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Last Updated: November 21, 2019

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CLINICAL TRIALS PROFILE FOR IVOSIDENIB

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All Clinical Trials for Ivosidenib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03071770 Japanese Bridging Study of Ivosidenib (AG-120) in Healthy Subjects Active, not recruiting Agios Pharmaceuticals, Inc. Phase 1 2017-03-31 The purpose of this Phase I, single-dose, open-label trial is to evaluate the pharmacokinetics and safety of ivosidenib (AG-120) in healthy, adult male Japanese and Caucasian subjects. The study plans to evaluate 3 cohorts of a single oral dose of ivosidenib (AG-120) in Japanese and Caucasian subjects. Pharmacokinetic sampling will take place serially through-out the duration of subject participation.
NCT03173248 Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation Not yet recruiting Agios Pharmaceuticals, Inc. Phase 3 2017-06-01 Study AG120-C-009 is a global, Phase 3, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of AG-120 (ivosidenib) + azacitidine vs placebo + azacitidine in adult subjects with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is Overall Survival (OS). The key secondary efficacy endpoints are Event free Survival (EFS), rate of complete remission (CR), Rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Subjects eligible for study treatment based on Screening assessments will be randomized 1:1 to receive oral AG-120 or matched placebo, both administered in combination with subcutaneous (SC) or intravenous (IV) azacitidine. An estimated 392 subjects will participate in the study.
NCT03282513 A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function Not yet recruiting Agios Pharmaceuticals, Inc. Phase 1 2017-09-01 Study AG120-C-012 is a Phase 1, open-label, single-dose study designed to evaluate the PK, safety, and tolerability of a single 500 mg AG-120 (Ivosidenib) dose in subjects with mild or moderate hepatic impairment (HI) compared to subjects with normal hepatic function. The study will be conducted at 2 US centers.
NCT03471260 Study of Venetoclax With the mIDH1 Inhibitor Ivosidenib (AG120) in IDH1-Mutated Hematologic Malignancies Recruiting AbbVie Phase 1/Phase 2 2018-03-19 There are 2 parts to this clinical research study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of the combination of ivosidenib (AG-120) and venetoclax that can be given to patients with relapsed (has come back) or refractory (has not responded to treatment) acute myeloid leukemia (AML) with an IDH1 mutation (a type of genetic change). The goal of Part 2 is to learn if the highest tolerable dose of ivosidenib and venetoclax found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts. This is an investigational study. Ivosidenib is not FDA approved or commercially available. Venetoclax is FDA approved and commercially available for the treatment of a certain type of chronic lymphocytic leukemia (CLL). It is considered investigational to use ivosidenib in combination with venetoclax to treat AML. The study doctor can explain how the study drugs are designed to work. Up to 48 patients will be enrolled on this study. All will take part at MD Anderson.
NCT03471260 Study of Venetoclax With the mIDH1 Inhibitor Ivosidenib (AG120) in IDH1-Mutated Hematologic Malignancies Recruiting Agios Pharmaceuticals, Inc. Phase 1/Phase 2 2018-03-19 There are 2 parts to this clinical research study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of the combination of ivosidenib (AG-120) and venetoclax that can be given to patients with relapsed (has come back) or refractory (has not responded to treatment) acute myeloid leukemia (AML) with an IDH1 mutation (a type of genetic change). The goal of Part 2 is to learn if the highest tolerable dose of ivosidenib and venetoclax found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts. This is an investigational study. Ivosidenib is not FDA approved or commercially available. Venetoclax is FDA approved and commercially available for the treatment of a certain type of chronic lymphocytic leukemia (CLL). It is considered investigational to use ivosidenib in combination with venetoclax to treat AML. The study doctor can explain how the study drugs are designed to work. Up to 48 patients will be enrolled on this study. All will take part at MD Anderson.
NCT03471260 Study of Venetoclax With the mIDH1 Inhibitor Ivosidenib (AG120) in IDH1-Mutated Hematologic Malignancies Recruiting M.D. Anderson Cancer Center Phase 1/Phase 2 2018-03-19 There are 2 parts to this clinical research study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of the combination of ivosidenib (AG-120) and venetoclax that can be given to patients with relapsed (has come back) or refractory (has not responded to treatment) acute myeloid leukemia (AML) with an IDH1 mutation (a type of genetic change). The goal of Part 2 is to learn if the highest tolerable dose of ivosidenib and venetoclax found in Part 1 can help to control the disease. The safety of this drug combination will be studied in both parts. This is an investigational study. Ivosidenib is not FDA approved or commercially available. Venetoclax is FDA approved and commercially available for the treatment of a certain type of chronic lymphocytic leukemia (CLL). It is considered investigational to use ivosidenib in combination with venetoclax to treat AML. The study doctor can explain how the study drugs are designed to work. Up to 48 patients will be enrolled on this study. All will take part at MD Anderson.
NCT03564821 IDH1 Inhibition Using Ivosidenib as Maintenance Therapy for IDH1-mutant Myeloid Neoplasms Following Allogeneic Stem Cell Transplantation Not yet recruiting Agios Pharmaceuticals, Inc. Phase 1 2018-10-31 This research study is studying a drug as a possible treatment for IDH1-mutant myeloid neoplasms. -The drug involved in this study is ivosidenib (AG-120)
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ivosidenib

Condition Name

Condition Name for Ivosidenib
Intervention Trials
Acute Myeloid Leukemia 3
IDH1 NP_005887.2:p.R132L 1
AML Arising From Myelodysplastic Syndrome (MDS) 1
Newly Diagnosed Acute Myeloid Leukemia (AML) 1
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Condition MeSH

Condition MeSH for Ivosidenib
Intervention Trials
Leukemia, Myeloid, Acute 4
Leukemia, Myeloid 3
Preleukemia 3
Myelodysplastic Syndromes 3
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Clinical Trial Locations for Ivosidenib

Trials by Country

Trials by Country for Ivosidenib
Location Trials
United States 8
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Trials by US State

Trials by US State for Ivosidenib
Location Trials
Minnesota 2
Wisconsin 1
Pennsylvania 1
Massachusetts 1
Texas 1
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Clinical Trial Progress for Ivosidenib

Clinical Trial Phase

Clinical Trial Phase for Ivosidenib
Clinical Trial Phase Trials
Phase 3 2
Phase 2 2
Phase 1/Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Ivosidenib
Clinical Trial Phase Trials
Not yet recruiting 7
Recruiting 1
Active, not recruiting 1
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Clinical Trial Sponsors for Ivosidenib

Sponsor Name

Sponsor Name for Ivosidenib
Sponsor Trials
Agios Pharmaceuticals, Inc. 6
AbbVie 1
Bristol-Myers Squibb (BMS) 1
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Sponsor Type

Sponsor Type for Ivosidenib
Sponsor Trials
Other 8
Industry 7
NIH 1
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