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

November 4, 2025 updated by: Institut de Recherches Internationales Servier

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
  • Austria
      • Salzburg, Austria, 5020
        • Salzburger Landeskliniken
      • Vienna, Austria, 1130
        • Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
  • Brazil
      • Rio de Janeiro, Brazil, 20230-130
        • Instituto Nacional de Câncer
      • São Paulo, Brazil, 01308-050
        • Hospital Sírio Libanês
      • São Paulo, Brazil, 08270-070
        • Hospital Santa Marcelina
      • São Paulo, Brazil, 01321-001
        • Hospital São José
    • São Paulo
      • Campinas, São Paulo, Brazil, 13083-878
        • Unicamp Universidade Estadual de Campinas
      • Jaú, São Paulo, Brazil, 17210-120
        • Hospital Amaral Carvalho
  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0V9
        • Cancer Care Manitoba
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network
  • China
      • Beijing, China
        • Peking Union Medical College Hospital
      • Guangzhou, China, 510080
        • Guangdong Provincial People's Hospital
      • Hangzhou, China, 310003
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
      • Tianjin, China, 300020
        • Institute of Hematology and Blood Diseases Hospital Chinese Academy of Medical Sciences
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital Sichuan University
  • Czechia
      • Ostrava, Czechia
        • Fakultni Nemocnice Ostrava
  • France
      • Brest, France, 29609
        • CHRU de Brest - Hopital Morvan
      • Caen, France, 14000
        • Institut dHematologie de Basse Normandie
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Le Chesnay, France, 78 157
        • Centre Hospitalier de Versailles CHV Hopital Andre Mignot
      • Paris, France, 75015
        • Groupe Hospitalier Necker Enfants Malades
      • Poitiers, France, 86021
        • CHRU de Poitiers La Miletrie
      • Strasbourg, France, 67200
        • Hopital de Hautepierre
      • Toulouse, France, 31059
        • EDOG - Institut Claudius Regaud - PPDS
      • Villejuif, France, 94805
        • Institut Gustave Roussy
    • Gironde
      • Pessac, Gironde, France, 33604
        • Hopital Haut Leveque
    • Indre-et-Loire
      • Tours, Indre-et-Loire, France, 37044
        • Hopital Bretonneau
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44093
        • Hotel Dieu - Nantes
    • Rhone
      • Pierre-Bénite, Rhone, France, 69495
        • Centre Hospitalier Lyon Sud
    • Sarthe
      • Le Mans, Sarthe, France, 72037
        • Centre Hospitalier Le Mans
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • München, Germany, 81377
        • LMU Klinikum der Universität München
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm
    • North Rhine-Westphalia
      • Essen, North Rhine-Westphalia, Germany, 45122
        • Universitätsklinikum Essen
    • Saxony
      • Chemnitz, Saxony, Germany, 09113
        • Klinikum Chemnitz gGmbH
  • Israel
      • Petah Tikva, Israel, 49100
        • Rabin Medical Center - PPDS
      • Rehovot, Israel, 7610000
        • Kaplan Medical Center
      • Tzrifin, Israel, 70300
        • Shamir Medical Center Assaf Harofeh
  • Italy
      • Meldola, Italy, 47014
        • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS
      • Milan, Italy, 20162
        • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda
      • Milan, Italy, 20132
        • Ospedale San Raffaele S.r.l. - PPDS
      • Pavia, Italy, 27100
        • Fondazione IRCCS Policlinico San Matteo di Pavia
      • Rimini, Italy, 47900
        • Ospedale Infermi di Rimini
      • Torino, Italy, 10126
        • Azienda Ospedaliera Città della Salute e della Scienza di Torino
    • Lombardy
      • Varese, Lombardy, Italy, 21100
        • ASST dei Sette Laghi - Ospedale Di Circolo E Fondazione Macchi
  • Japan
      • Fukui, Japan, 910-1193
        • University of Fukui Hospital
      • Himeji, Japan, 670-8540
        • Japanese Red Cross Society Himeji Hospital
      • Kobe, Japan
        • Kobe City Medical Center General Hospital
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
        • Matsuyama Red Cross Hospital
  • Mexico
      • Culiacán, Mexico, 80230
        • SINACOR
      • México, Mexico, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Netherlands
      • Nijmegen, Netherlands, 6525 GA
        • Universitair Medisch Centrum Groningen
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1081 HV
        • VU Medisch Centrum
  • Poland
      • Gdansk, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 50-367
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-776
        • Instytut Hematologii I Transfuzjologii
  • Russia
      • Kaluga, Russia, 248007
        • Kaluga Regional Clinical Hospital
      • Moscow, Russia, 129301
        • City Clinical Hospital # 40
  • South Korea
      • Busan, South Korea, 602-739
        • Pusan National University Hospital
      • Seoul, South Korea, 03722
        • Severance Hospital Yonsei University Health System
      • Seoul, South Korea, 110-744
        • Seoul National University Hospital
    • Gyeonggido
      • Goyang-si, Gyeonggido, South Korea, 10408
        • National Cancer Center
      • Suwon, Gyeonggido, South Korea, 16499
        • Ajou University Hospital
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic De Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron - PPDS
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Spain, 28040
        • Hospital Universitario Fundacion Jimenez Diaz
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocio - PPDS
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe de Valencia
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • CHUS H. Clinico U. de Santiago
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spain, 07010
        • Hospital Universitario Son Espases
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Universitario Germans Trias i Pujol
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Doctor Negrín
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Medical Foundation Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Tainan, Taiwan, 736
        • Chi Mei Medical Center, Liouying
      • Taipei, Taiwan
        • National Taiwan University Hospital
  • United Kingdom
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Norton Cancer Institute - Suburban
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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 (e.g., congestive heart failure requiring treatment, left ventricular ejection fraction (LVEF), ≤50%, or chronic stable angina), severe pulmonary disorder (e.g., 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.
  2. 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 (i.e., no detectable bone marrow and no detectable peripheral blood AML) are not eligible for the study.
  3. Have an isocitrate dehydrogenase 1 (IDH1) mutation.
  4. Have an ECOG PS score of 0 to 2.
  5. Have adequate hepatic function.
  6. Have adequate renal function.
  7. Have agreed to undergo serial blood and bone marrow sampling.
  8. Be able to understand and willing to sign an informed consent form (ICF).
  9. Be willing to complete Quality of Life assessments during the study
  10. 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:

