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To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours

NCT01900028 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2016-10-17

No results posted yet for this study

Summary

This is a 3-part study in patients with advanced solid tumours: Part A will assess the effect of itraconazole on the PK parameters of olaparib and will determine the effect of olaparib on the QT interval following single oral dosing; Part B will determine the effect of olaparib on the QT Interval following multiple oral dosing; Part C will allow patients continued access to olaparib after the PK and QT phases and will provide for additional safety data collection. A total of 48 patients are planned to be enrolled; at least 42 evaluable patients will be required to complete the study. Patients will participate as a single cohort in all parts of the study.

Conditions

Interventions

PROCEDURE

Pharmacokinetic sampling

Blood samples taken pre and post dosing with olaparib+/- itraconazole

DRUG

Olaparib tablet dosing

Olaparib tablets: Part A 100mg od, days 1 and 9 only. Part B 10x300mg doses over 5 days (300mg bd).

DRUG

Itraconazole

Itraconazole 200mg od Part A days 5 to 11 only

Sponsors & Collaborators

Principal Investigators

  • Anitra Fielding · AstraZeneca Senior Research Physician

  • Ruth Plummer, Prof · Northern Centre for Cancer Care, Newcastle Upon Tyne

Study Design

Allocation
NA
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2014-04-30
Completion
2016-09-30

Countries

  • Belgium
  • Denmark
  • Netherlands
  • United Kingdom

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 NCT01900028 on ClinicalTrials.gov