Study Assessing Metabolism, Excretion and Pharmacokinetics of a Poly (ADP-Ribose) Polymerase (PARP) Inhibitor in Patients With Solid Metastatic Tumours

Open, Non-Randomized, Single Centre Phase I Study to Assess the Metabolism, Excretion and Pharmacokinetics of a Single Oral 100 mg Dose of [14C]-AZD2281 (KU-0059436) in Patients With Advanced or Metastatic Solid Tumours Refractory to Standard Treatments

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.

Inclusion Criteria:

• Histologically confirmed advanced or metastatic tumour, refractory to standard therapies

Exclusion Criteria:

• Anti-cancer therapy including chemotherapy, radiotherapy (excluding palliative radiotherapy), endocrine therapy, immunotherapy or use of other investigational agents within 4 weeks prior to study entry.
• Patients may continue the use of LHRH agonists for cancer, bisphosphonates for bone disease and corticosteroids provided the dose is stable before and during the study.
• Females will be able to continue to take hormone replacement therapy