  1. Are candidates for and willing to receive intensive induction chemotherapy (IC) for their AML.
  2. Have received any prior treatment for AML with the exception of hydroxyurea.
  3. Have received a hypomethylating agent for myelodysplastic syndrome (MDS).
  4. 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.
  5. Have received prior treatment with an IDH1 inhibitor.
  6. Have a known hypersensitivity to any of the components of AG-120, matched placebo, or azacitidine.
  7. Are female and pregnant or breastfeeding.
  8. Have an active, uncontrolled, systemic fungal, bacterial, or viral infection without improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment.
  9. 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.
  10. Have had significant active cardiac disease within 6 months prior to the start of the study treatment.
  11. Have any condition that increases the risk of abnormal ECG or cardiac arrhythmia.
  12. Have a condition that limits the ingestion or absorption of drugs administered by mouth.
  13. Have uncontrolled hypertension (systolic blood pressure [BP] > 180 mmHg or diastolic BP > 100 mmHg).
  14. Have clinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia.
  15. Have immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
  16. 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.
  17. 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.)
  18. Have a known medical history of progressive multifocal leukoencephalopathy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AG-120 + Azacitidine
Participants received AG-120 500 mg orally, once daily (QD) in combination with azacitidine 75 milligrams per square meter per day (mg/m^2/day) subcutaneously (SC) or intravenously (IV), on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation.
Drug: AG-120
Tablets administered orally
Other Names:
  • Ivosidenib
Drug: Azacitidine
Administered SC or IV
Other Names:
  • Vidaza®
Placebo Comparator: Placebo + Azacitidine
Participants received AG-120 matching placebo orally, QD in combination with azacitidine 75 mg/m^2/day SC or IV, on Days 1-7, or on Days 1-5 and 8-9, of each 28-day cycle for a minimum of 6 cycles until death, disease relapse, disease progression, development of unacceptable toxicity (adverse event), confirmed pregnancy, withdrawal by participant or protocol violation .
Drug: Placebo
Tablets administered orally
Drug: Azacitidine
Administered SC or IV
Other Names:
  • Vidaza®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Event-Free Survival (EFS)
Time Frame: Up to Week 24
EFS was defined as the time from randomization until treatment failure, relapse from remission, or death from any cause, whichever occurs first. Treatment failure was defined as failure to achieve complete remission (CR) by Week 24. CR: Bone marrow blasts <5% and no Auer rods; absence of extramedullary disease; Absolute neutrophil count (ANC) ≥1.0 × 10^9 per litre (10^9/L) (1000 per microlitre [1000/μL]); platelet count ≥100 × 10^9/L (100,000/μL); independence of red blood cell transfusions. Participants who had an EFS event (relapse or death) after, 2 or more missing disease assessments were censored at the last adequate disease assessment documenting no relapse before the missing assessments. The reported data represents the Kaplan-Meier median value.
Up to Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Remission Rate (CR Rate)
Time Frame: Up to approximately 52 months
CR rate is defined as the proportion of participants who achieve a CR. A Cochran-Mantel-Haenszel (CMH) test will be used to compare CR rate between the 2 treatment arms.
Up to approximately 52 months
Overall Survival (OS)
Time Frame: Up to approximately 52 months
OS is defined as the time from date of randomization to the date of death due to any cause. Kaplan-Meier (KM) curves and KM estimates of OS will be presented for each treatment arm.
Up to approximately 52 months
CR + Complete Remission With Partial Hematologic (CRh) Rate
Time Frame: Up to approximately 52 months
CR + CRh rate is defined as the proportion of participants who achieve a CR or CRh. CRh is defined as a CR with partial recovery of peripheral blood counts (less than 5% bone marrow blasts, absolute neutrophil count (ANC) greater than 0.5 × 10^9/liter (L) 500/microliter (μL)], and platelets greater than 50 × 10^9/L [50,000/μL]). A CMH test will be used to compare the CR + CRh rate between the 2 treatment arms.
Up to approximately 52 months
Objective Response Rate (ORR)
Time Frame: Up to approximately 52 months
