Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Pre… (NCT03173248) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation
United States, Australia146 participantsStarted 2017-06-26
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (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.
✓. 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.
✓. 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.
What they're measuring
1
Event-Free Survival (EFS)
Timeframe: Up to Week 24
Trial details
NCT IDNCT03173248
SponsorInstitut de Recherches Internationales Servier
. Be able to understand and willing to sign an informed consent form (ICF).
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.