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A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia

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Trial Profile

A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 232 Alone and in Combination With Trametinib in Adult Subjects With Relapsed/Refractory Acute Myeloid Leukemia

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 21 Jul 2020

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At a glance

  • Drugs Navtemadlin (Primary) ; Trametinib
  • Indications Acute myeloid leukaemia
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Amgen

    • Most Recent Events

    • 21 Jun 2020 Results assessing the effect of KRT-232 exposure on MIC-1 fold change from baseline and evaluate baseline serum MIC-1 level as a covariate in a PD exposure-response (E-R) model using data from two trials (NCT02016729 and NCT01723020), were presented at the 25th Congress of the European Haematology Association.
    • 23 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 29 Jun 2017 Planned End Date changed from 1 Apr 2018 to 31 Jul 2017.

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