ORR is defined as the rate of CR, CR with incomplete hematologic recovery (CRi) (including CR with incomplete platelet recovery [CRp]), partial remission (PR), and morphologic leukemia-free state (MLFS). The best response is calculated using the following hierarchy: CR, followed by CRi (including CRp), followed by PR and MLFS. A summary of best response by treatment arm will be produced. A CMH test will be used to compare ORR between the 2 treatment arms.
Up to approximately 52 months
CR + CRi (Including CRp) Rate
Time Frame: Up to approximately 52 months
The CR + CRi (including CRp) rate is defined as the proportion of participants who achieve a CR or CRi (including CRp). A CMH test will be used to compare the CR + CRi (including CRp) rate between the 2 treatment arms.
Up to approximately 52 months
Duration of CR (DOCR)
Time Frame: Up to approximately 52 months
DOCR will be calculated as the date of the first occurrence of CR to the date of first documented disease relapse, or death. DOCR is only defined for participants who achieve a CR.
Up to approximately 52 months
Duration of CRh (DOCRh)
Time Frame: Up to approximately 52 months
DOCRh will be calculated as the date of the first occurrence of CR or CRh to the date of first documented disease relapse or death. DOCRh is only defined for participants who achieve a CR or CRh.
Up to approximately 52 months
Duration of Response (DOR)
Time Frame: Up to approximately 52 months
DOR will be calculated as the date of the first response to the date of first documented disease relapse, disease progression, or death. DOR is only defined for participants who achieve a CR, CRi (including CRp), PR, and/or MLFS.
Up to approximately 52 months
Duration of CRi (DOCRi)
Time Frame: Up to approximately 52 months
DOCRi will be calculated as the date of the first occurrence of CR or CRi (including CRp) to the date of the first documented relapse or death. DOCRi is only defined for participants who achieve a CR or CRi (including CRp).
Up to approximately 52 months
Time to CR (TTCR)
Time Frame: Up to approximately 52 months
TTCR will be assessed from the date of randomization to the date of first occurrence of CR. TTCR is only defined for participants who achieve a CR.
Up to approximately 52 months
Time to CRh (TTCRh)
Time Frame: Up to approximately 52 months
TTCRh will be assessed from the date of randomization to the date of first occurrence of CR or CRh. TTCRh is only defined for participants who achieve a CR or CRh.
Up to approximately 52 months
Time to Response (TTR)
Time Frame: Up to approximately 52 months
TTR will be assessed from the date of randomization to the date of the first response. TTR is only defined for participants who achieve a CR, CRi (including CRp), PR, and/or MLFS.
Up to approximately 52 months
Time to CRi (TTCRi)
Time Frame: Up to approximately 52 months
TTCRi will be assessed from the date of randomization to the date of first occurrence of CR or CRi (including CRp). TTCRi is only defined for participants who achieve a CR or CRi (including CRp).
Up to approximately 52 months
Units of Platelets and Red Blood Cells (RBC) Infused
Time Frame: Up to approximately 52 months
All measures that are indicative of clinical benefit are measured like number of units of platelet and RBC infused.
Up to approximately 52 months
Rate of Infection
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Percentage of Participants With CR With IDH1 Mutation Clearance (MC)
Time Frame: Up to approximately 52 months
CR with IDH1 MC is defined as a response of CR where there is no evidence of the IDH1 mutation by molecular techniques to below the level of detection (0.02%-0.04%) for ≥1 on-treatment time point. A CMH test will be used to compare the rate of CR between 2 treatment arms.
Up to approximately 52 months
Percentage of Participants With Abnormalities in Vital Sign Measurements
Time Frame: Up to approximately 52 months
Vital signs will include body temperature, respiratory rate, blood pressure, and heart rate.
Up to approximately 52 months
Percentage of Participants With Abnormalities in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Percentage of Participants With Abnormalities in 12-lead Electrocardiograms (ECGs)
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Percentage of Participants With Abnormalities in Echocardiogram (ECHO) or Multi-Gated Acquisition (MUGA) for Left Ventricular Ejection Fraction (LVEF)
Time Frame: Up to approximately 52 months
LVEF is determined by ECHO or MUGA scan in participants.
Up to approximately 52 months
Percentage of Participants With Abnormalities in Clinical Laboratory Tests
Time Frame: Up to approximately 52 months
Clinical laboratory assessments will include hematology, serum chemistry, coagulation.
Up to approximately 52 months
Percentage of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 52 months
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Up to approximately 52 months
Percentage of Participants With AEs of Special Interest (AESIs)
Time Frame: Up to approximately 52 months
AESIs are AEs that are not solicited local or systemic AEs, they are predefined AEs that required close monitoring and prompt reporting to the sponsor. AESIs include protocol-specified QT prolongation, isocitrate dehydrogenase (IDH) differentiation syndrome and leukocytosis.
Up to approximately 52 months
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Up to approximately 52 months
An SAE is defined as an untoward medical occurrence, significant hazard, contraindication, side effect or precaution that at any dose: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Up to approximately 52 months
Percentage of Participants With Adverse Events Leading to Discontinuation or Death
Time Frame: Up to approximately 52 months
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medicinal product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug.
Up to approximately 52 months
Percentage of Participants Using Concomitant Medications
Time Frame: Up to approximately 52 months
Participants receiving concomitant medications will be adequately monitored by ECG controls, drug concentration (where applicable), and serum electrolytes (i.e., potassium and magnesium).
Up to approximately 52 months
Number of Days Spent Hospitalized
Time Frame: Up to approximately 52 months
Up to approximately 52 months
Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) QLC-C30 Questionnaire
Time Frame: Up to approximately 52 months
The EORTC QLQ-C30 questionnaire measures quality of life and consists of 30 questions that are incorporated into 5 functional domains (physical, role, cognitive, emotional, and social); a global health status/global quality of life; 3 symptom scales (fatigue, pain, and nausea and vomiting); and 6 single items that assess additional symptoms (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea) and the perceived financial burden of treatment experienced by participants with cancer.
Up to approximately 52 months
Change From Baseline in the EORTC EQ-5D-5L Questionnaire
Time Frame: Up to approximately 52 months
The EORTC EQ-5D-5L questionnaire measures quality of life and spans 5 dimensions, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, which are used to build a composite of the participant's health status.
Up to approximately 52 months
Percentage of Participants With Drug Exposure, Dose Modifications and Dose Intensities
Time Frame: Up to approximately 52 months
The number of doses administered, total dose, duration of treatment, dose intensity, and the proportion of participants with dose modifications, will be summarized by treatment arm.
Up to approximately 52 months
Circulating Plasma Concentration of AG-120
Time Frame: Up to approximately 52 months
Serial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations.
Up to approximately 52 months
Circulating Plasma Concentration of 2-HG
Time Frame: Up to approximately 52 months
Serial blood samples will be drawn before and after dosing of study treatment in order to determine circulating plasma concentrations.
Up to approximately 52 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut de Recherches Internationales Servier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 18, 2021

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AG120-C-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified scientific and medical researchers can request access to anonymized patient-level and study-level clinical trial data.

Access can be requested for all interventional clinical studies:

  • used for Marketing Authorization (MA) of medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US).
  • where Servier is the Marketing Authorization Holder (MAH). The date of the first MA of the new medicine (or the new indication) in one of the EEA Member States will be considered for this scope.

In addition, access can be requested for all interventional clinical studies in patients:

  • sponsored by Servier
  • with a first patient enrolled as of 1 January 2004 onwards
  • for New Chemical Entity or New Biological Entity (new pharmaceutical form excluded) for which development has been terminated before any Marketing authorization (MA) approval.

IPD Sharing Time Frame

After Marketing Authorisation in EEA or US if the study is used for the approval.

IPD Sharing Access Criteria

Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Study Data/Documents

  1. Individual Participant Data Set
  2. Study Protocol
  3. Statistical Analysis Plan
  4. Informed Consent Form
  5. Clinical Study Report
  6. Study-level clinical trial data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Leukemia, Myeloid, Acute

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings