Evaluation of the effects of formulation, food, or a proton-pump inhibitor on the pharmacokinetics of glasdegib (PF-04449913) in healthy volunteers: a randomized phase I study
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DOI: 10.1007/s00280-018-3748-8
Abstract: PurposeTo demonstrate the bioequivalence of the planned maleate salt-based commercial glasdegib tablet formulation [International Council for Harmonization (ICH) glasdegib] to the clinical di-hydrochloride (di-HCl) salt-based glasdegib formulation (di-HCl glasdegib). Additionally, to estimate the effects of… read more here.
Keywords: glasdegib; pump inhibitor; formulation; fasted conditions ... See more keywords
An evaluation of overall survival in patients with newly diagnosed acute myeloid leukemia and the relationship with glasdegib treatment and exposure
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DOI: 10.1007/s00280-020-04132-x
Abstract: Glasdegib, an oral inhibitor of the Hedgehog signaling pathway, is approved in the United States in combination with low-dose cytarabine (LDAC) to treat patients with newly diagnosed acute myeloid leukemia (AML) ineligible to receive intensive… read more here.
Keywords: patients newly; glasdegib; newly diagnosed; treatment ... See more keywords
Phase 1/2 trial of glasdegib in patients with primary or secondary myelofibrosis previously treated with ruxolitinib.
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DOI: 10.1016/j.leukres.2019.02.012
Abstract: Glasdegib is a potent and selective oral inhibitor of the Hedgehog pathway. We report data from the single-arm, lead-in cohort of an open-label phase 1b/2 trial of glasdegib in patients with primary/secondary myelofibrosis (MF) previously… read more here.
Keywords: glasdegib; trial glasdegib; primary secondary; patients primary ... See more keywords
A phase 2 trial of the oral smoothened inhibitor glasdegib in refractory myelodysplastic syndromes (MDS).
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DOI: 10.1016/j.leukres.2019.03.008
Abstract: Hypomethylating agent (HMA) failure myelodysplastic syndrome (MDS) patients have poor outcomes and urgent need for novel therapies. Hedgehog pathway signaling upregulation plays a central role in myeloid neoplasm pathogenesis and leukemia stem cell survival. We… read more here.
Keywords: hma failure; smoothened inhibitor; glasdegib; response ... See more keywords
Abstract 3889: Population pharmacokinetic/pharmacodynamic evaluation of the effect of glasdegib exposure on cardiac repolarization (QT interval) in cancer patients
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DOI: 10.1158/1538-7445.sabcs18-3889
Abstract: Glasdegib inhibits Hedgehog signaling through Smoothened. Glasdegib (100 mg once daily [QD]) is in clinical development as a first-line treatment for adults with acute myeloid leukemia (AML). In two dose-escalation studies, involving cancer patients with… read more here.
Keywords: glasdegib; population; interval; cancer ... See more keywords
Glasdegib for the treatment of adult patients with newly diagnosed acute myeloid leukemia or high-grade myelodysplastic syndrome who are elderly or otherwise unfit for standard induction chemotherapy.
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DOI: 10.1358/dot.2019.55.9.3020160
Abstract: On November 21, 2018, the U.S. Food and Drug Administration (FDA) approved glasdegib in combination with low-dose cytarabine (LDAC), for the treatment of newly diagnosed acute myeloid leukemia (AML) in patients > 75 years old… read more here.
Keywords: newly diagnosed; leukemia; glasdegib; induction chemotherapy ... See more keywords