Pharmacokinetics of Oral Alisertib (MLN8237) in Adult Patients With Advanced Solid Tumors or Relapsed/Refractory Lymphoma With Varying Degrees of Hepatic Function
The drug being tested in this study is called alisertib. Alisertib is being tested to assess how it is processed by the body in participants with advanced solid tumors or relapsed/refractory lymphoma with varying degrees of liver function. This study will also assess laboratory results and safety.
The study will enroll approximately 48 participants. Participants will be 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 will be administered one 50 mg dose of alisertib on Day 1, Cycle 1. Alisertib will be administered again on Days 8 through 14 of Cycle 1, followed by a 14-day rest period. Doses administered on Days 8-14 will be 50, 30, or 20 mg of alisertib, depending on hepatic function. Alisertib may then be 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 will be conducted in USA only. The overall time to participate in this study is up to 13 months unless it is determined by the investigator, with agreement by the sponsor, that a participant would derive clinical benefit from continued treatment beyond 12 months. Participants will make up to 51 visits to the clinic including an end-of-study visit 30 days after the last dose of study drug for a follow-up assessment.