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Last Updated: June 26, 2022

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 Completed 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 Active, not recruiting Agios Pharmaceuticals, Inc. Phase 3 2017-06-26 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 participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants 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 200 participants will take part in the study.
NCT03173248 ↗ Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Patients With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation Active, not recruiting Institut de Recherches Internationales Servier Phase 3 2017-06-26 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 participants with previously untreated IDH1m AML who are considered appropriate candidates for non-intensive therapy. The primary endpoint is event-free survival (EFS). The key secondary efficacy endpoints are overall survival (OS), rate of complete remission (CR), rate of CR and complete remission with partial hematologic recovery (CRh), and overall response rate (ORR). Participants 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 200 participants will take part in the study.
NCT03282513 ↗ A Study of AG-120 (Ivosidenib) in Subjects With Mild or Moderate Hepatic Impairment or Normal Hepatic Function Completed Agios Pharmaceuticals, Inc. Phase 1 2017-09-26 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 ↗ Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies Recruiting AbbVie Phase 1/Phase 2 2018-03-19 This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.
NCT03471260 ↗ Ivosidenib and Venetoclax With or Without Azacitidine in Treating Patients With IDH1 Mutated Hematologic Malignancies Recruiting Agios Pharmaceuticals, Inc. Phase 1/Phase 2 2018-03-19 This phase Ib/II trial studies the side effects and best dose of venetoclax and how well it works when given together with ivosidenib with or without azacitidine, in treating patients with IDH1-mutated hematologic malignancies. Venetoclax and ivosidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ivosidenib and venetoclax with azacitidine may work better in treating patients with hematologic malignancies compared to ivosidenib and venetoclax alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ivosidenib

Condition Name

Condition Name for Ivosidenib
Intervention Trials
Acute Myeloid Leukemia 7
Recurrent Acute Myeloid Leukemia 5
Refractory Acute Myeloid Leukemia 4
Myeloproliferative Neoplasm 3
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Condition MeSH

Condition MeSH for Ivosidenib
Intervention Trials
Leukemia, Myeloid, Acute 11
Leukemia, Myeloid 10
Leukemia 10
Myelodysplastic Syndromes 6
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Clinical Trial Locations for Ivosidenib

Trials by Country

Trials by Country for Ivosidenib
Location Trials
United States 80
Spain 13
Italy 10
Japan 9
Brazil 9
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Trials by US State

Trials by US State for Ivosidenib
Location Trials
Texas 6
Ohio 6
Minnesota 4
New York 3
Massachusetts 3
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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 7
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Ivosidenib
Clinical Trial Phase Trials
Recruiting 8
Not yet recruiting 7
Active, not recruiting 3
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Clinical Trial Sponsors for Ivosidenib

Sponsor Name

Sponsor Name for Ivosidenib
Sponsor Trials
Agios Pharmaceuticals, Inc. 7
National Cancer Institute (NCI) 6
M.D. Anderson Cancer Center 4
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Sponsor Type

Sponsor Type for Ivosidenib
Sponsor Trials
Other 22
Industry 11
NIH 6
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