Clinical Trials

Numerous clinical trials across Phase I through Phase III evaluate glasdegib combination regimens in hematologic malignancies, solid tumors, and special populations, focusing primarily on untreated acute myeloid leukemia and newly diagnosed glioblastoma. Sponsored by pharmaceutical companies, academic medical centers, and cooperative research groups, these studies span diverse recruitment statuses, including recruiting, active, completed, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04231851 ACTIVE_NOT_RECRUITING
Acute Myelogenous Leukemia (AML) Due to Therapy; Acute Myeloid Leukemia With Myelodysplasia-Related Changes
University of California, Irvine
 2020-02-19 PHASE2
NCT03226418 COMPLETED
Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Therapy-Related Acute Myeloid Leukemia
University of Nebraska
 2017-07-07 PHASE2
NCT04655391 WITHDRAWN
Recurrent Acute Myeloid Leukemia
City of Hope Medical Center
 2022-06-25 PHASE1
NCT03784014 COMPLETED
Soft Tissue Sarcoma
Institut National de la Santé Et de la Recherche Médicale, France
 2019-10-19 PHASE3
NCT03466450 COMPLETED
Glioblastoma
Grupo Español de Investigación en Neurooncología
 2018-03-15 PHASE1; PHASE2
NCT04111497 TERMINATED
Chronic Graft Versus Host Disease; Fasciitis
Fred Hutchinson Cancer Center
 2019-12-03 PHASE1; PHASE2
NCT04842604 COMPLETED
Acute Myeloid Leukemia; Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
Pfizer
 2021-05-17 PHASE3
NCT04093505 TERMINATED
Acute Myeloid Leukemia
University Hospital Heidelberg
 2021-04-01 PHASE3
NCT03390296 COMPLETED
Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia
M.D. Anderson Cancer Center
 2017-12-27 PHASE1; PHASE2
NCT03415867 UNKNOWN
Sclerodermoid Chronic Graft-Versus-Host Disease (Disorder)
Grupo Espanol de trasplantes hematopoyeticos y terapia celular
 2018-01-09 PHASE1; PHASE2
NCT02038777 COMPLETED
Acute Myeloid Leukemia
Pfizer
 2014-03-25 PHASE1
NCT04168502 Recruiting
Acute Myeloid Leukemia
Gruppo Italiano Malattie EMatologiche dell''Adulto
 2020-09-24 Phase 3
NCT04051996 TERMINATED
ACUTE MYELOID LEUKEMIA
Yale University
 2019-12-06 PHASE2
NCT03416179 COMPLETED
Leukemia, Myeloid, Acute
Pfizer
 2018-04-20 PHASE3
NCT04231851 Recruiting
Acute Myelogenous Leukemia (AML) Due to Therapy|Acute Myeloid Leukemia With Myelodysplasia-Related Changes
University of California Irvine|Jazz Pharmaceuticals|Pfizer
 2020-02-19 Phase 2
NCT02367456 COMPLETED
Myelodysplastic Syndrome; Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia
Pfizer
 2015-04-28 PHASE1
NCT01841333 COMPLETED
Adult Acute Myeloid Leukemia in Remission; Recurrent Adult Acute Myeloid Leukemia
University of Colorado, Denver
 2013-04-29 PHASE2
NCT03627754 COMPLETED
Hepatic Impairment
Pfizer
 2018-11-05 PHASE1
NCT03627754 Completed
Hepatic Impairment
Pfizer
 2018-11-05 Phase 1
NCT03596567 COMPLETED
Renal Impairment
Pfizer
 2018-05-17 PHASE1
NCT03466450 Completed
Glioblastoma
Grupo Español de Investigación en Neurooncología
 2018-03-15 Phase 1|Phase 2
NCT03270878 COMPLETED
Healthy Volunteer Study
Pfizer
 2017-09-07 PHASE1
NCT03162900 COMPLETED
Healthy Volunteers
Pfizer
 2017-06-09 PHASE1
NCT03130556 COMPLETED
Healthy Volunteers
Pfizer
 2017-05-01 PHASE1
NCT01546038 COMPLETED
Acute Myeloid Leukemia
Pfizer
 2012-06-27 PHASE2
NCT02226172 TERMINATED
Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
Pfizer
 2014-10-06 PHASE2
NCT01842646 COMPLETED
Myelodysplastic Syndrome (MDS); Chronic Myelomonocytic Leukemia (CMML)
H. Lee Moffitt Cancer Center and Research Institute
 2013-08-29 PHASE2
NCT02430545 COMPLETED
Healthy Volunteers
Pfizer
 2015-05 PHASE1
NCT02367456 Completed
Myelodysplastic Syndrome|Acute Myeloid Leukemia|Chronic Myelomonocytic Leukemia
Pfizer
 2015-04-28 Phase 1
NCT02110342 COMPLETED
Healthy
Pfizer
 2014-05 PHASE1
NCT01749085 COMPLETED
Healthy Volunteers
Pfizer
 2012-12 PHASE1
NCT00953758 COMPLETED
Hematologic Malignancies
Pfizer
 2010-03-03 PHASE1
NCT01286467 COMPLETED
Solid Tumors
Pfizer
 2011-05-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-16)

Check the Glasdegib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Glasdegib acts as a potent, orally bioavailable inhibitor that selectively binds to the Smoothened (Smo) receptor to block downstream Hedgehog signal transduction. By disrupting Smoothened-mediated signaling cascades, the drug suppresses cancer stem cell survival and cell proliferation, thereby offering therapeutic efficacy against hematologic malignancies such as acute myeloid leukemia and myelodysplastic syndrome.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.