Advanced Solid Tumors Clinical Trial
Official title:
An Open-label, Phase 1 Study of the Relative Bioavailability, Food Effect, Safety and Tolerability of MLN8237 in Patients With Advanced Solid Tumors
The purposes of this study were to estimate the relative (Rel) bioavailability (BA) of an oral solution (OS) formulation of alisertib in reference to a powder-in-capsule (PIC) formulation, to characterize the effect of food on the single-dose pharmacokinetics (PK) of alisertib OS and enteric-coated tablets (ECT), to characterize the multiple-dose safety, tolerability, and steady-state PK of alisertib administered as an OS, and to characterize the multiple-dose safety and tolerability of alisertib administered as an ECT.
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested
to treat people who have advanced solid tumors. This study will look at the relative
bioavailability (BA) (Part A), food effect and multiple-dose PK and safety of the oral
solution (OS) (Part B) and food effect and safety of the enteric-coated tablet (ECT)
formulation (Part C).
The study enrolled 53 patients (pts). Prior to initiation of Part A, 4 participants were
enrolled in a dose escalation cohort. Participants in the study received:
• Alisertib 15 mg to 50 mg orally In the first 2 cycles of all 3 parts of the study, a single
dose of alisertib was administered on Day 1 (PIC or OS in Part A [n=19 pts]; OS, in the fed
or fasted state, in Part B [n=6 pts]; ECT, in the fed or fasted state, in Part C [n=24 pts]),
In Part A, participants then continued on the PIC formulation at 40 mg BID for 7 days (Days 3
- 9). In Part B, participants continued on the OS formulation at a calculated dose
administered BID for 7 days (Days 3 - 9). In Part C, the ECT formulation was continued at 40
mg BID for 7 days (Days 3 - 9); however, dose escalation to 50 mg BID was permitted after
Cycle 1 based on tolerability and safety findings in the prior cycles. All participants took
doses at a gap of 12 hours each day for 7 days followed by a 14-day rest period in a 21-days
cycle for the remaining cycles.
This multi-center trial was conducted in the United States. The overall time to participate
in this study was 30 months. Participants made multiple visits to the clinic, and final
assessments were performed approximately 30 days after last dose of study drug.
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