Acute myeloid leukemia
Conditions
Interventions
investigational material(s)
Generic name etc : Glasdegib (PF-04449913)
INN of investigational material : Glasdegib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for
Drug: cytarabine
Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternativ
Sponsors
Pfizer R&D Japan G.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1.Subjects with untreated AML inclusing * AML arising from MDS or another antecedent hematologic disease (AHD). * AML after previous cytotoxic therapy or radiation (secondary AML). 2.Adequate Organ Function as defined by the following: 3.QTc interval 470 msec using the Fridericia correction (QTcF). 4.All anti cancer treatments (unless specified) should be discontinued 2 weeks from study entry, for example: targeted chemotherapy, radiotherapy, investigational agents, hormones, anagrelide or cytokines. *For control of rapidly progressing leukemia, all trans retinoic acid (ATRA), hydroxyurea, and/or leukopheresis may be used before and for up to 1 week after the first dose of glasdegib. etc.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1.Acute Promyelocytic Leukemia (APL) and APLwith PML RARA, subjects (WHO 2016 classification). 2.AML with BCR ABL1 or t(9;22)(q34;q11.2) as a sole abnormality. *Complex genetics may include t(9;22) cytogenetic translocation. 3.Subjects with known active CNS leukemia. 4.Participation in other clinical studies involving other investigational drug(s) within 4 weeks prior study entry and/or during study participation. 5.Subjects known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support. 6.Subjects with another active malignancy on treatment. 7.Any one of the following ongoing or in the previous 6 months: myocardial infarction, congenital long QT syndrome, Torsades de pointes, symptomatic arrhythmias (including sustained ventricular tachyarrhythmia), right or left bundle branch block and bifascicular block, unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF New York Heart Association class III or IV), cerebrovascular accident, transient ischemic attack or symptomatic pulmonary embolism; as well as bradycardia defined as <50 bpms. 8.Subjects with an active, life threatening or clinically significant uncontrolled systemic infection not related to AML. 9.Subjects with left ventricular ejection fraction (LVEF) <50% are excluded from the Intensive Chemotherapy Study only. 10.Current use or anticipated requirement for drugs that are known strong CYP3A4/5 inducers. 11.Major surgery or radiation within 4 weeks of starting study treatment. 12.Documented or suspected hypersensitivity to any one of the following: *For subjects assigned to intensive chemotherapy, documented or suspected hypersensitivity to cytarabine (not including drug fever or exanthema, including known cerebellar side effects) or daunorubicin. *For subjects assigned to non intensive chemotherapy, documented or suspected hypersensitivity to azacitidine or mannitol. etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy Overall Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety Efficacy Pharmacokinetics Pharmacogenomics * Rate of CR (including CRMRD-negative as assessed by multiparametric flow cytometry), CRi as defined by the ELN recommendations (2017), MLFS, PR, and CR with partial hematologic recovery (CRh) for the Non-intensive study only * Duration of response * Time to response in the non-intensive study only * Event-free Survival * Patient-Reported Outcomes * Adverse events, Laboratory abnormalities * Pharmacokinetics * QTc interval | — |
Countries
Asia except Japan, Europe, Japan, North America, Oceania, South America
Contacts
Public ContactClinical Trials Information Desk
Pfizer R&D Japan G.K.
Outcome results
None listed