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D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

NCT01851265 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-08-28

No results posted yet for this study

Summary

This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.

Conditions

Interventions

DRUG

Olaparib

400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.

OTHER

Dietary Fasted

Allocated breakfast prior to dosing with 400mg olaparib capsules

OTHER

Dietary standard

Allocated breakfast prior to dosing with 400mg olaparib capsules

OTHER

Dietary High Fat

Allocated breakfast prior to dosing with 400mg olaparib capsules

Sponsors & Collaborators

Principal Investigators

  • Anitra Fielding · AstraZeneca Senior Research Physician

  • Christian Rolfo · UZ Antwerpen

  • Wendy Bannister · AstraZeneca Study Statistician

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2013-07-04
Primary Completion
2013-10-18
Completion
2017-06-06

Countries

  • Belgium
  • 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 NCT01851265 on ClinicalTrials.gov