A Phase 1 Study of Oral MLN9708 to Assess Drug-Drug Interaction With Ketoconazole, Relative Bioavailability, Food Effect, Drug-Drug Interaction With Rifampin, and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma

Trial Profile

A Phase 1 Study of Oral MLN9708 to Assess Drug-Drug Interaction With Ketoconazole, Relative Bioavailability, Food Effect, Drug-Drug Interaction With Rifampin, and Safety and Tolerability in Patients With Advanced Nonhematologic Malignancies or Lymphoma

Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2017

At a glance

  • Drugs Ixazomib (Primary) ; Clarithromycin; Ketoconazole; Rifampicin
  • Indications Lymphoma; Solid tumours; Waldenstrom's macroglobulinaemia
  • Focus Pharmacokinetics
  • Sponsors Takeda Oncology
  • Most Recent Events

    • 11 Aug 2017 Results published in the Journal of Clinical Pharmacology
    • 07 Aug 2017 Primary endpoint ( Ratio of geometric mean Cmax and AUC0-tlast of Capsule B formulation versus Capsule A formulation and 90% CI [ Time Frame: Cycle 1: Days 1-28 ] has been met, as per results published in the Journal of Clinical Pharmacology.
    • 07 Aug 2017 Results (n=20) published in the Journal of Clinical Pharmacology.
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