Pharmacokinetic and Safety Study of Pixantrone in Patients With Metastatic Cancer and Hepatic Impairment
Status:
Unknown status
Trial end date:
2018-02-01
Target enrollment:
Participant gender:
Summary
This study will be conducted in patients with metastatic cancer and either moderate, severe,
or no hepatic impairment who have failed other antineoplastic therapies or for whom there is
no standard therapy. The study will be conducted in two stages. Using an existing pixantrone
population pharmacokinetic (PPK) model, a model-based strategy will be used to evaluate the
findings from the first stage of the study conducted in patients with moderate hepatic
impairment and matched controls. The PPK evaluation will be completed prior to enrolling
patients with severe hepatic impairment and additional matched controls during the second
stage of the study. Patients with hepatic impairment will be paired with matched control
patients with normal hepatic function, matched on gender, age, and body surface area (BSA).