Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052000
Status:
COMPLETED
Last Update Posted:
2007-03-01
First Post:
2003-01-21
Brief Title:
A Trial of MLN2704 in Subjects With Metastatic Androgen Independent Prostate Cancer
Sponsor:
Millennium Pharmaceuticals Inc
Organization:
Millennium Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 1 Single Ascending Dose Trial of MLN2704 DM1 Conjugated Monoclonal Antibody MLN591 in Subjects With Metastatic Androgen Independent Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2007-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None