Delving into the Latest Updates on Glasdegib Maleate with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

DAURISMO, Glasdegib, 格拉吉布

+ [5]

Target

SMO

Mechanism

SMO antagonists(Smoothened receptor antagonists)

Therapeutic Areas

NeoplasmsHemic and Lymphatic DiseasesOther Diseases

Active Indication

Acute Myeloid LeukemiaAdult Acute Myeloblastic LeukemiaChronic Myelomonocytic Leukemia+ [1]

Inactive Indication

Chronic graft-versus-host diseaseFasciitisGlioblastoma+ [10]

Originator Organization

Pfizer Inc.

Active Organization

Pfizer Inc.Pfizer Europe MA EEIG

Inactive Organization

Huizhi Pharmaceutical (Dalian) Co., Ltd.

National Cancer Institute

University of Colorado Denver

Drug Highest PhaseApproved

First Approval Date

US (21 Nov 2018),

Adult Acute Myeloblastic Leukemia

RegulationOrphan Drug (US), Orphan Drug (EU)

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Structure

Molecular FormulaC25H26N6O5

InChIKeyVJCVKWFBWAVYOC-UIXXXISESA-N

CAS Registry2030410-25-2

This phase Ib trial evaluates the best dose and effect of glasdegib in combination with venetoclax and decitabine, or gilteritinib, bosutinib, ivosidenib, or enasidenib in treating patients with acute myeloid leukemia that has come back (relapsed) after stem cell transplantation. Chemotherapy drugs, such as venetoclax and decitabine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Glasdegib, bosutinib, ivosidenib, and enasidenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Glasdegib inhibits the Sonic the Hedgehog gene. Venetoclax inhibits BCL-2 gene. Bosutinib is a tyrosine kinase inhibitor that inhibits BCR-ABL gene fusion. Ivosidenib inhibits isocitrate dehydrogenase-1 gene or IDH-1. Enasidenib inhibits isocitrate dehydrogenase-2 gene or IDH-2. This study involves an individualized approach that may allow doctors and researchers to more accurately predict which treatment plan works best for patients with relapsed acute myeloid leukemia.

Start Date25 Jun 2022

Sponsor / Collaborator

City of Hope National Medical Center

[+1]

NCT04842604 / CompletedPhase 3

A MULTI-CENTER CONTINUATION STUDY EVALUATING AZACITIDINE WITH OR WITHOUT GLASDEGIB (PF-04449913) IN PATIENTS WITH PREVIOUSLY UNTREATED ACUTE MYELOID LEUKEMIA, MYELODYSPLASTIC SYNDROME OR CHRONIC MYELOMONOCYTIC LEUKEMIA

An open-label study available to all eligible participants from Study B1371019 and participants originating from Study B1371012 continuing on study intervention with azacitidine with or without glasdegib.

Start Date17 May 2021

Sponsor / Collaborator

Pfizer Inc.

NCT04093505 / TerminatedPhase 3IIT

Randomized Phase-III Study to Compare Two Schedules of Gemtuzumab Ozogamicin as Adjunct to Intensive Induction Therapy and to Compare Intensive Postremission Therapy Double Blinded With or Without Glasdegib in Older Patients With Newly Diagnosed AML

The study is a randomized phase III trial with a 2x2 factorial design with measurable residual disease and event-free survival as primary endpoints, respectively. Patients are upfront randomized for the two induction schedules (Gemtuzumab Ozogamicin (GO)-147 versus GO-1; ratio 1:1) and for Glasdegib or Placebo (double blinded, ratio 1:1) as adjunct to consolidation therapy and as single agent 6 months maintenance therapy. Chemotherapy backbone for induction therapy is standard 7+3 with cytarabine 200mg/m² continuously day 1 to day 7, daunorubicin 60mg/m² days 1, 2 and 3 and for consolidation therapy intermediate dose cytarabine (1g/m², bi-daily, days 1,2,3). The trial is designed to gain evidence of anti-leukemic activity of GO and Glasdegib in older patients with newly diagnosed acute myeloid leukemia.

