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A Phase 1b/2 Study To Evaluate The Safety And Efficacy Of PF-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-C Or Decitabine In Patients With Acute Myeloid Leukemia Or High-Risk Myelodysplastic Syndrome

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Trial Profile

A Phase 1b/2 Study To Evaluate The Safety And Efficacy Of PF-04449913, An Oral Hedgehog Inhibitor, In Combination With Intensive Chemotherapy, Low Dose Ara-C Or Decitabine In Patients With Acute Myeloid Leukemia Or High-Risk Myelodysplastic Syndrome

Status: Completed
Phase of Trial: Phase I/II

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Glasdegib (Primary) ; Cytarabine; Cytarabine; Daunorubicin; Decitabine
  • Indications Acute myeloid leukaemia; Myelodysplastic syndromes
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms BRIGHT 1003; BRIGHT AML 1003; BRIGHT AML trial
  • Sponsors Pfizer

    • Most Recent Events

    • 01 May 2021 Results of long term follow up (>40 months) and post hoc subgroup analysis evaluating survival trend of Phase II study, published in the Annals of Hematology.
    • 08 Dec 2020 Results of pooled analysis of data from BRIGHT AML 1003 GLAS+LDAC trial and Phase III VEN+LDAC trial comparing the effectiveness of Glasdegib or Venetoclax in combination with Low-Dose Cytarabine presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology
    • 24 Sep 2020 Results (n=272) of pooled analysis of three clinical studies ((B1371001or NCT00953758), (B1371002 or NCT01286467) and (B1371003 or NCT01546038)) assessing evaluation of the relationship of Glasdegib exposure and safety end points in patients with refractory solid tumors and hematologic malignancies, published in the Journal of Clinical Pharmacology
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