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An Open-label, Single Dose, Multicenter Study to Evaluate the Pharmacokinetics and Safety of 50 mg Oral Buparlisib in Subjects With Moderate and Severe Renal Impairment Compared to Matched Control Healthy Volunteers.

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Trial Profile

An Open-label, Single Dose, Multicenter Study to Evaluate the Pharmacokinetics and Safety of 50 mg Oral Buparlisib in Subjects With Moderate and Severe Renal Impairment Compared to Matched Control Healthy Volunteers.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 14 Dec 2020

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At a glance

  • Drugs Buparlisib (Primary)
  • Indications Breast cancer; Gastrointestinal stromal tumours; Glioblastoma; Haematological malignancies; Male breast cancer; Malignant melanoma; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Oesophageal cancer; Prostate cancer; Solid tumours
  • Focus Pharmacokinetics
  • Sponsors Novartis

    • Most Recent Events

    • 25 Mar 2015 Status changed from recruiting to completed, as reported by ClinicalTrials.gov.
    • 29 Jan 2015 Planned End Date changed from 1 Nov 2014 to 1 Apr 2014 as per ClinicalTrials.gov record.
    • 29 Jan 2015 Planned primary completion date changed from 1 Nov 2014 to 1 Apr 2014 as per ClinicalTrials.gov record.

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