Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
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
2 other identifiers
interventional
46
2 countries
5
Brief Summary
Phase I, open study to assess the effect of ketoconazole, a marketed drug, on the way the body handles the experimental drug cediranib, in patients with advanced cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2008
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 8, 2008
CompletedFirst Posted
Study publicly available on registry
September 10, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2011
CompletedMarch 10, 2011
March 1, 2011
8 months
September 8, 2008
March 9, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
Secondary Outcomes (1)
Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.
Until study drug is discountinued
Study Arms (1)
1
EXPERIMENTALCediranib alone, followed by cediranib plus ketoconazole, followed by cediranib alone
Interventions
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)
Eligibility Criteria
You may qualify if:
- Written informed consent
- Histological or cytological confirmation of advanced solid tumour (with the exception of prostate cancer), which is refractory to standard therapies or for which no standard therapy exists.
- Estimated life expectancy of at least 8 weeks
- WHO performance status (PS) 0-2.
You may not qualify if:
- Unstable brain/meningeal metastases
- Biochemistry/haematology results outside of required ranges
- History of significant GI impairment
- Inadequate bone marrow reserve
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (5)
Research Site
Hamilton, Canada
Research Site
Toronto, Canada
Research Site
Vancouver, Canada
Research Site
Copenhagen, Denmark
Research Site
Herlev, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jane Roberston
AstraZeneca Aderley Park
- PRINCIPAL INVESTIGATOR
Dr U Lassen, MD PhD
The Finsen Center, Copenhagen, Denmark
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 8, 2008
First Posted
September 10, 2008
Study Start
August 1, 2008
Primary Completion
April 1, 2009
Study Completion
January 1, 2011
Last Updated
March 10, 2011
Record last verified: 2011-03