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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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)
Research Site
Hamilton, Canada
Research Site
Toronto, Canada
Research Site
Vancouver, Canada
Research Site
Copenhagen, Denmark
Research Site
Herlev, Denmark
To assess the steady-state PK parameters of cediranib in the presence and absence of ketoconazole.
Time frame: PK assessments to be taken until Day 42. Days 7 and 10 PK parameters used to assess the primary variables.
Safety and tolerability of cediranib in the presence of ketoconazole by assessment of Adverse events (AEs) Laboratory findings,Vital signs, physical examination and Electrocardiogram.
Time frame: Until study drug is discountinued
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