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

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

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 30 Aug 2017

At a glance

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

    • 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.
    • 16 Nov 2015 Planned primary completion date changed from 1 Apr 2015 to 1 Apr 2016 as reported by ClinicalTrials.gov record.
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