Start Date01 Apr 2021

Sponsor / Collaborator-

100 Clinical Results associated with Glasdegib Maleate

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100 Translational Medicine associated with Glasdegib Maleate

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100 Patents (Medical) associated with Glasdegib Maleate

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127

Literatures (Medical) associated with Glasdegib Maleate

01 May 2024·Anti-cancer agents in medicinal chemistry

An Expedition on Synthetic Methodology of FDA-approved Anticancer Drugs (2018-2021)

Review

Author: Gupta, Ghanshyam Das ; Jain, Ankit ; Vishakha, S ; Verma, Sant Kumar ; Navneesh, N ; Patel, Preeti ; Kurmi, Balak Das

Abstract::

New drugs being established in the market every year produce specified structures for selective biological targeting. With medicinal insights into molecular recognition, these begot molecules open new rooms for designing potential new drug molecules. In this review, we report the compilation and analysis of a total of 56 drugs including 33 organic small molecules (Mobocertinib, Infigratinib, Sotorasib, Trilaciclib, Umbralisib, Tepotinib, Relugolix, Pralsetinib, Decitabine, Ripretinib, Selpercatinib, Capmatinib, Pemigatinib, Tucatinib, Selumetinib, Tazemetostat, Avapritinib, Zanubrutinib, Entrectinib, Pexidartinib, Darolutamide, Selinexor, Alpelisib, Erdafitinib, Gilteritinib, Larotrectinib, Glasdegib, Lorlatinib, Talazoparib, Dacomitinib, Duvelisib, Ivosidenib, Apalutamide), 6 metal complexes (Edotreotide Gallium Ga-68, fluoroestradiol F-18, Cu 64 dotatate, Gallium 68 PSMA-11, Piflufolastat F-18, 177Lu (lutetium)), 16 macromolecules as monoclonal antibody conjugates (Brentuximabvedotin, Amivantamab-vmjw, Loncastuximabtesirine, Dostarlimab, Margetuximab, Naxitamab, Belantamabmafodotin, Tafasitamab, Inebilizumab, SacituzumabGovitecan, Isatuximab, Trastuzumab, Enfortumabvedotin, Polatuzumab, Cemiplimab, Mogamulizumab) and 1 peptide enzyme (Erwiniachrysanthemi-derived asparaginase) approved by the U.S. FDA between 2018 to 2021. These drugs act as anticancer agents against various cancer types, especially non-small cell lung, lymphoma, breast, prostate, multiple myeloma, neuroendocrine tumor, cervical, bladder, cholangiocarcinoma, myeloid leukemia, gastrointestinal, neuroblastoma, thyroid, epithelioid and cutaneous squamous cell carcinoma. The review comprises the key structural features, approval times, target selectivity, mechanisms of action, therapeutic indication, formulations, and possible synthetic approaches of these approved drugs. These crucial details will benefit the scientific community for futuristic new developments in this arena.

01 Apr 2024·Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research

A Review of Meaningful Change Thresholds for EORTC QLQ-C30 and FACT-G Within Oncology

Review

Author: Cocks, Kim ; Bennett, Bryan ; Dhanda, Devender ; Clarke, Nathan A ; Braverman, Julia ; Worthy, Gill ; Shaw, James W

OBJECTIVES:

This literature review provides an overview of meaningful change thresholds for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) and the Functional Assessment of Cancer Therapy - General (FACT-G) used across hematological cancers and solid tumors (melanoma, lung, bladder, and prostate).

METHODS:

Embase, MEDLINE, and PubMed were searched to identify relevant oncology publications from 2016 to 2021. Label claims from the US Food and Drug Administration and the European Medicines Agency for 7 recently approved drugs (pembrolizumab, atezolizumab, glasdegib, gilteritinib, tisagenlecleucel, axicabtagene ciloleucel, and daratumumab plus hyaluronidase-fihj) were reviewed.

