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Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours

NCT01929603 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-01-16

No results posted yet for this study

Summary

This is a 2-part study in patients with advanced solid tumours. Part A will investigate the effect of rifampicin on the PK parameters of olaparib in patients; Part B will allow patients continued access to olaparib after the PK phase and will provide additional safety data.

Conditions

Interventions

PROCEDURE

Pharmacokinetic sampling

Blood sampling to measure olaparib, rifampicin and 4β-hydroxycholesterol

DRUG

Rifampicin

Rifampicin (CYP inducer) 600mg taken once daily from Day 5 to Day 14 (Part A)

DRUG

Olaparib tablet dosing

Olaparib 300mg tablet taken on Days 1 and 14 (Part A). Part B dosing is 300mg olaparib bi-daily

Sponsors & Collaborators

Principal Investigators

  • Anitra Fielding · AstraZeneca Senior Research Physician

  • Luc Dirix · GZA Ziekenhuizen Campus Sint-Augustinus

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-05-31
Completion
2016-11-30

Countries

  • Belgium
  • Netherlands

Study Locations

More Related Trials

Entities

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 NCT01929603 on ClinicalTrials.gov