A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes
Public ClinicalTrials.gov record NCT03151304. 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 Two-Stage, Open-Label Phase 2 Study of Pracinostat and Azacitidine in Patients With IPSS-R High and Very High Risk Myelodysplastic Syndromes Previously Untreated With Hypomethylating Agents
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 2, two-stage study of the safety and efficacy of pracinostat in combination with azacitidine in patients with IPSS-R high and very high risk myelodysplastic syndrome (MDS) who are previously untreated with hypomethylating agents (HMAs). Enrollment in this study will be limited to high/very high risk MDS because this group represents the highest unmet need, with median survival of less than 18 months. Stage 1a will be conducted as an open-label single arm in up to 40 subjects to assess if this regimen with a lower pracinostat dose results in a discontinuation rate that meets a predefined threshold and in efficacy that justifies expansion of enrollment into Stage 1b. A discontinuation rate of approximately ≤10% in Stage 1a, a rate comparable to that observed with azacitidine alone in study MEI-003 (NCT01873703), supports expansion into Stage 1b. Stage 1b will be conducted as expansion of stage 1a. Approximately 20 additional subjects will be enrolled. Study drugs should be continued until disease progression or intolerable toxicity. It is important to note that the median time to achieving a response with azacitidine alone is 4 to 5 months. Furthermore, the median time to achieving a Complete Response (CR) in study MEI-003 (NCT01873703) was 4 cycles. Therefore, early (\<6 months) discontinuation of trial therapy for 'no response' should be avoided. The Medical Monitor should be contacted prior to discontinuing a subject from the study to discuss the rationale for discontinuation.
Study identification
- NCT ID
- NCT03151304
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 64 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
- Jun 1, 2017 (Actual)
- Primary completion
- Dec 1, 2020 (Actual)
- Completion
- Dec 1, 2020 (Actual)
- Last update posted
- Mar 2, 2022
2017 – 2020
United States locations
- U.S. sites
- 25
- U.S. states
- 17
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| Scripps Cancer Center-Mercy | San Diego | California | 92103 | — |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | 30912 | — |
| georgia cancer Center | Augusta | Georgia | 30912 | — |
| Pontchartrain cancer Center | Covington | Louisiana | 70433 | — |
| RCCA MD LLC (The Center for Cancer and Blood Disorders) | Bethesda | Maryland | 20817 | — |
| Michigan Center of Medical Research | Farmington Hills | Michigan | 48334 | — |
| Michigan State University, Breslin Cancer Center | Lansing | Michigan | 48910 | — |
| university of minnesota medical Center, Fairview | Minneapolis | Minnesota | 55455 | — |
| Mercy Medical Research Institute | Springfield | Missouri | 65807 | — |
| New Mexico Cancer care Alliance | Albuquerque | New Mexico | 87131 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Southeastern Medical Oncology Center | Goldsboro | North Carolina | 27534 | — |
| Oncology Hematology Care | Cincinnati | Ohio | 45242 | — |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | — |
| Cancer Centers of Southwest Oklahoma | Lawton | Oklahoma | 73501 | — |
| Oklahoma Cancer Specialists and Research Institute | Tulsa | Oklahoma | 74146 | — |
| Providence Portland Medical center | Portland | Oregon | 97213 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| UVA Health System Division of Hematology & Oncology | Charlottesville | Virginia | 22908 | — |
| Swedish Cancer Institute | Seattle | Washington | 98104 | — |
| Universityof Wisconsin Clinical Science Center | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03151304, 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 Mar 2, 2022 · Synced Oct 22, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03151304 live on ClinicalTrials.gov.