Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor
Status:
Completed
Trial end date:
2021-02-24
Target enrollment:
Participant gender:
Summary
Phase 1, open-label, parallel group, PK, safety and tolerability study in patients with an
advanced solid tumor and either normal hepatic function (Group 1, n = 8) or moderate hepatic
impairment (Group 2, n = 8) according to the NCI-ODWG criteria. Patients in Group 1 and Group
2 may be enrolled in parallel, with preferential enrollment of Group 2 patients before Group
1 patients. The study will consist of 2 parts: a single-dose PK part (Part I) and a
continuous rucaparib treatment part (Part II).