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Last Updated: May 21, 2022

CLINICAL TRIALS PROFILE FOR GLASDEGIB


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All Clinical Trials for Glasdegib

Trial ID Title Status Sponsor Phase Start Date Summary
NCT02038777 ↗ A Study Of PF-04449913 In Japanese Patients With Select Hematologic Malignancies Active, not recruiting Pfizer Phase 1 2014-03-25 This is an open-label, multi-center, Phase 1 study of PF-04449913 in Japanese patients. PF-04449913 will be administered orally as a single agent in patients with select advanced hematologic malignancies, or in combination with LDAC [Low-Dose Ara-C] or cytarabine and daunorubicin in previously untreated patients with AML [Acute Myeloid Leukemia] or high-risk MDS [Myelodysplastic Syndrome], or in combination with azacitidine in previously untreated patients with AML.
NCT02226172 ↗ Single-Agent Glasdegib In Patients With Myelofibrosis Previously Treated With Ruxolitinib Terminated Pfizer Phase 2 2014-10-06 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 Untreated MDS, AML and CMML Patients Active, not recruiting Pfizer Phase 1 2015-04-28 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.
NCT02430545 ↗ Understanding The Effect Of A Strong CYP3A4 Inducer On Glasdegib Pharmacokinetics Completed Pfizer Phase 1 2015-05-01 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 Completed Pfizer Phase 1 2017-05-01 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 Completed Pfizer Phase 1 2017-06-09 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.
NCT03226418 ↗ Integrating Geriatric Assessment and Genetic Profiling to Personalize Therapy Selection in Older Adults With Acute Myeloid Leukemia Recruiting National Cancer Institute (NCI) Phase 2 2017-07-07 This phase II trial of the impact of clinicogenetic risk-stratified management on outcomes of acute myeloid leukemia in older patients is to determine the rate of complete remission and mortality at 90 days in the entire cohort of older patients (≥60 years) with newly diagnosed acute myeloid leukemia, who receive clinicogenetic risk-stratified therapy allocation. Subjects will receive standard of care intensive or low-intensity induction based on cytogenetic and geriatric assessment-based risk stratification. Subjects will be evaluated for disease status, survival, quality of life and neurocognitive status for 90 days and then followed for a total of 2 years for survival data.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Glasdegib

Condition Name

Condition Name for Glasdegib
Intervention Trials
Acute Myeloid Leukemia 6
Healthy Volunteers 3
Myelodysplastic Syndrome 2
Chronic Myelomonocytic Leukemia 2
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Condition MeSH

Condition MeSH for Glasdegib
Intervention Trials
Leukemia, Myeloid 11
Leukemia, Myeloid, Acute 11
Leukemia 10
Preleukemia 4
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Clinical Trial Locations for Glasdegib

Trials by Country

Trials by Country for Glasdegib
Location Trials
United States 44
Japan 22
China 10
Italy 9
Germany 7
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Trials by US State

Trials by US State for Glasdegib
Location Trials
Connecticut 5
California 5
Utah 3
Texas 3
Ohio 3
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Clinical Trial Progress for Glasdegib

Clinical Trial Phase

Clinical Trial Phase for Glasdegib
Clinical Trial Phase Trials
Phase 3 5
Phase 2 4
Phase 1/Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Glasdegib
Clinical Trial Phase Trials
Recruiting 8
Completed 6
Active, not recruiting 5
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Clinical Trial Sponsors for Glasdegib

Sponsor Name

Sponsor Name for Glasdegib
Sponsor Trials
Pfizer 14
National Cancer Institute (NCI) 4
University Hospital Heidelberg 1
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Sponsor Type

Sponsor Type for Glasdegib
Sponsor Trials
Other 20
Industry 15
NIH 4
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