CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 73 enrolled
Drug / intervention
PF-04449913 (Glasdegib) +1 moredrug
Likely dose
PF-04449913 (Glasdegib) 100mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02367456
NCT02367456Phase 1Completed
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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

Pfizer·interventional·Posted Feb 20, 2015·Updated Jan 19, 2024

In Brief

A Phase 1 clinical trial evaluating PF-04449913 (Glasdegib) and Azacitidine for Myelodysplastic Syndrome and 2 related conditions. Completed, enrolled 73 participants across 33 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome, Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia
CountriesBelgium, Canada, France, Germany, United Kingdom, United States
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 20, 2015
Enrollment StartApr 28, 2015
Primary CompletionJan 29, 2020
Study CompletionMar 7, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 11.4 years ago

Interventions

PF-04449913 (Glasdegib)drug

Daily dose of PF-04449913 100mg tablet in a continuous regimen of 28 day cycles

Azacitidinedrug

75mg/m2 on Days 1-7 (+/- 3 days for each dose) of a 28 day cycle