RESULTS:

Publications providing guidance on meaningful change thresholds for the QLQ-C30 displayed a growing trend away from broad "legacy" thresholds of 10 points for all QLQ-C30 scales), toward deriving "contemporary" thresholds (eg, subscale specific, population specific). Contemporary publications generally provide guidance on selecting thresholds for specific scales that account for improved or worsening thresholds (eg, QLQ-C30 subscales). This trend was not clear for FACT-G, with less new guidance available. Most clinical trials used in regulatory label submissions have used thresholds of 10 points for the QLQ-C30 subscales and 3 to 7 points for the FACT-G total score. Despite the availability of more recent guidelines, contemporary meaningful change thresholds seem slow to emerge in the published literature and regulatory labels.

CONCLUSIONS:

Trialists should consider using contemporary thresholds, rather than legacy thresholds, for QLQ-C30 endpoints. Thresholds derived for a similar patient-population should be used where available. Further work is required to provide these across a broader range of cancer sites.

01 Jan 2024·Journal of clinical pharmacology

Physiologically Based Pharmacokinetic Modeling of the Drug–Drug Interaction Between CYP3A4 Substrate Glasdegib and Moderate CYP3A4 Inducers in Lieu of a Clinical Study

Article

Author: Doran, Angela C ; Goosen, Theunis C ; Shaik, Naveed ; Tse, Susanna ; Callegari, Ernesto

Abstract:

Glasdegib (DAURISMO) is a hedgehog pathway inhibitor approved for the treatment of acute myeloid leukemia (AML). Cytochrome P450 3A4 (CYP3A4) has been identified as a major metabolism and clearance pathway for glasdegib. The role of CYP3A4 in the clearance of glasdegib has been confirmed with clinical drug–drug interaction (DDI) studies following the coadministration of glasdegib with the strong CYP3A4 inhibitor ketoconazole and the strong inducer rifampin. To evaluate potential drug interactions with CYP3A4 modulators, the coadministration of glasdegib with a moderate CYP3A4 inducer, efavirenz, was evaluated using physiologically based pharmacokinetic (PBPK) modeling using the Simcyp simulator. The glasdegib compound file was developed using measured physicochemical properties, data from human intravenous and oral pharmacokinetics, absorption, distribution, metabolism, and excretion studies, and in vitro reaction phenotyping results. The modeling assumptions, model parameters, and assignments of fractional CYP3A4 metabolism were verified using results from clinical pharmacokinetics (PK) and DDI studies with ketoconazole and rifampin. The verified glasdegib and efavirenz compound files, the latter of which was available in the Simcyp simulator, were used to estimate the potential impact of efavirenz on the PK of glasdegib. PBPK modeling predicted a glasdegib area under the concentration–time curve ratio of 0.45 and maximum plasma concentration ratio of 0.75 following coadministration with efavirenz. The PBPK results, in lieu of a formal clinical study, informed the drug label, with the recommendation to double the clinical dose of glasdegib when administered in conjunction with a moderate CYP3A4 inducer, followed by a resumption of the original dose 7 days post‐discontinuation.

2

News (Medical) associated with Glasdegib Maleate

12 Apr 2021

·www.globenewswire.com

Global Acute Myeloid Leukemia (AML) Disease Analysis Report 2021: On Average, it Takes 10.8 Years from Phase I to Approval, Compared to 9.6 Years in the Overall Oncology Space

