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A Phase 1 Study to Evaluate the Effect of Itraconazole, a Strong CYP3A Inhibitor, on the Pharmacokinetics of Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

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Trial Profile

A Phase 1 Study to Evaluate the Effect of Itraconazole, a Strong CYP3A Inhibitor, on the Pharmacokinetics of Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs Alisertib (Primary) ; Itraconazole
  • Indications Lymphoma; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Takeda Oncology

    • Most Recent Events

    • 16 Aug 2019 Status changed from active, no longer recruiting to completed.
    • 30 Aug 2017 Results investigating the effect of gastric acid reducing agents and strong inducers/inhibitors of CYP3A4 on the pharmacokinetics of alisertib published in the Investigational New Drugs
    • 12 Mar 2016 Interim results (n = 20) presented at the 117th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics.

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