Condition: Myelodysplastic Syndromes · Acute Myeloid Leukemia · Myelodysplastic Syndrome/Neoplasm · Sponsor: Taiho Oncology, Inc.
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 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 treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML. The duration of this multi-phase study is approximately 8 years.
This description comes directly from the study's public registry record.
Taiho Oncology, Inc. · +1 844-878-2446 · medicalinformation@taihooncology.com
Always discuss trial participation with your own doctor first.
| Keck School of Medicine of USC | Los Angeles, California, United States | Recruiting |
| UC Irvine Health - Chao Family Comprehensive Cancer Center | Orange, California, United States | Recruiting |
| Yale University | New Haven, Connecticut, United States | Recruiting |
| University of Miami - Sylvester Comprehensive Cancer Center | Miami, Florida, United States | Recruiting |
| University of Emory - Winship Cancer Institute | Atlanta, Georgia, United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| John Theurer Cancer Center / Hackensack University | Hackensack, New Jersey, United States | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo, New York, United States | Recruiting |
| New York University Langone Hospital - Long Island | Mineola, New York, United States | Recruiting |
| Perlmutter Cancer Center - 34th Street | New York, New York, United States | Recruiting |
| Icahn School of Medicine at Mount Sinai | New York, New York, United States | Recruiting |
| Weill Cornell Medical Center | New York, New York, United States | Withdrawn |
+ 59 more locations — full list on the registry record.
Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.
We email about this public record only. Unsubscribe anytime with one click. Never medical advice.
This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.
Source record: clinicaltrials.gov/study/NCT04256317