A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)

Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final f

Trial Details

NCT ID
NCT04256317
Phase
PHASE2 / PHASE3
Sponsor
Taiho Oncology, Inc.
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Azacitidine
  • ASTX030 (cedazuridine + azacitidine)
  • Cedazuridine
  • Venetoclax
Locations (sample)
  • Los Angeles, California, United States|34.05223,-118.24368
  • Orange, California, United States|33.78779,-117.85311
  • New Haven, Connecticut, United States|41.30815,-72.92816
  • Miami, Florida, United States|25.77427,-80.19366
  • Atlanta, Georgia, United States|33.749,-84.38798

Key Eligibility Criteria

  • Phase 2 Monotherapy:
  • 1\. Has Confirmed MDS, CMML, or other MDS/MPN diagnosis who are candidates to receive and benefit from single agent azacitidine and as applicable a…
  • Phase 3 Monotherapy:
  • Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approval…

For full eligibility, visit ClinicalTrials.gov.

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