AZD5305 hADME in Patients With Advanced Solid Malignancies
Trial Parameters
Brief Summary
This Phase I, open-label study aims to study to absolute bioavailability of Saruparib (AZD5305) and the absorption, distribution, metabolism and excretion (ADME) of \[14C\]-Saruparib in patients with advanced solid malignancies. This will be done on an inpatient basis in 2 parts (single-dose oral administration with radiolabeled microtracer in Part A, single-dose IV radiolabeled administration in Part B) during which samples will be obtained of plasma, urine, feces and vomitus (where applicable).
Eligibility Criteria
Inclusion Criteria: 1. Male or female ≥ 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place), at the time of signing the ICF. 2. Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, for which standard therapy does not exist or has proven ineffective or intolerable. 3. ECOG performance status of 0 or 1 with no deterioration over the 2 weeks prior to dosing. 4. Predicted life expectancy ≥ 12 weeks. 5. Adequate organ and marrow function as defined in the protocol 6. Willingness and ability to comply with study and follow-up procedures. 7. Able and willing to stay in hospital for specified residential periods following administration of Saruparib/\[14C\]-Saruparib 8. Regular bowel movements 9. Body weight within normal range specified in protocol 10. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participatin