Advanced Solid Tumors Clinical Trial
Official title:
Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
The purpose of this study is to evaluate the effect of moderate or severe hepatic impairment on the single-dose pharmacokinetics of alisertib in adult participants with cancer.
The drug being tested in this study is called alisertib. Alisertib was tested to assess how
it was processed by the body in participants with advanced solid tumors or
relapsed/refractory lymphoma with varying degrees of liver function. This study also assessed
laboratory results and safety.
The study enrolled 36 participants. Participants were assigned to 1 of the 3 treatment groups
based on the status of their liver function: Normal hepatic function (Total bilirubin ≤ upper
limit of the normal range [ULN] and alanine aminotransferase [ALT] level ≤ ULN), moderate
hepatic impairment (Total bilirubin > 1.5-3 x ULN and ALT level = Any), or severe hepatic
impairment (Total bilirubin > 3 x ULN and ALT level = Any). All participants were
administered one 50 mg dose of alisertib on Day 1, Cycle 1. Alisertib was administered again
on Days 8 through 14 of Cycle 1, followed by a 14-day rest period. Doses administered on Days
8-14 were 50, 30, or 20 mg of alisertib, depending on hepatic function. Alisertib was then
continued at the same dose as in Cycle 1, Days 8-14 in 21-day cycles (7 days of alisertib
followed by a 14-day rest period) for up to 1 year (approximately 16 cycles).
This multicenter trial was conducted in USA only. The overall time to participate in this
study was up to 312 Days. Participants made multiple visits to the clinic including an
end-of-study visit 30 days after the last dose of study drug for a follow-up assessment.
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