CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 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.

Search/NCT01894243
NCT01894243Phase 1Completed
CompareCT.gov

An Open-label, Non-randomised, Multicentre, Comparative, Phase I Study to Determine the Pharmacokinetics, Safety and Tolerability of Olaparib Following a Single Oral 300 mg Dose to Patients With Advanced Solid Tumours and Normal Hepatic Function or Mild or Moderate Hepatic Impairment

AstraZeneca·interventional·Posted Jul 10, 2013·Updated Sep 13, 2019

In Brief

A Phase 1 clinical trial evaluating Olaparib tablet dosing for Solid Tumours. Completed, enrolled 31 participants across 12 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 hepatic impairment compared to patients with normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment or normal hepatic function continued access to olaparib after the PK phase and will provide additional safety data.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumours
CountriesCzechia, France, Netherlands, South Korea, United Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 10, 2013
Enrollment StartMar 13, 2014
Primary CompletionNov 29, 2016
Study CompletionMar 30, 2017
TodayJul 2, 2026
Enrollment to primary: 2.7 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