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Ambit and Astellas Announce Presentation of Results from Phase 2 ACE Study of Quizartinib in Patients with Relapsed or Refractory Acute Myeloid Leukemia (AML) at the 54th Annual Meeting of the American Society of Hematology
Date:12/10/2012

zartinib and may benefit from its future use. Quizartinib is well tolerated, with gastrointestinal toxicities being the most common as well as reversible QT prolongation which was infrequently grade 3 (with no cases of grade 4 in this patient cohort) at the doses used in this trial. These data suggest that quizartinib may be an attractive option in this heavily pretreated patient population with limited therapeutic options.  The benefit of bridge to HSCT had a clear impact in improving overall survival for these patients.

The Quizartinib Clinical Program
As of Dec. 1, 2012, approximately 450 patients have been enrolled into clinical trials evaluating quizartinib in AML, and in addition to the Phase 2 study presented this week, other ongoing trials with quizartinib include: 

  • "An Open Label Study to Evaluate the Safety and Efficacy of Two Doses of Quizartinib in Patients With Relapsed or Refractory Acute Myeloid Leukemia (NCT01565668)"  The purpose of this Phase 2b study is to assess the safety and efficacy of additional dose strengths of quizartinib monotherapy in relapsed or refractory AML patients.  In addition to evaluating clinical response and survival, assessment of PD biomarkers and pharmacokinetics (PK) will be performed.  Patient enrollment started in May 2012, and the study is currently ongoing.
  • "A Study to Assess AC220 Given in Combination With Induction and Consolidation Therapy in Newly Diagnosed Acute Myeloid Leukemia (AML) (NCT01390337)"  The purpose of this Phase 1 study is to define the maximum tolerated dose of quizartinib when combined with induction and consolidation therapy, and as a maintenance therapy following induction and consolidation.  Patient enrollment is ongoing.
  • "A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML) (NCT01468467)"  The purpose of this Phase 1 stud
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