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CLINICAL TRIALS PROFILE FOR GLASDEGIB

Clinical Trials for Glasdegib

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Trial ID	Title	Status	Sponsor	Phase	Summary
NCT02226172	Single-Agent Glasdegib In Patients With Myelofibrosis Previously Treated With Ruxolitinib	Recruiting	Pfizer	Phase 2	A lead-in cohort of ~20 patients with primary or secondary myelofibrosis previously treated with 1 or more Janus kinase inhibitors enrolled to single-agent glasdegib to evaluate safety and tolerability. Following the lead-in, a phase 2, double blind, 2-arm study, randomized 2:1 to oral single-agent glasdegib versus placebo in 201 patients resistant or intolerant to ruxolitinib.
NCT02367456	A Combination Study of PF-04449913 (Glasdegib) and Azacitidine In 1st Line MDS, AML and CMML Patients	Recruiting	Pfizer	Phase 1	This multi center randomized (1:1), double blind, placebo controlled Phase 1b/2 study is designed to compare the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of PF 04449913 or placebo when combined with azacitidine in patients with previously untreated Intermediate 2 or High Risk Myelodysplastic Syndrome (MDS), Acute Myeloid Leukemia (AML) with 20-30% blasts and multi lineage dysplasia, and Chronic Myelomonocytic Leukemia (CMML). This clinical study includes two components: (a) a Phase 1b safety lead in and (b) a randomized Phase 2.
NCT02430545	Understanding The Effect Of A Strong CYP3A4 Inducer On Glasdegib Pharmacokinetics	Completed	Pfizer	Phase 1	The study also aims to determine the effect of a strong enzyme (CYP3A4) inducer-rifampin- on drug exposure of Glasdegib. This study will be conducted in healthy subjects given a single dose of glasdegib in each period.
NCT03130556	A Study Of Glasdegib In Healthy Volunteers To Establish The Bioequivalence Of The Phase 2 Formulation To The ICH Formulation	Recruiting	Pfizer	Phase 1	This study is intended to establish the bioequivalence (BE) of single 100 mg doses of glasdegib administered under fasted conditions to healthy volunteers as the ICH formulation compared to the Phase 2 formulation.
NCT03162900	A Phase 1 Study To Evaluate The Effect Of Glasdegib On The Cardiac Repolarization In Healthy Subjects	Not yet recruiting	Pfizer	Phase 1	This is a Thorough QT study intended to estimate the effect of glasdegib at therapeutic exposure and at supra-therapeutic exposure on cardiac repolarization in healthy subjects. This is a randomized, double blind, positive and placebo controlled study with a 6 day washout between successive periods.
NCT03270878	Glasdegib Absolute Bioavailability Study	Not yet recruiting	Pfizer	Phase 1	This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy volunteers.
Trial ID	Title	Status	Sponsor	Phase	Summary