CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 14 enrolled
Drug / intervention
Glasdegib +1 moredrug
Likely dose
Glasdegib 25 mgfrom 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/NCT04842604
NCT04842604Phase 3Completed

A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA

Pfizer·interventional·Posted Apr 13, 2021·Updated Dec 18, 2023

In Brief

A Phase 3 clinical trial evaluating Glasdegib and Azacitidine for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 14 participants across 18 sites in 11 countries.

Detailed Summary

An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, Czechia, France, Hungary, Italy, Japan, Mexico, Poland, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20222023202420252026
First PostedApr 13, 2021
Enrollment StartMay 17, 2021
Primary CompletionDec 2, 2022
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 5.2 years ago

Interventions

Glasdegibdrug

25 mg or 100 mg tablet

Azacitidinedrug

100 mg/vial powder for 25 mg/mL suspension for injection