Study of ASTX727 vs IV Decitabine in Participants With MDS, CMML, and AML
Public ClinicalTrials.gov record NCT03306264. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Open-Label, Crossover Study of ASTX727 (Cedazuridine and Decitabine Fixed-Dose Combination) Versus IV Decitabine in Subjects With Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), and Acute Myeloid Leukemia (AML)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Multicenter PK study of ASTX727 versus IV decitabine. Adult participants who were candidates to receive IV decitabine were randomized 1:1 to receive the ASTX727 tablet Daily×5 in Cycle 1 followed by IV decitabine 20 mg/m\^2 Daily×5 in Cycle 2, or the converse order. After completion of PK studies during the first 2 treatment cycles, participants continued to receive treatment with ASTX727 from Cycle 3 onward (in 28-day cycles) until disease progression, unacceptable toxicity, or the participants discontinued treatment or withdrew from the study.
Study identification
- NCT ID
- NCT03306264
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 227 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 15, 2018 (Actual)
- Primary completion
- Sep 10, 2021 (Actual)
- Completion
- May 25, 2023 (Actual)
- Last update posted
- Aug 27, 2024
2018 – 2023
United States locations
- U.S. sites
- 39
- U.S. states
- 22
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pinnacle Research Group | Anniston | Alabama | 36207 | — |
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Arizona Clinical Research Center | Tucson | Arizona | 85715 | — |
| Compassionate Cancer Care Research Group | Fountain Valley | California | 92708 | — |
| University of Southern California | Los Angeles | California | 90007 | — |
| Yale | New Haven | Connecticut | 06510 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| Boca Raton Clinical Research | Boca Raton | Florida | 33322 | — |
| Holy Cross Hospital | Fort Lauderdale | Florida | 33308 | — |
| Mount Sinai | Miami Beach | Florida | 33140 | — |
| Rush University Medical Center | Chicago | Illinois | 60612 | — |
| University of Chicago | Chicago | Illinois | 60637 | — |
| Quincy Medical Group | Quincy | Illinois | 62301 | — |
| Indiana Blood and Marrow Transplantation | Indianapolis | Indiana | 46237 | — |
| Norton Cancer Institute | Louisville | Kentucky | 40207 | — |
| Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Regional Cancer Care Associates | Bethesda | Maryland | 20817 | — |
| Michigan Center of Medical Research | Farmington Hills | Michigan | 48334 | — |
| Cancer & Hematology Centers of Western Michigan | Grand Rapids | Michigan | 49503 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | — |
| Hackensack | Hackensack | New Jersey | 07601 | — |
| Roswell Park | Buffalo | New York | 14263 | — |
| Monter Cancer Center | Lake Success | New York | 11042 | — |
| Weill Cornell Medicine | New York | New York | 10065 | — |
| Montefiore | The Bronx | New York | 10467 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Oregon Health & Sciences University | Portland | Oregon | 20817 | — |
| West Penn Allegheny Cancer Institute | Pittsburgh | Pennsylvania | 15224 | — |
| University of Pittsburgh Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Charleston Hematology Oncology Associates | Charleston | South Carolina | 29414 | — |
| Vanderbilt | Nashville | Tennessee | 37232 | — |
| Baylor Scott & White University Medical Center | Dallas | Texas | 75246 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390-9179 | — |
| Houston Methodist Cancer Center | Houston | Texas | 77030 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Utah Cancer Specialists | Salt Lake City | Utah | 84124 | — |
| Kadlec Clinic Hematology and Oncology | Kennewick | Washington | 99336 | — |
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 45 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03306264, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 27, 2024 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03306264 live on ClinicalTrials.gov.