Clinical trial
Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in…
NCT03173248 · Institut de Recherches Internationales Servier, Other · Active, not recruiting
Key facts
| NCT number | NCT03173248 |
|---|---|
| Title | Study of AG-120 (Ivosidenib) vs. Placebo in Combination With Azacitidine in Participants With Previously Untreated Acute Myeloid Leukemia With an IDH1 Mutation |
| 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 |
| Acronym | AGILE |
| Lead sponsor | Institut de Recherches Internationales Servier, Other |
| Status | Active, not recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute |
| Intervention type | Drug |
| Interventions | AG-120, Placebo, Azacitidine |
| Enrollment | 146 |
| Start date | Jun 26, 2017 |
| Primary completion | Mar 18, 2021 |
| Completion | Jun 30, 2026 |
| First posted | Jun 1, 2017 |
| Last update posted | Nov 10, 2025 |
| Countries | Australia, Austria, Brazil, Canada, China, Czechia, France, Germany, Israel, Italy, Japan, Mexico and 8 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: