Status:
COMPLETED
Phase 1 Study of the Effect of Ketoconazole on the PK of Multiple Doses of Cediranib in Patients With Solid Tumours
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Unstable brain/meningeal metastases
- Biochemistry/haematology results outside of required ranges
- History of significant GI impairment
- Inadequate bone marrow reserve
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00750425
Start Date
August 1 2008
End Date
January 1 2011
Last Update
March 10 2011
Active Locations (5)
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1
Research Site
Hamilton, Canada
2
Research Site
Toronto, Canada
3
Research Site
Vancouver, Canada
4
Research Site
Copenhagen, Denmark