At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 87 enrolled

Drug / intervention

Alisertibdrug

Likely dose

Alisertib 25 mgfrom 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/NCT00500903

NCT00500903Phase 1Completed

Compare CT.gov

An Open-Label, Dose Escalation Phase 1 Study of MLN8237, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors

Millennium Pharmaceuticals, Inc.·interventional·Posted Jul 13, 2007·Updated Mar 14, 2019

In Brief

A Phase 1 clinical trial evaluating Alisertib for Advanced Malignancies. Completed, enrolled 87 participants across 1 site.

Detailed Summary

To determine the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of MLN8237 when given by mouth (PO) for a minimum of 7 and a maximum of 21 consecutive days, followed by a 14-day recovery period.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsAdvanced Malignancies

CountriesUnited States

Collaborators--

Timeline

Phase 1CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMay 2007

First PostedJul 2007

Primary CompletionAug 2010

Study CompletionFeb 2011

TodayJul 2026

First PostedJul 13, 2007

Enrollment StartMay 15, 2007

Primary CompletionAug 1, 2010

Study CompletionFeb 23, 2011

TodayJul 2, 2026

Enrollment to primary: 3.2 yearsPosted 19.0 years ago

Interventions

Alisertibdrug

Alisertib (MLN8237) will be supplied in capsules of 5 or 25 mg and will be given on an empty stomach, with patients remaining nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose. Each dose will be given by mouth with 8 ounces of water for 7 to 21 consecutive days. A 14-day recovery period will follow each dosing period regardless of its duration.