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

Active:	Yes
Cancer Type:	Cancer-Related Syndrome Leukemia Myelodysplastic Syndromes (MDS)	NCT ID:	NCT04256317
Trial Phases:	Phase II Phase III	Protocol IDs:	ASTX030-01 (primary) NCI-2020-03248 2024-515098-93
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Taiho Pharmaceutical Company Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT04256317

Summary

Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms and a
Phase 1 Combination Therapy arm 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 fixed dose of
oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label,
multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in
combination with venetoclax in participants with AML.

The duration of this multi-phase study is approximately 7 years.

Objectives

The Phase 1 and Phase 2 Monotherapy arms have completed enrolment. The Phase 3
Monotherapy and Phase 1 Combination Therapy arms are open for enrolment.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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