Open-label, Randomised, Phase 2 Study in Patients With Advanced Solid Tumours to Determine Effect of Food Upon Pharmacokinetics of a Single Oral Dose of Cediranib (AZD2171, Recentin™), Followed by an Assessment of the Safety & Tolerability of Fixed and Individualised Daily Dosing
18 Years
N/A
Both
Cancer
Trial Information
Open-label, Randomised, Phase 2 Study in Patients With Advanced Solid Tumours to Determine Effect of Food Upon Pharmacokinetics of a Single Oral Dose of Cediranib (AZD2171, Recentin™), Followed by an Assessment of the Safety & Tolerability of Fixed and Individualised Daily Dosing
Inclusion Criteria:
- Clinical diagnosis of advanced solid tumour.
- Ability to eat a high fat breakfast
Exclusion Criteria:
- Poorly controlled high blood pressure.
- History of significant gastrointestinal problems
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Part A: Area Under Plasma Concentration-time Curve (AUC)
Outcome Description:
Area under plasma concentration-time curve from zero to infinity
Outcome Time Frame:
Measurements were collected up to 168 hours (following single dosing).
Safety Issue:
No
Principal Investigator
AstraZeneca AZD2171 Medical Science Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United Kingdom: Department of Health
Study ID:
D8480C00021
NCT ID:
NCT00306891
Start Date:
June 2006
Completion Date:
September 2008
Related Keywords:
- Cancer
- Advanced solid tumours
- Advanced cancer
- tumor
- tumour
- RECENTIN
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