Dublin, April 12, 2021 (GLOBE NEWSWIRE) -- The "Disease Analysis: Acute Myeloid Leukemia (AML)" report has been added to ResearchAndMarkets.com's offering. AML is a type of heterogeneous hematological malignancy that originates from immature white blood cells (blasts) in the bone marrow, which may be derived from either a hematopoietic stem cell or a lineage-specific progenitor cell. "Acute" means that the leukemia may progress rapidly - AML generally spreads quickly to the bloodstream and can then spread to other parts of the body including the lymph nodes, spleen, central nervous system, and testicles.Latest Key TakeawaysThe publisher estimates that in 2018, there were 158,400 incident cases of acute myeloid leukemia (AML) worldwide and expects that number to increase to 169,000 incident cases by 2027. Approximately 60% of newly diagnosed patients are eligible for intensive chemotherapy, such as the 7+3 regimen of cytarabine and daunorubicin.Since 2017, there have been nine new drugs approved for AML in the US, dramatically changing the treatment landscape. Gone is the era where all front-line patients received either 7+3 chemotherapy or a hypomethylating agent (decitabine or azacitidine). Many of the new therapies target specific segments of AML or patients with specific mutations. As such, there is currently little competition between the new therapies, but that will change as therapies receive label expansions and new competitor therapies are approved.Two FLT3 inhibitors have been approved for FLT3-mutated AML: Rydapt for front-line patients eligible for intensive chemotherapy, and Xospata for relapsed/refractory patients. Rydapt may soon face competition in the front-line FLT3 setting as quizartinib, crenolanib, and Xospata are being evaluated in combination with standard chemotherapy and as single-agent maintenance therapies following either chemotherapy consolidation or hematopoietic stem cell transplant (HSCT). Approval in the lucrative maintenance setting would give these drugs a favorable long-term commercial outlook. Approximately 25-30% of AML patients have an FLT3 mutation.Tibsovo and Idhifa are approved in the US as oral, single-agent therapies for relapsed/refractory AML patients with IDH1 and IDH2 mutations, respectively. Tibsovo is also approved as a monotherapy for front-line patients over the age of 75 years. Both of these IDH inhibitors are now in Phase III trials in combination with standard induction (7+3) and consolidation chemotherapy and as maintenance therapy in front-line AML. Tibsovo is also being investigated in combination with azacitidine in a Phase III trial in front-line patients. Approval of Tibsovo and Idhifa in the EU will depend on these Phase III results. Tibsovo may face competition from FT-2102, an IDH1 inhibitor being evaluated in the relapsed/refractory setting in a pivotal single-arm Phase II trial. IDH1 mutations are present in 6-9% of AML, while IDH2 mutations are present in approximately 12% of cases.Mylotarg, an antibody-drug conjugate targeting CD33, is the only monoclonal antibody therapy approved for AML. Mylotarg combined with intensive chemotherapy is recommended for newly diagnosed patients with favorable cytogenetic risk (approximately 10% of patients eligible for intensive chemotherapy). Over 90% of AML patients are positive for CD33 expression.Vyxeos, a liposomal formulation of the 7+3 chemotherapy regimen, was approved in the US and EU for the treatment of newly diagnosed patients with secondary AML after showing an improvement in overall survival compared to the 7+3 regimen in patients ?60 years of age. Secondary AML accounts for approximately one third of new AML diagnoses, but most of these patients will be too frail for Vyxeos. Approximately 16% of patients eligible for intensive chemotherapy have secondary AML. Market access for Vyxeos is strengthened by positive recommendations from the US Centers for Medicare and Medicaid Services and from NICE in England and Wales.Venclexta combined with azacitidine is the new standard of care for newly diagnosed AML patients not suited for intensive chemotherapy (approximately 40% of newly diagnosed patients). A confirmatory Phase III trial evaluating Venclexta + azacitidine demonstrated a survival advantage (15 months versus 10 months) and supported regulatory submissions to European and Japanese authorities, with approvals expected in 2021. Venclexta is currently being evaluated in combination with novel agents in several trials, and a Phase III study (VIALE-M) is evaluating Venclexta combined with azacitidine as maintenance therapy for AML patients in first remission after conventional chemotherapy.Daurismo is the first and only Hedgehog pathway inhibitor approved