Trial Profile

A Multi-phase, Pharmacokinetics, Safety, and Efficacy Study of ASTX030 (Azacitidine and Cedazuridine) as Monotherapy in Subjects With Myeloid Neoplasm or in Combination With Venetoclax in Subjects With AML (AZTOUND Study)

Status: Recruiting

Phase of Trial: Phase II/III

Latest Information Update: 25 Aug 2025

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At a glance

Drugs Azacitidine/cedazuridine (Primary) ; Azacitidine; Azacitidine; Cedazuridine
Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes; Myeloproliferative disorders
Focus Pharmacokinetics; Registrational
Acronyms AZTOUND
Sponsors Astex Pharmaceuticals; Taiho Oncology

07 Aug 2025 Planned number of patients changed from 235 to 236.
11 Feb 2025 Treatment arms changed from 6 to 4, patient number changed from 315 to 235, time frame of primary endpoint changed from 2 months to Predose and at multiple timepoints post-dose up to 24 hours.
11 Feb 2025 Planned number of patients changed from 317 to 235.

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