Status:
COMPLETED
Phase 1 PK Study of Cediranib in Single and Multiple Doses in Hepatically Impaired Patients With Solid Tumours
Lead Sponsor:
AstraZeneca
Conditions:
Advanced Cancer
Hepatic Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
To determine how patients with advanced cancer and various degrees of hepatic impairment will metabolise Cediranib.
Eligibility Criteria
Inclusion
- Written informed consent
- Advanced solid tumour (not prostate cancer) for which no standard therapy exists
- WHO performance status 0-2
- Bilirubin levels within the target range
Exclusion
- Unstable brain/meningeal metastases
- Inadequate bone marrow reserve
- Biochemistry/haematology results outside of required ranges
- History of significant GI impairment
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00621725
Start Date
January 1 2008
End Date
January 1 2014
Last Update
July 15 2014
Active Locations (3)
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1
Research Site
København Ø, Denmark
2
Research Site
Nijmegen, Netherlands
3
Research Site
Rotterdam, Netherlands