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Generated: June 26, 2019

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CLINICAL TRIALS PROFILE FOR GLASDEGIB

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Clinical Trials for Glasdegib

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

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Clinical Trial Conditions for Glasdegib

Condition Name

Condition Name for Glasdegib
Intervention Trials
Healthy Volunteers 3
Healthy Volunteer Study 1
Renal Impairment 1
Glioblastoma 1
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Condition MeSH

Condition MeSH for Glasdegib
Intervention Trials
Renal Insufficiency 1
Polycythemia Vera 1
Syndrome 1
Glioblastoma 1
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Clinical Trial Locations for Glasdegib

Trials by Country

Trials by Country for Glasdegib
Location Trials
United States 29
Japan 13
Spain 4
Korea, Republic of 3
Belgium 3
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Trials by US State

Trials by US State for Glasdegib
Location Trials
Connecticut 4
California 3
New York 3
Texas 2
Ohio 2
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Clinical Trial Progress for Glasdegib

Clinical Trial Phase

Clinical Trial Phase for Glasdegib
Clinical Trial Phase Trials
Phase 3 2
Phase 2 1
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Glasdegib
Clinical Trial Phase Trials
Recruiting 6
Not yet recruiting 4
Completed 2
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Clinical Trial Sponsors for Glasdegib

Sponsor Name

Sponsor Name for Glasdegib
Sponsor Trials
Pfizer 9
Grupo Espanol de trasplantes hematopoyeticos y terapia celular 1
Plateforme labellisée Inca – Institut Bergonié, Bordeaux 1
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Sponsor Type

Sponsor Type for Glasdegib
Sponsor Trials
Industry 9
Other 8
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