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A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS AND SAFETY OF DACOMITINIB IN PARTICIPANTS WITH SEVERELY IMPAIRED HEPATIC FUNCTION RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

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Trial Profile

A PHASE 1, OPEN-LABEL, SINGLE-DOSE, PARALLEL-GROUP STUDY TO EVALUATE THE PLASMA PHARMACOKINETICS AND SAFETY OF DACOMITINIB IN PARTICIPANTS WITH SEVERELY IMPAIRED HEPATIC FUNCTION RELATIVE TO PARTICIPANTS WITH NORMAL HEPATIC FUNCTION

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 28 Feb 2022

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At a glance

  • Drugs Dacomitinib (Primary)
  • Indications Non-small cell lung cancer; Squamous cell cancer
  • Focus Pharmacokinetics
  • Sponsors Pfizer

Most Recent Events

  • 23 Feb 2022 Results assessing the effect of hepatic impairment on the pharmacokinetics of dacomitinib, two dedicated studies (NCT01571388 and NCT03865446) conducted to inform optimal dosing, published in the Clinical Drug Investigation.
  • 17 Mar 2021 Results presented at the 122nd Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
  • 02 Nov 2019 Status changed from recruiting to completed.

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