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A Phase I, two-arm, open-label study to evaluate the clinical drug-drug interaction potential of pralsetinib in combination with sensitive transporter substrates, sensitive CYP substrates, or a combined oral contraceptive in patients with advanced or metastatic solid tumors that are not responsive to standard therapies or for which there is no effective therapy

Trial Profile

A Phase I, two-arm, open-label study to evaluate the clinical drug-drug interaction potential of pralsetinib in combination with sensitive transporter substrates, sensitive CYP substrates, or a combined oral contraceptive in patients with advanced or metastatic solid tumors that are not responsive to standard therapies or for which there is no effective therapy

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 03 Oct 2024

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At a glance

  • Drugs Pralsetinib (Primary) ; Digoxin; Ethinylestradiol/norethisterone; Furosemide; Metformin; Midazolam; Montelukast; Rosuvastatin; Vitamin K; Warfarin
  • Indications Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Roche
  • Most Recent Events

    • 30 Sep 2024 Planned End Date changed from 30 Jun 2025 to 31 May 2025.
    • 04 Jun 2024 Planned End Date changed from 15 Oct 2024 to 30 Jun 2025.
    • 01 Feb 2023 Status changed from recruiting to active, no longer recruiting.

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