A Pharmacokinetic Study of AMG 386 in Cancer Subjects With Normal and Impaired Renal Function
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
This is a phase 1, open-label pharmacokinetic study where up to 40 subjects with advanced
solid tumors (up to 6-10 with normal renal function and up to 18-30 with varying degrees of
renal dysfunction) will receive weekly doses of AMG 386 intravenously. The primary objective
is to evaluate the pharmacokinetics (PK) of single agent AMG 386 in subjects with various
degrees of renal function. Once the AMG 386 PK characterization is complete in the first 5
weeks of the study, all subjects will be allowed to continue to receive AMG 386 weekly only
or subjects in group 1, 2 or 3 can opt to receive AMG 386 weekly in combination with
paclitaxel until disease progression, unacceptable toxicity or withdrawal of consent.