TrialSignal
Clinical trial intelligence report
A RANDOMIZED (1:1), DOUBLE-BLIND, MULTI-CENTER, PLACEBO CONTROLLED STUDY EVALUATING INTENSIVE CHEMOTHERAPY WITH OR WITHOUT GLASDEGIB (PF-04449913) OR AZACITIDINE (AZA) WITH OR WITHOUT GLASDEGIB IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA
Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.
Generated
Jun 24, 2026
Report code
NCT03416179-Jun 24, 2026
NCT ID
NCT03416179
Status
COMPLETED
Phase
Phase 3
Sponsor
Pfizer
Executive brief
Investment-Ready Snapshot
Pfizer's glasdegib is being evaluated in a pivotal Phase 3 trial for the treatment of previously untreated acute myeloid leukemia (AML) in both intensive and non-intensive chemotherapy settings. The dual approach targeting both intensive and non-intensive populations positions glasdegib favorably in a competitive landscape where treatment options for AML are limited. The market for AML therapies is growing, driven by an increasing incidence of the disease and the need for novel therapies that improve survival rates. Successful outcomes from this trial could enhance Pfizer's portfolio in hematologic malignancies and provide a significant competitive edge against existing therapies, particularly in patients who are not candidates for intensive chemotherapy. Diligence should focus on the trial's overall survival (OS) and complete remission (CR) rates, as these will be critical for regulatory approval and market uptake.
Source & freshness
Provenance
https://clinicaltrials.gov/study/NCT03416179
Indication
Leukemia, Myeloid, Acute
Modality
small molecule
Target
Hedgehog signaling pathway inhibition via glasdegib (PF-04449913)
Intervention
glasdegib, daunorubicin + cytarabine, azacitidine, Placebo, Placebo, glasdegib, cytarabine, HSCT
Source record
Protocol Description
Detailed source ingestion pending.
Source record
Outcome Measures
Detailed source ingestion pending.
Source record
Eligibility
Detailed source ingestion pending.
AI analysis
Known Results And Readout Context
Detailed source ingestion pending.
IP intelligence
Patent And IP Landscape
Detailed source ingestion pending.
Source record
Contacts
Detailed source ingestion pending.