Trials / Completed
CompletedNCT02367456
A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In Untreated MDS, AML and CMML Patients
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 73 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PF-04449913 (Glasdegib) | Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles |
| DRUG | Azacitidine | 75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle |
Timeline
- Start date
- 2015-04-28
- Primary completion
- 2020-01-29
- Completion
- 2022-03-07
- First posted
- 2015-02-20
- Last updated
- 2024-01-19
- Results posted
- 2021-03-05
Locations
33 sites across 6 countries: United States, Belgium, Canada, France, Germany, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02367456. Inclusion in this directory is not an endorsement.