A Study of the Safety and Efficacy of Single-agent CNTO 888 (an Anti CC-Chemokine Ligand 2 [CCL2]) in Patients With Metastatic Prostate Cancer
The purpose of this study is to determine the safety and effectiveness of the study drug CNTO 888 in patients with metastatic castrate-resistant prostate cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open-label, Multicenter, Phase 2 Study of Single-agent CNTO 888 (an Anti-CCL2 Monoclonal Antibody) for the Treatment of Patients With Metastatic Castrate-Resistant Prostate Cancer|
- To determine the composite response in patients with metastatic Castrate-Resistant Prostate Cancer (CRPC) who receive single-agent 15 mg/kg CNTO 888 every 2 weeks. [ Time Frame: 3-6 months ] [ Designated as safety issue: No ]
- Objective response rate determined as complete response and partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) guidelines [ Time Frame: Patients will be treated every 2 weeks ] [ Designated as safety issue: No ]
- Progression Free Survival [ Time Frame: Patients will be treated every 2 weeks ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: Patients will be treated every 2 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||July 2011|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
CNTO888 15mg/kg intravenously every 2 weeks until disease progression.
15mg/kg intravenously every 2 weeks until disease progression.
CNTO 888 is an antibody. Antibodies are substances in the body that are involved in many biological processes. CNTO 888 works by blocking a protein called "CC-Chemokine Ligand 2 (CCL2)". In research studies, CCL2 has been shown to increase the growth of new blood vessels, which help the tumor to survive. When new blood vessels do not grow, tumors cannot get the food or oxygen they need to grow. This study will evaluate the effect CCL2 has on prostate cancer growth. CNTO 888 is an experimental drug. Metastatic castrate-resistant prostate cancer is a type of prostate cancer that spreads from the prostate to other parts of the body. This kind of prostate cancer does not respond to medications that are typically used to lower hormone levels to slow the growth of cancer in the prostate. Patients enrolled in the study will receive 15mg/kg of CNTO888 intravenously (into the vein) every two weeks, until disease progression. Patients who experience toxicities may have their dose lowered to 10 mg/kg or discontinued. Safety assessments will be performed throughout the study including laboratory test evaluations, vital signs (e.g. blood pressure) and monitoring for the occurence and severity of adverse events. 15mg/kg once every 2 weeks until disease progression. Patient can have dose reduced to 10mg/kg once every 2 weeks if unresolved toxicity is experienced with 15mg/kg dose level.
|United States, Florida|
|Orange City, Florida, United States|
|United States, Michigan|
|Ann Arbor, Michigan, United States|
|United States, South Carolina|
|Charleston, South Carolina, United States|
|Moscow, Russian Federation|
|St Petersburg, Russian Federation|
|St-Petersburg, Russian Federation|
|Birmingham, United Kingdom|
|Guildford, United Kingdom|
|Leeds, United Kingdom|
|Southampton, United Kingdom|
|Sutton, United Kingdom|
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|