NCT03173248ACTIVE_NOT_RECRUITINGanonymous

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

Sponsor

Source record

Institut de Recherches Internationales Servier

Phase

Source record

Phase 3

Modality

AI-normalized

small molecule

Target

AI-normalized

Isocitrate dehydrogenase 1 (IDH1) mutation

Indication / condition

AI-normalized

Newly Diagnosed Acute Myeloid Leukemia (AML)

Intervention

Source record

AG-120, Placebo, Azacitidine

Source & freshness

Source record

NCT ID

NCT03173248

Original source

ClinicalTrials.gov

Source last updated

Nov 10, 2025

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record

View original source fields

NCT ID

NCT03173248

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

Sponsor

Institut de Recherches Internationales Servier

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 3

Condition raw

Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute

Condition normalized

Newly Diagnosed Acute Myeloid Leukemia (AML), Untreated AML, AML Arising From Myelodysplastic Syndrome (MDS), Leukemia, Myeloid, Acute

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Isocitrate dehydrogenase 1 (IDH1) mutation

Target normalized

Isocitrate dehydrogenase 1 (IDH1) mutation

Interventions

AG-120, Placebo, Azacitidine

Public preview

Source record

AG-120 (ivosidenib) is being evaluated in combination with azacitidine for the treatment of previously untreated acute myeloid leukemia (AML) with an IDH1 mutation. This combination therapy targets a specific patient population that is not suitable for intensive chemotherapy, potentially expanding the market for IDH1 inhibitors in AML treatment. The global AML market is projected to grow significantly, driven by advancements in targeted therapies. Competitive landscape includes other IDH inhibitors and hypomethylating agents, necessitating careful monitoring of clinical outcomes and market positioning. Diligence should focus on the trial's efficacy and safety data, as well as regulatory pathways for approval.

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TrialSignal

Clinical trial intelligence report

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

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT03173248

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 3

Sponsor

Institut de Recherches Internationales Servier

Executive brief

Investment-Ready Snapshot

Source & freshness

Provenance

SourceClinicalTrials.gov

Source updatedNov 10, 2025

Internal syncJun 12, 2026

Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT03173248

Indication

Newly Diagnosed Acute Myeloid Leukemia (AML)

Modality

small molecule

Target

Isocitrate dehydrogenase 1 (IDH1) mutation

Intervention

AG-120, Placebo, Azacitidine

Source record