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

This study is currently recruiting participants.
Verified December 2017 by Agios Pharmaceuticals, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03173248
First Posted: June 1, 2017
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Agios Pharmaceuticals, Inc.
  Purpose
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.

Condition Intervention Phase
Newly Diagnosed Acute Myeloid Leukemia (AML) Untreated AML AML Arising From Myelodysplastic Syndrome (MDS) Leukemia, Myeloid, Acute Drug: AG-120 (ivosidenib) with Azacitidine Drug: Placebo with Azacitidine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Agios Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 12 Months, on average ]

Secondary Outcome Measures:
  • Event Free Survival (EFS) [ Time Frame: 8 Months, on average ]
  • Complete Remission Rate (CR Rate) [ Time Frame: 8 Months, on average ]
  • CR + CRh Rate [ Time Frame: 8 Months, on average ]
  • Objective Response Rate (ORR) [ Time Frame: 8 Months, on average ]

Estimated Enrollment: 392
Actual Study Start Date: June 20, 2017
Estimated Study Completion Date: June 2022
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AG-120 (ivosidenib) with Azacitidine Drug: AG-120 (ivosidenib) with Azacitidine
Continuous 28-day cycles of AG-120 (ivosidenib) 500 mg orally (PO) once daily (QD) in combination with azacitidine 75 mg/m2/day SC or IV for the first week of each cycle
Placebo Comparator: Placebo with Azacitidine Drug: Placebo with Azacitidine
Continuous 28-day cycles of Placebo orally (PO) once daily (QD) in combination with azacitidine 75 mg/m2/day SC or IV for the first week of each cycle

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be ≥ 18 years of age.
  2. Have previously untreated AML, defined according to WHO criteria, with ≥ 20% leukemic blasts in the bone marrow. Subjects with extramedullary disease alone (ie, 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 Performance Status 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 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. Subjects 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 subject 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 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 subject's ability to give informed consent or participate in the study.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173248


Contacts
Contact: Medical Affairs Agios Pharmaceuticals, Inc. (844) 633-2332 medinfo@agios.com

Locations
United States, California
City of Hope Recruiting
Duarte, California, United States, 91010
UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
United States, Illinois
University of Chicago Not yet recruiting
Chicago, Illinois, United States, 60637
Illinois Cancer Specialists Recruiting
Niles, Illinois, United States, 60714
United States, Indiana
Indiana Blood and Marrow Transplantation Recruiting
Indianapolis, Indiana, United States, 46237
United States, Kentucky
Norton Cancer Institute Recruiting
Louisville, Kentucky, United States, 40207
United States, Maryland
University of Maryland Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
United States, New Jersey
Hackensack University Medical Center - John Theurer Cancer Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Roswell Park Cancer Institute Not yet recruiting
Buffalo, New York, United States, 14263
Weill Cornell Medical College Not yet recruiting
New York, New York, United States, 10065
Stony Brook University Medical Center Recruiting
Stony Brook, New York, United States, 11794
New York Medical College Not yet recruiting
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27705
Brody School of Medicine at East Carolina University Recruiting
Greenville, North Carolina, United States, 27858
United States, Ohio
Gabrail Cancer Center Recruiting
Canton, Ohio, United States, 44718
Oncology Hematology Care, Inc. Recruiting
Cincinnati, Ohio, United States, 45242
United States, Oregon
Kaiser Permanente Recruiting
Portland, Oregon, United States, 97227
United States, South Carolina
Greenville Health System Cancer Institute Recruiting
Greenville, South Carolina, United States, 29615
United States, Texas
Baylor Research Institute Recruiting
Dallas, Texas, United States, 75246
Sponsors and Collaborators
Agios Pharmaceuticals, Inc.
  More Information

Responsible Party: Agios Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03173248     History of Changes
Other Study ID Numbers: AG120-C-009
First Submitted: May 30, 2017
First Posted: June 1, 2017
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Agios Pharmaceuticals, Inc.:
Acute Myeloid Leukemia
Leukemia
Azacitidine
AG-120
ivosidenib

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors