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

Sponsor
AstraZeneca
Study ID
NCT02093351
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumours

Eligibility Criteria

Sex
ALL
Age
18 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Olaparib — DRUG
    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)
  • Tamoxifen — DRUG
    60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31
  • Anastrozole — DRUG
    1mg Anastrozole once daily Day 10 - Day 24
  • Letrozole — DRUG
    2.5mg Letrozole once daily Day 10 - Day 43
  • Pharmacokinetic sampling — PROCEDURE
    Blood sampling over 12-24 hour period for pharmacokinetic analysis

Study Details

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.

Key Dates

Start date
Sep 1, 2014
Status verified
Sep 2019
Primary completion
Apr 30, 2015
Completion
Apr 29, 2019

Study Design

Enrollment
79 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohort 1 - Tamoxifen
    Olaparib-alone Steady state PK, Tamoxifen-alone steady state PK, Combined olaparib and Tamoxifen steady state PK.
  • Experimental: Cohort 2 - Anastrozole
    Olaparib-alone Steady state PK, Anastrozole-alone steady state PK, Combined olaparib and Anastrozole steady state PK.
  • Experimental: Cohort 3 - Letrozole
    Olaparib-alone Steady state PK, Letrozole-alone steady state PK, Combined olaparib and Letrozole steady state PK.

Primary Outcome Measure

Effect of Olaparib on Exposure to Tamoxifen - Cmax ss [ Time Frame: Pre-dose and at 1, 2, 4, 5, 6, 8, 12 and 24 hours post-dose on Day 26 and Day 31 ]

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