A Non-randomised, Open-label, Sequential, Three-part, Phase I Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib Following Oral Dosing of a Tablet Formulation, and to Provide Data on the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours

Trial Profile

A Non-randomised, Open-label, Sequential, Three-part, Phase I Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib Following Oral Dosing of a Tablet Formulation, and to Provide Data on the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours

Completed
Phase of Trial: Phase I

Latest Information Update: 20 Oct 2016

At a glance

  • Drugs Olaparib (Primary) ; Itraconazole
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors AstraZeneca
  • Most Recent Events

    • 14 Oct 2016 Status changed from active, no longer recruiting to completed.
    • 10 Oct 2016 Results assessing effect of itraconazole on pharmacokinetics of olaparib (n=59) published in the Clinical Therapeutics.
    • 02 Jun 2015 Results assessing pharmacokinetics of olaparib in presence of itraconazole presented at the 51st Annual Meeting of the American Society of Clinical Oncology.
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