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.
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
- 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.