At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 56 enrolled
Drug / intervention
Olaparib tablet dosingdrug
Likely dose
Olaparib tablet dosing 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study of the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Renal Function or Renal Impairment
In Brief
A Phase 1 clinical trial evaluating Olaparib tablet dosing for Solid Tumours. Completed, enrolled 56 participants across 13 sites in 5 countries.
Detailed Summary
This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumours
CountriesBelgium, Denmark, France, Netherlands, United Kingdom
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartNov 2013
Primary CompletionMar 2015
Study CompletionFeb 2016
TodayJul 2026
First PostedJul 10, 2013
Enrollment StartNov 1, 2013
Primary CompletionMar 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.0 years ago
Interventions
Olaparib tablet dosingdrug
Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd