A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
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Official title
An Open-label Phase 1b Study of PF-04449913 (Glasdegib) in Combination With Azacitidine in Patients With Previously Untreated Higher-Risk Myelodysplastic Syndrome, Acute Myeloid Leukemia, or Chronic Myelomonocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This multi center open label Phase 1b study is designed to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of glasdegib (PF-04449913) when combined with azacitidine in patients with previously untreated Higher Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML), or Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a safety lead in cohort (LIC) and (b) an expansion phase with an AML cohort and an MDS cohort.
Study identification
- NCT ID
- NCT02367456
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 73 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
- Apr 28, 2015 (Actual)
- Primary completion
- Jan 29, 2020 (Actual)
- Completion
- Mar 7, 2022 (Actual)
- Last update posted
- Jan 19, 2024
2015 – 2022
United States locations
- U.S. sites
- 21
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham the Kirklin Clinic | Birmingham | Alabama | 35233 | — |
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | — |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093 | — |
| Smilow Cancer Center at Yale New Haven Hospital | New Haven | Connecticut | 06510 | — |
| The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore | Maryland | 21287 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | — |
| Stony Brook University Hospital Cancer Center | Stony Brook | New York | 11794 | — |
| Stony Brook University | Stony Brook | New York | 11794 | — |
| Montefiore Einstein Center for Cancer | The Bronx | New York | 10461 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Duke University Health System: Adult Bone Marrow Transplant Clinic | Durham | North Carolina | 27705 | — |
| Duke University Health System, Duke University Hospital | Durham | North Carolina | 27710 | — |
| Duke University Health System | Durham | North Carolina | 27710 | — |
| Investigational Chemotherapy Service | Durham | North Carolina | 27710 | — |
| Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | 44195 | — |
| Henry-Joyce Cancer Center | Nashville | Tennessee | 37232 | — |
| Vanderbilt - Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Huntsman Cancer Hospital | Salt Lake City | Utah | 84112 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
| Seattle Cancer Care Alliance (SCCA) | Seattle | Washington | 98109 | — |
| University of Washington Medical Center (UWMC) | Seattle | Washington | 98195 | — |
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 12 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02367456, 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 Jan 19, 2024 · Synced Nov 15, 2026
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