Study of the Effect of Rifampicin on the Pharmacokinetics (PK) of Multiple Doses of Cediranib in Patients With Solid Tumours
This trial is active, not recruiting.
|Start date||September 2008|
|End date||July 2009|
|Trial size||88 participants|
|Trial identifier||NCT00750841, 2008-002519-42, D8480C00029|
Phase I, open study to assess the effect of rifampicin, a marketed drug, on how the body handles the experimental drug cediranib in patients with advanced cancer.
|United States||No locations recruiting|
|Other Countries||No locations recruiting|
|Edmonton, Canada||Research Site||no longer recruiting|
|Montreal, Canada||Research Site||no longer recruiting|
|Dundee, United Kingdom||Research Site||no longer recruiting|
|Glasgow, United Kingdom||Research Site||no longer recruiting|
|London, United Kingdom||Research Site||no longer recruiting|
|Endpoint classification||pharmacokinetics study|
|Intervention model||single group assignment|
To assess the steady-state PK parameters of cediranib in the presence and absence of rifampicin
time frame: PK assessments to be taken until Day 28. Days 7 and 14 PK parameters used to assess the primary variables.
To assess the safety and tolerability of cediranib in the presence of rifampicin, by assessment of Adverse events (AEs) Laboratory findings, Vital signs, physical examination and Electrocardiogram.
time frame: Until study drug is discountinued
Male or female participants from 18 years up to 130 years old.
Inclusion Criteria: - Written informed consent - 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 Criteria: - Unstable brain/meningeal metastases - Biochemistry/haematology results outside of required ranges - History of significant GI impairment - Inadequate bone marrow reserve
|Official title||A Phase I, Open Label, Non-Randomised Study to Assess the Effect of Rifampicin on the Pharmacokinetics of Multiple Oral Doses of Cediranib (AZD2171, RECENTIN™), in Patients With Advanced Solid Tumours|
|Principal investigator||Michael Sawyer, MD|
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