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

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

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 27 Jun 2018

At a glance

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

    • 27 Jun 2018 According to a Pfizer media release, based on the data of this study, the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application and granted Priority Review designation for Glasdegib for the treatment of adult patients with previously untreated acute myeloid leukemia (AML) in combination with low-dose cytarabine (LDAC), a type of chemotherapy. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in December 2018.
    • 17 Jun 2018 Results (n=132) presented at the 23rd Congress of the European Haematology Association
    • 20 Feb 2018 Results of phase Ib (n=52; 14 US centers) part published in the Clinical cancer research: an official journal of the American Association for Cancer Research.
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