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

Phase 1

Completed

• Conditions: Prostate Cancer

• Registration Number: NCT00052000
• Lead Sponsor: Millennium Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2003-01-21
• Study First Submitted QC: 2003-01-21
• Study First Posted: 2003-01-22
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-28
• Last Update Posted: 2007-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 29

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (2)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

The Sidney Kimmel Comprehensive Cancer Center @ Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States