CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 53 enrolled
Drug / intervention
Alisertibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00962091
NCT00962091Phase 1Completed
CompareCT.gov

An Open-label, Phase 1 Study of the Relative Bioavailability, Food Effect, Safety and Tolerability of MLN8237 in Patients With Advanced Solid Tumors

Millennium Pharmaceuticals, Inc.·interventional·Posted Aug 19, 2009·Updated Mar 12, 2019

In Brief

A Phase 1 clinical trial evaluating Alisertib for Advanced Solid Tumors. Completed, enrolled 53 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Solid Tumors
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 19, 2009
Enrollment StartSep 25, 2009
Primary CompletionDec 28, 2011
Study CompletionJul 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.9 years ago

Interventions

Alisertibdrug

Alisertib OS Alisertib PIC Alisertib PIC