acute Myeloid Leukemia 8
Recurrent Acute Myeloid Leukemia 5
Refractory Acute Myeloid Leukemia 4
Untreated AML 3
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Condition MeSH

151312900246810121416Leukemia, Myeloid, AcuteLeukemia, MyeloidLeukemiaMyelodysplastic Syndromes[disabled in preview]
Condition MeSH
Intervention Trials
Leukemia, Myeloid, Acute 15
Leukemia, Myeloid 13
Leukemia 12
Myelodysplastic Syndromes 9
[disabled in preview] 0
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Clinical Trial Locations for AG-120

Trials by Country

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Trials by Country
Location Trials
United States 163
France 13
Spain 10
Japan 8
Germany 8
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Trials by US State

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Trials by US State
Location Trials
Texas 14
California 11
New York 10
Massachusetts 9
Ohio 8
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Clinical Trial Progress for AG-120

Clinical Trial Phase

10.7%25.0%14.3%50.0%023456789101112131415Phase 3Phase 2Phase 1/Phase 2[disabled in preview]
Clinical Trial Phase
Clinical Trial Phase Trials
Phase 3 3
Phase 2 7
Phase 1/Phase 2 4
[disabled in preview] 14
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Clinical Trial Status

39.3%21.4%21.4%17.9%0567891011RecruitingCompletedActive, not recruiting[disabled in preview]
Clinical Trial Status
Clinical Trial Phase Trials
Recruiting 11
Completed 6
Active, not recruiting 6
[disabled in preview] 5
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Clinical Trial Sponsors for AG-120

Sponsor Name

trials0246810121416Agios Pharmaceuticals, Inc.National Cancer Institute (NCI)Institut de Recherches Internationales Servier[disabled in preview]
Sponsor Name
Sponsor Trials
Agios Pharmaceuticals, Inc. 15
National Cancer Institute (NCI) 6
Institut de Recherches Internationales Servier 5
[disabled in preview] 8
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Sponsor Type

49.0%39.2%11.8%00510152025OtherIndustryNIH[disabled in preview]
Sponsor Type
Sponsor Trials
Other 25
Industry 20
NIH 6
[disabled in preview] 0
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