for AML. Daurismo is approved in combination with low-dose cytarabine (LDAC) for newly diagnosed AML patients not suited for intensive chemotherapy, and will compete with Venclexta in this difficult-to-treat setting. However, in the US, hypomethylating agents are preferred over LDAC, so Venclexta may be preferred over Daurismo.Onureg, an oral formulation of azacitidine, increased overall survival and relapse-free survival in a Phase III trial and was approved in the US as a maintenance therapy following intensive chemotherapy for patients not suited for an HSCT. A European approval decision is expected in mid-2021. The maintenance setting would be a new setting for Vidaza (azacitidine) which is currently used in the EU (and off-label in the US) to treat newly diagnosed elderly AML patients.Rafael Pharmaceuticals is developing devimistat (CPI-613) as a first-in-class therapeutic targeting the altered mitochondrial metabolism present in many cancers, including AML. Devimistat's outlook will depend on the efficacy and safety results from a Phase III trial evaluating the drug in combination with high-dose cytarabine and mitoxantrone in relapsed/refractory AML patients. The first interim analysis is expected in Q2 2021.Chimerix's dociparstat sodium (DSTAT), a glycosaminoglycan analog of heparin designed to have reduced anticoagulant effects, targets the CXCR4 pathway which is involved in the homing and adhesion of AML cells to the bone marrow and is associated with resistance to systemic drugs. DSTAT is being developed in combination with intensive 7+3 chemotherapy for newly diagnosed AML, with the aim of improving the rate of durable response. A Phase III trial is enrolling patients with intermediate or unfavorable cytogenetic risk (74% of patients eligible for intensive chemotherapy).Otsuka's Inqovi is an oral formulation of decitabine that is being developed for patients with AML unsuited for intensive induction chemotherapy. In ASCERTAIN, a Phase III trial enrolling patients with MDS, Inqovi met the trial's primary endpoint of demonstrating pharmacokinetic equivalence to intravenous decitabine. ASCERTAIN has now been extended to include patients with AML in the EU, but a trial with efficacy endpoints will be needed to secure a US AML approval.Takeda's pevonedistat targets the NEDD8-activating enzyme in the ubiquitin-proteasome pathway, and is being developed in combination with azacitidine for a subpopulation of newly diagnosed, elderly AML patients categorized as low-blast count AML. Pevonedistat is also being evaluated in a randomized Phase II trial in combination with Venclexta and azacitidine in newly diagnosed AML patients unfit for intensive chemotherapy.Zeltherva is a therapeutic vaccine being developed as maintenance therapy for patients who have achieved hematologic complete remission, with or without thrombocytopenia, after second-line therapy and who are ineligible for allogeneic stem cell transplantation. Zeltherva's outlook in the specialized setting of CR2 will depend on results in REGAL, its Phase III trial. An interim analysis for safety and futility is expected in Q4 2021.Not including FLT3 and IDH inhibitors, there are five drugs in late-phase development for newly diagnosed AML patients. Dociparstat sodium and entospletinib are being developed in combination with intensive chemotherapy, while MBG453, pevonedistat, and Inqovi are being developed for elderly patients.Relapsed/refractory AML remains an area of unmet need, and new therapies are being developed. Not including FLT3 or IDH inhibitors, there are currently five late-stage therapies being evaluated for this setting (devimistat, DFP-10917, flotetuzumab, Iomab-B, and uproleselan).Key recent events include the approval of Onureg and presentation of numerical data from Venclexta's VIALE-A trial. There were Phase III failures for Helsinn's pracinostat combined with azacitidine in the newly diagnosed setting and for Roche's idasanutlin and Otsuka's guadecitabine in the relapsed/refractory setting. Other Phase III failures include trials evaluting Xospata combined with azacitidine and Daurismo combined with intensive chemotherapy in front-line AML, and an Idhifa monotherapy trial in the third- and fourth-line setting.Key upcoming catalysts for 2021 include topline results from Phase III trials for devimistat, Iomab-B, uproleselan, and Zeltherva, and a possible NDA submission for FT-2102.The overall likelihood of approval of a Phase I AML asset is 6.3%, and the average probability a drug advances from Phase III is 50%. AML drugs, on average, take 10.8 years from Phase I to approval, compared to 9.6 years in the overall oncology space. Companies Mentioned For more information about this report visit

