NCT00052000

A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer

A Phase 1 Single Ascending Dose Trial of MLN2704 (DM1 Conjugated Monoclonal Antibody MLN591) in Subjects With Metastatic Androgen Independent Prostate Cancer

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (planned)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Not accepted

Summary

This is the first study of MLN2704 administered to humans. The purpose of the study is to determine the highest dose of MLN2704 that can be given safely to patients with prostate cancer, and to identify any side effects associated with taking the drug. This study will also evaluate how MLN2704 is taken up (absorbed), broken down (metabolized) and eliminated (excreted) by the body. This process is called pharmacokinetic analysis.

Detailed description

This is a Phase 1 open-label dose-escalating trial designed to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and pharmacokinetics of a single dose of MLN2704 in subjects with metastatic androgen-independent prostate cancer.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	MLN2704 (DM1 conjugated monoclonal antibody MLN591)

Timeline

• Start date: 2002-11-01
• First posted: 2003-01-22
• Last updated: 2007-03-01

Locations

2 sites across 1 country: United States