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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

NCT02093351 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2019-10-02

Study results available
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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

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Tsveta Milenkova · AstraZeneca

  • Ruth Plummer · Sir Bobby Robson Cancer Trials Research Centre

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-01
Primary Completion
2015-04-30
Completion
2019-04-29

Countries

  • Belgium
  • Denmark
  • France
  • Netherlands
  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02093351 on ClinicalTrials.gov