A Multi-phase, Dose-Escalation Followed by an Open-label, Randomized, Crossover Study of Oral ASTX030 (Cedazuridine and Azacitidine Given in Combination) Versus Subcutaneous Azacitidine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)
Latest Information Update: 06 Mar 2025
At a glance
- Drugs Azacitidine/cedazuridine (Primary) ; Azacitidine; Azacitidine; Cedazuridine
- Indications Acute myeloid leukaemia; Chronic myelomonocytic leukaemia; Myelodysplastic syndromes; Myeloproliferative disorders
- Focus Pharmacokinetics; Registrational
- Sponsors Astex Pharmaceuticals; Taiho Oncology
- 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.
- 11 Feb 2025 Planned End Date changed from 1 Apr 2026 to 1 May 2028.