NCT02093351

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

An Open-Label, Non-randomised, Parallel Group, Multicentre, Phase I Study to Assess the Safety and Effect of Olaparib at Steady State on the Pharmacokinetics of the Anti-hormonal Agents Anastrozole, Letrozole and Tamoxifen at Steady State, and the Effect of the Anti-hormonal Agents on Olaparib, Following Administration in Patients With Advanced Solid Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label 2-part Phase I study in patients with advanced solid tumours. Part A of the study (mandatory) will assess the effect of olaparib on the pharmacokinetics (PK) of anastrozole, letrozole and tamoxifen and vice versa; Part B will allow patients (if eligible) continued access to olaparib after the PK phase and will provide additional safety data.

Conditions

• Solid Tumours

Interventions

Type	Name	Description
DRUG	Olaparib	2 x 150mg tablets, twice daily Day 1-5, and Day 27 onwards (Cohort 1), Day 20 onwards (Cohort 2) or Day 39 onwards (Cohort 3)
DRUG	Tamoxifen	60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31
DRUG	Anastrozole	1mg Anastrozole once daily Day 10 - Day 24
DRUG	Letrozole	2.5mg Letrozole once daily Day 10 - Day 43
PROCEDURE	Pharmacokinetic sampling	Blood sampling over 12-24 hour period for pharmacokinetic analysis

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-04-30
• Completion: 2019-04-29
• First posted: 2014-03-21
• Last updated: 2019-10-02
• Results posted: 2016-06-01

Locations

14 sites across 5 countries: Belgium, Denmark, France, Netherlands, United Kingdom