Phase 1 study of the effect of ketoconazole on the PK of multiple doses of cediranib in patients with solid tumours
Study identifier:D8480C00020
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTINÔ), in Patients With Advanced Solid Tumours
Medical condition
Advanced Solid Tumors
Phase
Phase 1
Healthy volunteers
No
Study drug
cediranib (RECENTIN TM, AZD2171)
Sex
All
Actual Enrollment
46
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Aug 2008
Primary Completion Date: 01 Apr 2009
Study Completion Date: 01 Jan 2011
Study design
Allocation: N/A
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Verification:
Verified 01 Nov 2013 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
Loading...
No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 Cediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone | Drug: cediranib (RECENTIN TM, AZD2171) 20 mg cediranib once daily from Days 1 to 7; then 20 mg cediranib plus 400 mg ketoconazole from Days 8-10; then 20 mg cediranib once daily from Days 11-23. At Day 24 patients may dose escalate to 30 mg tablet once daily providing the treatment is well tolerated (this may be escalated up to 45 mg if the 30mg dose is tolerated for a minimum of 14 days) |
Contacts
Investigators
Principal Investigator
Jane Roberston
AstraZeneca Aderley Park