AntibodyFirst in ClassVaccineADC

28 Jan 2021

·www.biospace.com

Biofidelity appoints Wendy J. Levin MD MS as Chief Medical Officer

Experienced US-based medical oncologist joins Biofidelity prior to launch of first diagnostic product US-trained oncologist & hematologist with over 15 years industry experience in translational medicine and drug development Global clinical lead for the Pfizer SMO Inhibitor, Daurismo, from pre-IND to FDA approval Clinical development and medical affairs leadership for multiple publicly-traded and private companies CAMBRIDGE, United Kingdom, Jan. 28, 2021 (GLOBE NEWSWIRE) -- Biofidelity Ltd, the cancer diagnostics company, today announces the appointment of Wendy J. Levin MD MS as Chief Medical Officer, based in the US. Following Biofidelity's recent Series A financing, supported by experienced investors BlueYard Capital, Longwall Ventures and Agilent Technologies, the Company is now focused on expanding its executive team as it works towards launch of the Identi-Lung panel in 2021. Dr. Levin's appointment follows those of former Roche executive Heiner Dreismann as Chairman, Stephen Miller as Chief Commercial Officer and Robert Osborne as Chief Operating Officer. Dr. Levin joins Biofidelity with over 15 years of experience in the biotechnology industry, spanning a broad range of disease indications, therapeutic targets and early- to late-phase development. Dr. Levin began her undergraduate and graduate career at the University of California Los Angeles (UCLA), where, under the guidance of Dr. Dennis J. Slamon, she co-authored the first publications on HER-2/neu in breast and ovarian cancers. She completed her Internal Medicine residency at University of Southern California, and her Fellowship at the University of Washington/Fred Hutchinson Cancer Research Center. As an Attending Physician at the University of Washington, she focused on malignant hematology and sarcoma, while maintaining an active laboratory presence. Click on, or paste the following link into your web browser, to view the associated PDF document. This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit .

100 Deals associated with Glasdegib Maleate

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Glasdegib Maleate	L01XX63	DB11978

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Acute Myeloid Leukemia	EU	Pfizer Europe MA EEIG	26 Jun 2020
Acute Myeloid Leukemia	IS	Pfizer Europe MA EEIG	26 Jun 2020
Acute Myeloid Leukemia	LI	Pfizer Europe MA EEIG	26 Jun 2020
Acute Myeloid Leukemia	NO	Pfizer Europe MA EEIG	26 Jun 2020
Adult Acute Myeloblastic Leukemia	US	Pfizer Inc.	21 Nov 2018

