NCT00249301

A Study of MLN8054 in Patients With Advanced Solid Tumors

An Open-Label, Dose Escalation Phase 1 Study of MLN8054, a Novel Aurora A Kinase Inhibitor, in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine (1) The side effects or toxicities of MLN8054;(2) The highest dose where side effects or toxicities are not too severe; (3) How MLN8054 is absorbed into the general blood circulation and eliminated from the body; and (4) The levels of MLN8054 in the blood that are needed to inhibit Aurora A kinase.

Conditions

• Breast Neoplasm
• Colon Neoplasm
• Pancreatic Neoplasm
• Bladder Neoplasm

Interventions

Type	Name	Description
DRUG	MLN8054	MLN8054 will be administered orally in multiple divided daily doses for 7 days to 21 consecutive days. A 14-day recovery period will follow each dosing period, regardless of its duration. MLN8054 will be supplied in capsules of 5 mg or 25 mg with dose strength expressed as the milligrams of active drug (free acid). MLN8054 will be given on an empty stomach. Patients will be instructed to take nothing by mouth except for water and prescribed medications for 2 hours before and 1 hour after each dose.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-01-01
• First posted: 2005-11-07
• Last updated: 2008-04-01

Locations

1 site across 1 country: United States