This is a 2-part study in patients with advanced solid tumours. Part A will investigate the PK of olaparib in patients with mild or moderate renal impairment compared to patients with normal renal function; Part B will allow eligible study patients continued access to olaparib after the PK phase and will provide additional safety data.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
56
Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd
Research Site
Brussels (Jette), Belgium
Research Site
Edegem, Belgium
Research Site
Leuven, Belgium
Research Site
Liège, Belgium
Cmax of Olaparib
Maximum plasma drug concentration of olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
AUC of Olaparib
Area under plasma concentration-time curve from zero to infinity of olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
AUC0-t of Olaparib
Area under plasma concentration-time curve from zero to the last measurable time point of olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Tmax of Olaparib
Time to reach maximum plasma concentration of olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
Vz/F of Olaparib
Apparent volume of distribution of olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
CL/F of Olaparib
Apparent plasma clearance of olaparib
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose
CLR of Olaparib
Renal clearance of olaparib, calculated as the ratio of amount of drug excreted over 24 hours to AUC0-24
Time frame: Part A: Day 1, 0-12 hours and 12-24 hours post-dose
t1/2 of Olaparib
Terminal half-life of olaparib
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Research Site
Wilrijk, Belgium
Research Site
Herlev, Denmark
Research Site
København Ø, Denmark
Research Site
Bordeaux, France
Research Site
Dijon, France
Research Site
Amsterdam, Netherlands
...and 3 more locations
Time frame: Part A: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, 72 and 96 hours post-dose