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Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor

pharmaand GmbH · 2018
ClinicalTrials.gov · Datasets · License: Public Domain · 2018
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neoplasms
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).
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