Open, non-randomized, radiolabelled, single centre study designed to characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg \[14C\]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
100mg Oral Dose
Research Site
London, United Kingdom
To characterize the metabolism, excretion and pharmacokinetics of a single oral dose of 100 mg [14C]-radiolabelled AZD2281 (KU-0059436) in patients with advanced or metastatic solid tumours, assessed by blood, urine and faecal sampling
Time frame: Various timepoints
To evaluate the safety and tolerability of AZD2281 (KU-0059436) by assessment of adverse events, laboratory findings and vital signs.
To provide plasma and excreta samples for future studies to investigate metabolite profiles and characterize human metabolites
To make a preliminary evaluation of clinical response as measured by objective tumour response rates at various timepoints.
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