Pharmacokinetics, Safety, and Efficacy of ASTX727 in Combination With Venetoclax in Acute Myeloid Leukemia (AML)
Public ClinicalTrials.gov record NCT04657081. 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 Single-Arm, Open-Label Pharmacokinetic, Safety, and Efficacy Study of ASTX727 in Combination With Venetoclax in Adult Patients With Acute Myeloid Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The Phase 1 portion of this study is a single-arm, open-label, multicenter, non-randomized interventional study to evaluate the pharmacokinetic (PK) interaction, safety, and efficacy of ASTX727 when given in combination with venetoclax for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. The primary purpose of the study is to rule out drug-drug interactions between ASTX727 and venetoclax combination therapy by evaluating area under the curve (AUC) and maximum plasma concentration (Cmax) exposure. The Phase 2 portion of the study is to assess the efficacy of ASTX727 and venetoclax when given in combination and to evaluate potential PK interactions. Phase 2 will follow the same overall study design as Phase 1 and has two parts, Part A and Part B. Following study completion, participants who get clinical benefit without unnecessary risks may continue to receive study treatment in the study extension phase.
Study identification
- NCT ID
- NCT04657081
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 101 participants
Conditions and interventions
Conditions
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 8, 2021
- Primary completion
- Sep 29, 2024
- Completion
- Dec 30, 2026
- Last update posted
- Sep 15, 2026
2021 – 2026
United States locations
- U.S. sites
- 24
- U.S. states
- 15
- U.S. cities
- 23
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| Stanford University | Palo Alto | California | 94306 | — |
| Yale University | New Haven | Connecticut | 06510 | — |
| Baptist MD Anderson Cancer Center | Jacksonville | Florida | 32207 | — |
| Boca Raton Clinical Research | Plantation | Florida | 33322 | — |
| The University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Indiana University Simon Cancer Center | Indianapolis | Indiana | 46202 | — |
| Tufts Medical Center | Boston | Massachusetts | 02111 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Massachusetts, Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Health Midwest Ventures Group, Inc. | Kansas City | Missouri | 64132 | — |
| Hackensack University of Medical Center | Hackensack | New Jersey | 07601 | — |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | — |
| Weill Cornell Medical College | Ney York | New York | 10065 | — |
| University of Rochester | Rochester | New York | 14627 | — |
| The Research Foundation of the State University of New York (SUNY) | Syracuse | New York | 13210 | — |
| East Carolina University | Greenville | North Carolina | 27834 | — |
| The Ohio State University | Columbus | Ohio | 43210 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-6307 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| Baylor Scott & White Research Institute | Temple | Texas | 76508 | — |
| Seattle Cancer Care Alliance | 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 10 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04657081, 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 Sep 15, 2026 · Synced Sep 25, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04657081 live on ClinicalTrials.gov.