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
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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).
Key facts
- Study ID
- NCT00992186
- Run by
- Centocor Research & Development, Inc.
- People needed
- 46
- Starts
- 2009-09-01
- Expected to finish
- 2011-07-01
- Last updated by the study team
- 2013-06-24
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Histological documentation of adenocarcinoma of the prostate
- Received at least 1 but no more than 2 prior docetaxel-based chemotherapy regimens and had disease progression following the last therapy
- Serum prostate specific antigen (PSA) greater than or equal to 5.0 nanogram/milliliter (ng/ml) within 4 weeks prior to the first dose of study agent
- Orchiectomy (surgery to remove one or both testicles) or testosterone less than 50 nanogram/deciliter by means of pharmacological/chemical castration within 4 weeks prior to the first dose of study agent
- At least 6 weeks from prior docetaxel chemotherapy regimen to first dose of study agent
You may not qualify if…
- Experience a hormonal treatment withdrawal response (including a lowering of PSA that was previously rising or symptomatic improvement)
- Known or symptomatic Central Nervous System metastases
- Residual toxicities resulting from previous therapy that are Grade 2 or more (except for alopecia)
- Known allergies, hypersensitivity, or intolerance to carlumab or its excipients or clinically significant reactions to chimeric or human proteins
- Vaccinated with live, attenuated vaccines within 4 weeks prior to the first dose of study agent
Where it is running
- Study site — Orange City, Florida, United States
- Study site — Ann Arbor, Michigan, United States
- Study site — Charleston, South Carolina, United States
- Study site — Antwerp, Belgium
- Study site — Brussels, Belgium
- Study site — Wilrijk, Belgium
- Study site — Moscow, Russia
- Study site — Saint Petersburg, Russia
- Study site — Birmingham, United Kingdom
- Study site — Guildford, United Kingdom
- Study site — Leeds, United Kingdom
- Study site — Southampton, United Kingdom
- Study site — Sutton, United Kingdom
Full record on ClinicalTrials.gov
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