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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    200
  • sponsor
    Agios Pharmaceuticals, Inc.
Updated on 12 May 2021
Investigator
Medical Affairs Agios Pharmaceuticals, Inc.
Primary Contact
Salzburger Landeskliniken (0.0 mi away) Contact
+234 other location
remission
carbon monoxide
induction chemotherapy
azacitidine
blast cells

Summary

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.

Details
Condition Acute myeloid leukemia, Acute Myelogenous Leukemia (AML), Untreated AML, Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS), Newly Diagnosed Acute Myeloid Leukemia (AML), AML Arising From Myelodysplastic Syndrome (MDS)
Treatment AG-120 (ivosidenib) with Azacitidine, Placebo with Azacitidine
Clinical Study IdentifierNCT03173248
SponsorAgios Pharmaceuticals, Inc.
Last Modified on12 May 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Be 18 years of age and meet at least 1 of the following criteria defining ineligibility for intensive induction chemotherapy (IC): 75 years old, Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 2, severe cardiac disorder (eg, congestive heart failure requiring treatment, LVEF, 50%, or chronic stable angina), severe pulmonary disorder (eg, diffusing capacity of the lungs for carbon monoxide 65% or forced expiratory volume in 1 second 65%), creatinine clearance <45 mL/minute, bilirubin >1.5 times the upper limit of normal ( ULN) and/or have any other comorbidity that the Investigator judges to be incompatible with intensive IC and must be reviewed and approved by the Medical Monitor before study enrollment
Have previously untreated AML, defined according to World Health Organization (WHO) criteria, with 20% leukemic blasts in the bone marrow. Participants with extramedullary disease alone (ie, no detectable bone marrow and no detectable peripheral blood AML) are not eligible for the study
Have an isocitrate dehydrogenase 1 (IDH1) mutation
Have an ECOG PS score of 0 to 2
Have adequate hepatic function
Have adequate renal function
Have agreed to undergo serial blood and bone marrow sampling
Be able to understand and willing to sign an informed consent form (ICF)
Be willing to complete Quality of Life assessments during the study
If female with reproductive potential, must have a negative serum pregnancy test prior to the start of study therapy. Females of reproductive potential, as well as fertile men and their female partners of reproductive potential, must agree to use 2 effective forms of contraception

Exclusion Criteria

Are candidates for and willing to receive intensive induction chemotherapy (IC) for their AML
Have received any prior treatment for AML with the exception of hydroxyurea
Have received a hypomethylating agent for myelodysplastic syndrome (MDS)
Participants who had previously received an experimental agent for MDS may not be randomized until a washout period has elapsed since the last dose of that agent
Have received prior treatment with an IDH1 inhibitor
Have a known hypersensitivity to any of the components of AG-120, matched placebo, or azacitidine
Are female and pregnant or breastfeeding
Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment
Have a prior history of cancer other than MDS or myeloproliferative disorder, unless the participant has been free of the disease for 1 year prior to the start of study treatment
Have had significant active cardiac disease within 6 months prior to the start of the study treatment
Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia
Have a condition that limits the ingestion or absorption of drugs administered by mouth
Have uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg)
Have clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia
Have immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation
Have any other medical or psychological condition deemed by the Investigator to be likely to interfere with the participant's ability to give informed consent or participate in the study
Are taking medications that are known to prolong the QT interval unless they can be transferred to other medications within 5 half-lives prior to dosing, or unless the medications can be properly monitored during the study. (If equivalent medication is not available, heart rate corrected QT interval [QTc] will be closely monitored.)
Have a known medical history of progressive multifocal leukoencephalopathy
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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