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Myelomonocytic Leukemia	Phase 3	JP	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	AT	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	CA	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	CZ	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	FR	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	HU	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	IT	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	MX	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	PL	Pfizer Inc.	17 May 2021
Chronic Myelomonocytic Leukemia	Phase 3	ES	Pfizer Inc.	17 May 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01286467 (CTgov)	Phase 1	Solid tumor	23	PF-04449913 (PF-04449913 80 mg)	vucoxeintc(foedojelqb) = npczlnrcmy qxhkqvdfsh (cxopqrpzsn, pqfumuixaj - acwkirqgha) View more	-	06 Mar 2024
				PF-04449913 (PF-04449913 160 mg)	vucoxeintc(foedojelqb) = thgvpgqgpz qxhkqvdfsh (cxopqrpzsn, xijsqqrivo - ztcrmrjzeu) View more
NCT04842604 (CTgov)	Phase 3	Acute Myeloid Leukemia \| Chronic Myelomonocytic Leukemia \| Myelodysplastic Syndromes	14	Glasdegib+Azacitidine (Glasdegib + Azacitidine)	mabjlowevy(rcrvxwndnb) = xhhnkpjnhe xcmyltvchf (gzjyblfvlr, srlfyjjcph - kjmitubdzh) View more	-	18 Dec 2023
				Placebo+Azacitidine (Placebo + Azacitidine)	mabjlowevy(rcrvxwndnb) = mtppusjngc xcmyltvchf (gzjyblfvlr, sdqxwxrilr - xvnlcmwnsw) View more
EUCTR2017-002410-31-ES \| NCT03466450 (GEINO 1602, ESMO2023) Manual	Phase 1/2	Glioblastoma First line	79	Glasdegib+temozolomide+radiotherapy	jbohvfhjxg(fananuoiql) = ryvojyusxw yxffybmrqc (rksfsbggsr, 14-21.2) View more	Positive	20 Oct 2023
				Glasdegib+temozolomide+radiotherapy (MGMT methylated)	jbohvfhjxg(fananuoiql) = zrktkvdgfo yxffybmrqc (rksfsbggsr, 16-NR) View more
NCT03416179 (BRIGHT AML 1019, Pubmed)	Phase 3	untreated pediatric acute nonlymphocytic leukemia	730	Glasdegib plus intensive chemotherapy (cytarabine and daunorubicin)	ayqsdtkllw(ybsrbqxdgv) = The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study trbaxpkvhe (pexjbvrral ) View more	Negative	21 Aug 2023
				Glasdegib plus non-intensive chemotherapy (azacitidine)
NCT03390296 (CTgov)	Phase 1/2	Relapsing acute myeloid leukemia \| Refractory acute myeloid leukemia	50	Anti-OX40 Agonist Monoclonal Antibody PF-04518600 (Arm A (Anti-OX40 Antibody PF-04518600))	aafcnadnfy(tqibysdvmv) = whojhvivcs wrqkwlrdim (gkvxqihzdw, grzekmvxam - uhovuunquv) View more	-	24 May 2023
				Venetoclax+Gemtuzumab Ozogamicin+azacitidine (Arm B (Azacitidine, Venetoclax, GO))	aafcnadnfy(tqibysdvmv) = xszfakcrru wrqkwlrdim (gkvxqihzdw, dbuvahmdyz - jjtlyamlvj) View more
NCT03466450 (GEINO 1602, ASCO2022) Manual	Phase 1/2	Glioblastoma First line	74	temozolomide+radiotherapy+glasdegib	hccckxsaao(wfojcxcqqk) = glasdegib at 75 mg/QD dose oyhnnuxphj (yrhxcfblpq ) View more	Positive	02 Jun 2022
				temozolomide+radiotherapy+glasdegib
NCT02367456 (Pubmed) Manual	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	72	Glasdegib Maleate+Azacitidine (AML)	vjvxhbanft(omwhtofbai) = In the expansion cohort, the most frequently (≥ 10%) reported non-hematologic Grade ≥ 3 treatment-emergent adverse events were decreased appetite, electrocardiogram QT prolongation, and hypertension in the AML cohort and sepsis, diarrhea, hypotension, pneumonia, and hyperglycemia in the MDS cohort. qjaviondud (gamtbhgvir )	Positive	30 Apr 2022
				Glasdegib Maleate+Azacitidine (MDS)
NCT02038777 (CTgov)	Phase 1	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	48	PF-04449913 (Monotherapy Cohort: PF-04449913 25 mg)	oolhnrcfif(wrwggpsegn) = fuoyhiifrl rhexamxgah (crsnbyvcbn, gqtjljbkrd - ezchvtlbmj) View more	-	18 Mar 2022
				PF-04449913 (Monotherapy Cohort: PF-04449913 50 mg)	oolhnrcfif(wrwggpsegn) = fghioiiisl rhexamxgah (crsnbyvcbn, lzskhswxva - konclswjls) View more
NCT04051996 (CTgov)	Phase 2	Acute Myeloid Leukemia	1	Decitabine+Glasdegib (DAC5)	croovcwfqr(meifpghitp) = pogylfvmvd koouekgihw (lnifaflwvs, rtnhpwtvrn - whzznfuhgf) View more	-	15 Oct 2021
				Decitabine+Glasdegib (DAC10)	croovcwfqr(meifpghitp) = mcihpdkjdc koouekgihw (lnifaflwvs, pdtplrckef - ltmtnkayji) View more
NCT03627754 (Pubmed) Manual	Phase 1	Liver Injury	24	Glasdegib	smptoctxhw(pppblipgzv): geometric mean ratios = 110.8 (90% CI, 78.0 - 157.3) View more	Positive	01 Jul 2021
				age/weight-matched controls