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A Phase 1, Open-label, Single-dose, Multicenter, Parallel Group Study to Assess the Pharmacokinetics and Safety of Alpelisib (BYL719) in Subjects With Hepatic Impairment Compared to Matched Healthy Control Subjects.

Trial Profile

A Phase 1, Open-label, Single-dose, Multicenter, Parallel Group Study to Assess the Pharmacokinetics and Safety of Alpelisib (BYL719) in Subjects With Hepatic Impairment Compared to Matched Healthy Control Subjects.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 16 Jan 2020

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At a glance

  • Drugs Alpelisib (Primary)
  • Indications Breast cancer; Colorectal cancer; Gastrointestinal stromal tumours; Head and neck cancer; Multiple myeloma; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Solid tumours; Uveal melanoma
  • Focus Pharmacokinetics
  • Sponsors Novartis Pharmaceuticals Corporation

Most Recent Events

  • 03 May 2018 Status changed from recruiting to completed.
  • 16 Oct 2017 Planned End Date changed from 25 Sep 2017 to 15 Jan 2018.
  • 16 Oct 2017 Planned primary completion date changed from 25 Sep 2017 to 15 Jan 2018.

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