NCT00677170

Study of MLN4924 in Adult Patients With Nonhematologic Malignancies

An Open-Label, Dose Escalation, Phase I Study of MLN4924, a Novel Inhibitor of Nedd8-Activating Enzyme, in Adult Patients With Nonhematologic Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter, Phase 1, dose escalation study of MLN4924 in adult patients with nonhematologic malignancies. This study will be the first to administer MLN4924 in humans. The patient population will consist of adults with any form of nonhematologic malignancy for which standard, curative, life prolonging, or palliative treatment does not exist or is no longer effective.

Conditions

• Advanced Nonhematologic Malignancies

Interventions

Type	Name	Description
DRUG	MLN4924	IV dose escalation for 5 consecutive days followed by a rest period of 16 days for a 21 day cycle. Treated may continue until disease progression or unacceptable toxicity develops.

Timeline

• Start date: 2008-04-01
• Primary completion: 2012-02-01
• Completion: 2012-12-01
• First posted: 2008-05-14
• Last updated: 2013-07-16

Locations

3 sites across 1 country: United States