study of the effect of rifampicin on the pharmacokinetics (PK) of multiple doses of cediranib in patients with solid tumours
Study identifier:D8480C00029
ClinicalTrials.gov identifier:NCT00750841
EudraCT identifier:2008-002519-42
CTIS identifier:N/A
Recruitment Complete
Official Title
A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTIN™), in Patients with Advanced Solid Tumours
Medical condition
Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
cediranib
Sex
All
Actual Enrollment
64
Study type
Interventional
Age
18 Years - 130 Years
Date
Study Start Date: 09 Sept 2008
Primary Completion Date: 30 Jul 2009
Estimated Study Completion Date: 31 Dec 2024
Study design
Allocation: Non-randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Sept 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Cediranib alone, followed by cediranib plus rifampicin, followed by cediranib alone. | Drug: cediranib 45 mg cediranib once daily from Days 1-7; cediranib 45 mg plus 600 mg rifampicin from Days 8-14; 45 mg cediranib once daily from Days 15-28; from Day 29 patients may continue on 45 mg cediranib or dose reduce. Other Name: RECENTIN |
Contacts
Investigators
Principal Investigator
Michael Sawyer
Cross Cancer Institute, Edmonton, AB, Canada
