Ignite Creation Date:
2024-05-05 @ 9:56 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00992186
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2009-09-29
Brief Title:
A Study of the Safety and Efficacy of Single-agent Carlumab an Anti-Chemokine Ligand 2 CCL2 in Participants With Metastatic Castrate-Resistant Prostate Cancer
Sponsor:
Centocor Research Development Inc
Organization:
Centocor Research Development Inc
Study Overview
Official Title:
An Open-Label Multicenter Phase 2 Study of Single-Agent CNTO 888 an Anti-CCL2 Monoclonal Antibody for the Treatment of Subjects With Metastatic Castrate-Resistant Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2013-06
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:
The purpose of this study is to determine the safety and effectiveness of the study drug carlumab in participants with metastatic castrate-resistant prostate cancer cancer of the gland that makes fluid that aids movement of sperm
Detailed Description:
This is an open-label all people know the identity of the intervention multicenter trial conducted in more than one center in participants with metastatic castrate-resistant prostate cancer The trial consists of 3 phases screening period treatment period of approximately 4 months and a follow-up period Week 1 4 8 and 12 after the last dose of up to 12 weeks after the administration of last dose The participants will receive carlumab at the dose of 15 milligramkilogram mgkg by intravenous into a vein infusion a fluid or a medicine delivered into a vein by way of a needle at a constant rate over a 90 minute period once every 2 weeks until disease progression Efficacy of the participants will be primarily evaluated by composite response Participants safety will be monitored throughout the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CNTO888PCR2001 | None | None | None |
| 2009-011251-48 | None | None | None |