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Home » Find Clinical Trials » Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE)

Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation (AGILE)

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Servier Protocol Code: AG120-C-009 Sponsor: Institut de Recherches Internationales Servier Clinicaltrials.gov Identifier: NCT03173248 EudraCT Number: 2016-004907-30 EU Trial (CTIS) Number: 2024-514309-73-00

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How to participate in this study
If you think you are eligible for this study (see
eligibility criteria
below), you can identify the location closest to you and contact them directly. If you can’t find a location close to you, please contact Institut de Recherches Internationales Servier (I.R.I.S.)
Name: Institut de Recherches Internationales Servier, Département des études cliniques
Phone number: +33 1 55 72 60 00
The study has 90 locations

Study description

The study is needed to test if AG-120 (study drug) is an effective and safe treatment when combined with another drug called azacitidine, used to treat patients with acute myeloid leukaemia (AML). AML is a type of cancer of the blood and bone marrow.

In 6 to 10% of cases of AML, an abnormal form of a protein called isocitrate dehydrogenase 1 (IDH1) is present in the cancer cells due to changes called mutations. When IDH1 is present in this abnormal form, it produces too much 2-hydroxyglutarate (2-HG). This impairs normal cell functioning and may cause cells to become cancer cells.

AG-120 is a drug that blocks the activity of abnormal IDH1 proteins and thus may reduce 2-HG levels in cancer cells to normal levels. It has already been approved in several countries to treat AML and bile duct cancer in patients with IDH1 mutation.

In this study, AG-120 is combined with azacitidine which blocks the growth of cancer cells. Azacitidine has been approved in several countries. It is recommended for patients with AML who cannot receive strong chemotherapy, called intensive chemotherapy.

The main goal of this study is to test how well AG-120 in combination with azacitidine works compared to placebo with azacitidine, in patients who have AML with changes in the IDH1 gene. A placebo looks like AG-120 but does not contain any real medicine.

Official title: A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of AG-120 in Combination With Azacitidine in Subjects ≥ 18 Years of Age With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
Conditions
Newly Diagnosed Acute Myeloid Leukemia (AML) Untreated AML AML Arising From Myelodysplastic Syndrome (MDS) Leukemia, Myeloid, Acute
Interventions / Treatments
  • AG-120
  • Placebo
  • Azacitidine
Other study id numbers
  • AG120-C-009

Eligibility Criteria

Eligible age for the study

18 years and older (Adult, Older Adult)

Sex

Male/Female

Accepts Healthy Volunteers

No

To take part in the study, participants have to:

  • Be at least 18 years old.
  • Have previously untreated AML.
  • Have cancer cells with changes in the IDH1 gene.
  • Be too frail for intensive chemotherapy.

Participants cannot take part in the study if they:

  • Have previously received a drug that blocks IDH1.
  • Have received treatment for their AML.

How is the study designed?

Allocation
Randomized
Interventional study model
Parallel
Participant Group / Arm
Experimental: AG-120 + Azacitidine

Participants take AG-120 (500 miligrams) orally every day, over 28-day cycles. They also receive azacitidine into a vein or under the skin for 7 days, over the same 28-day cycles.

Intervention / Treatment
Drug: AG-120
Drug: Azacitidine
Participant Group / Arm
Placebo Comparator: Placebo + Azacitidine

Participants take placebo orally every day, over 28 day-cycles. They also receive azacitidine into a vein or under the skin for 7 days, over the same 28 day-cycles.

Intervention / Treatment
Drug: Placebo
Drug: Azacitidine

Keywords

Provided by Servier
Acute Myeloid Leukemia Leukemia Azacitidine AG-120 ivosidenib
Additional Relevant MeSH Terms Glioma
Leukemia, Myeloid, Acute Leukemia