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.

Recruiting
Phase of Trial: Phase I

Latest Information Update: 19 Mar 2017

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

    • 09 Feb 2017 Planned End Date changed from 1 Jan 2017 to 4 Aug 2017.
    • 09 Feb 2017 Planned primary completion date changed from 1 Jan 2017 to 4 Aug 2017.
    • 23 Dec 2015 Status changed from not yet recruiting to recruiting as reported by ClinicalTrials.gov.
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