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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 (Agios AG120-C-009)
Overall Recruitment Status: Enrollment on-hold
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 (Agios AG120-C-009)
Region Sponsors
Agios Pharmaceuticals, Inc.
Acronym KP IRB No.
Study Type Phase
Clinical Trial Phase III
Study Population Description
Newly Diagnosed Acute Myeloid Leukemia (AML); Untreated AML; AML Arising From Myelodysplastic Syndrome (MDS); Leukemia, Myeloid, Acute;
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.
Detailed Description
Gender Age Limit
Male & Female
Inclusion Criteria
  • Be >/= 18 years of age.
  • 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.
  • Have an isocitrate dehydrogenase 1 (IDH1) mutation
  • Have an ECOG Performance Status 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 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).
  • 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.
  • 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 subject 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 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.
  • Please contact study personnel for more eligibility information

Keywords and/or Specific Medical Conditions
  • Acute Myeloid Leukemia
  • Oncology (Adult)
  • Leukemia
KP Clinical Facility
  • Central Interstate Medical Office
  • Sunnyside Medical Center
Clinical Area
  • Oncology (Adult)

Principal Investigator:
Abdul Hai Mansoor, MD
Contact Information:
- Rhonda Stephenson, RN
-Central Interstate Medical Office

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