Tracking Information
Start Date ICMJE | September 2009 |
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Primary Completion Date | |
Current Primary Outcome Measures ICMJE (submitted: October 8, 2009) | 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 ] |
Original Primary Outcome Measures ICMJE | Same as current |
Change History | Complete list of historical versions of study NCT00992186 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: October 8, 2009) |
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Original Secondary Outcome Measures ICMJE | Same as current |
Descriptive Information
Brief Title ICMJE | 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 |
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Official Title ICMJE | 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 |
Brief Summary | 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. |
Detailed Description | 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 occurance 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. |
Study Phase | Phase II |
Study Type ICMJE | Interventional |
Study Design ICMJE | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Condition ICMJE | Prostate Cancer |
Intervention ICMJE | Drug: CNTO888 15mg/kg intravenously every 2 weeks until disease progression. |
Study Arms / Comparison Groups | 001: Experimental CNTO888 15mg/kg intravenously every 2 weeks until disease progression. Intervention: Drug: CNTO888 |
Recruitment Information
Estimated Enrollment ICMJE | 43 | ||||
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Estimated Completion Date | November 2011 | ||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Male | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE |
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Location Countries ICMJE | United States, Belgium, Russian Federation, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00992186 | ||||
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Responsible Party | Director, Clinical Research, Centocor | ||||
Study ID Numbers ICMJE | CR015907, 2009-011251-48 | ||||
Study Sponsor ICMJE | Centocor, Inc. | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Centocor, Inc. |