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
NCT ID: NCT00992186
Last Updated: 2013-06-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2009-09-30
2011-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Carlumab
Carlumab
Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Carlumab
Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Centocor Research & Development, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Centocor Research & Development, Inc., PA, USA Clinical Trial
Role: STUDY_DIRECTOR
Centocor Research & Development, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orange City, Florida, United States
Ann Arbor, Michigan, United States
Charleston, South Carolina, United States
Antwerp, , Belgium
Brussels, , Belgium
Wilrijk, , Belgium
Moscow, , Russia
Saint Petersburg, , Russia
Birmingham, , United Kingdom
Guildford, , United Kingdom
Leeds, , United Kingdom
Southampton, , United Kingdom
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2009-011251-48
Identifier Type: -
Identifier Source: secondary_id
CNTO888PCR2001
Identifier Type: -
Identifier Source: secondary_id
CR015907
Identifier Type: -
Identifier Source: org_study_id