This is a 2 part study for patients with solid tumours. The purpose of Part A is to measure the amount of olaparib or its breakdown products in the bloodstream for up to 72 hours after eating 3 different breakfasts (high calorie, regular and none). In Part B Patients can take olaparib capsules daily and study assessments will be recorded for 6 months (minimum). Treatment can continue for as long as the patient is benefitting. Throughout the study patients will be monitored for any side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
32
400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
Allocated breakfast prior to dosing with 400mg olaparib capsules
Allocated breakfast prior to dosing with 400mg olaparib capsules
Research Site
Edegem, Belgium
Research Site
Leuven, Belgium
Research Site
Wilrijk, Belgium
Research Site
Amsterdam, Netherlands
Pharmacokinetics of Olaparib (Cmax and tmax)
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of maximum plasma olaparib concentration (Cmax) and time to reach maximum plasma concentration (tmax)
Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
Pharmacokinetics of Olaparib (AUC0-t)
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point (AUC0-t)
Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
Pharmacokinetics of Olaparib (AUC)
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC)
Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose
Pharmacokinetics of Olaparib Pharmacokinetics of Olaparib (CL/F, Vz/F, λz and t½)
Rate and extent of absorption of olaparib following single-dose olaparib by assessment of apparent clearance following oral administration (CL/F), apparent volume of distribution (Vz/F), terminal rate constant (λz), and terminal half-life (t½)
Time frame: Blood samples will be collected in each of the 3 treatment periods in Part A at these time points: pre-dose, 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72hours post dose.
Safety monitoring of Olaparib
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Allocated breakfast prior to dosing with 400mg olaparib capsules
Research Site
Maastricht, Netherlands
Research Site
Glasgow, United Kingdom
Research Site
Manchester, United Kingdom
Assessment of adverse events (AEs), graded by CTCAE (v4.0), physical examination, vital signs (including BP and pulse), standard 12-lead ECG and evaluation of laboratory parameters (clinical chemistry, haematology, and urinalysis). Assessment of physical examination, vital signs, ECG and evaluation of laboratory parameters will occur at screening, on the day before dosing in each treatment period and 30 days after last dose.
Time frame: AEs will be collected from signed informed consent up to 30-day post last dose in Part A. For patients in Part B, AE's will be collected until the final patient has completed 6 months in Part B, including 30 day follow up for those who discontinue