- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00992186
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
June 18, 2013 updated by: Centocor Research & Development, Inc.
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
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).
Study Overview
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 milligram/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.
Efficacy of the participants will be primarily evaluated by composite response.
Participants' safety will be monitored throughout the study.
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Antwerpen, Belgium
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Bruxelles, Belgium
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Wilrijk, Belgium
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Moscow, Russian Federation
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St Petersburg, Russian Federation
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St-Petersburg, Russian Federation
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Birmingham, United Kingdom
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Guildford, United Kingdom
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Leeds, United Kingdom
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Southampton, United Kingdom
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Sutton, United Kingdom
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Florida
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Orange City, Florida, United States
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Michigan
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Ann Arbor, Michigan, United States
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South Carolina
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Charleston, South Carolina, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Carlumab
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants With Composite Response
Time Frame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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The composite response is measured by change from Baseline in skeletal lesions, extra-skeletal lesions, and prostate specific antigen (PSA) values.
A participant is considered to have composite response, if 1 of the following responses occurs after the first dose of carlumab: (1) Complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST), (2) PSA response at 12 weeks and absence of skeletal and extra-skeletal progression or (3) Stable disease at 24 weeks defined as the absence of PSA, skeletal, or extra-skeletal progression.
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Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Objective Tumor Response
Time Frame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Objective response based on assessment of confirmed CR or PR according to RECIST.
CR defined as disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm).
PR defined as at least 30 percent (%) decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters.
Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.
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Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Progression-Free Survival (PFS)
Time Frame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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The PFS is defined as the time from the date of initiation of study treatment to the date of initial documented skeletal or extra-skeletal progressive disease, or date of death, whichever occurs first.
A participant is considered to have extra-skeletal disease progression if the disease has progressed as per the Response Evaluation Criteria in Solid Tumors (RECIST v1.1) criteria.
A participant is considered to have skeletal disease progression if they have 1 post-baseline bone scan demonstrating 2 or more new skeletal lesions compared to Baseline and confirmed by a second bone scan 6 to 12 weeks later or with evidence of clinical progression.
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Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Overall Survival (OS)
Time Frame: Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab
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The OS is defined as the time from the date of initiation of study treatment to death due to any cause.
Participants were followed for 1 year after the last administration of carlumab for survival or until the end of study, whichever occurs first.
For participants with unknown survival status as of the data cutoff date, OS was censored at the last date that the participant was known to be alive.
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Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab
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Percentage of Participants With Prostate Specific Antigen (PSA) Response
Time Frame: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
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The PSA response for participants with elevated PSA levels at Baseline (more than or equal to 5 nanogram per milliliter (ng/mL) is defined as at least a 50% reduction in PSA from the Baseline value, confirmed by a second PSA value measurement 3 or more weeks later.
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Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
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Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response
Time Frame: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
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Urinary NTx response for participants with elevated NTx level at Baseline (more than or equal to 50 nanomole per millimole (nmol/mmol)) is defined as a 30% reduction from Baseline NTx value, confirmed by a second NTx value 3 or more weeks later.
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Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
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Percentage of Participants With Pain Response
Time Frame: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab
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Pain response is defined as 2-point decrease from Baseline in 'worst pain' intensity score (item 3) on the Brief Pain Inventory (BPI) questionnaire.
The BPI is a nine-item questionnaire with 0 to 10 numeric rating scales in response to each item, where 0=No pain and 10=Pain as bad as you can imagine.
Measure can be scored by item, with lower scores being indicative of less pain or pain interference.
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Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab
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Time to Radiologic Response
Time Frame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Radiologic response based on assessment of confirmed CR or PR according to RECIST.
CR defined as disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm).
PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters.
Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.
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Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Duration of Radiologic Response
Time Frame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Radiologic response based on assessment of confirmed CR or PR according to RECIST.
CR defined as disappearance of all target lesions.
Any pathological lymph nodes must have reduction in short axis to less than 10 millimeter (mm).
PR defined as at least 30% decrease in sum of the diameters of the target lesions taking as reference the Baseline sum diameters.
Confirmed responses are those that persist on repeat imaging study for at least 4 weeks after initial documentation of response.
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Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
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Minimum Observed Serum Concentration (Cmin)
Time Frame: Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose
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Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose
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Maximum Observed Serum Concentration (Cmax)
Time Frame: Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose
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The maximum observed analyte concentration was measured.
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Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose
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Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)
Time Frame: Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose
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Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose
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Half-life (t1/2)
Time Frame: Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose
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The time measured for the serum concentration to decrease by one half.
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Pre-dose and at the end of infusion for each Dose; 2, 4 hour (hr) and 1 week after Dose 1; 2 hr after Dose 4; Week 1, 4, 8 and 12 post-last dose
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Status Score
Time Frame: Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab
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A worsening in ECOG performance status score was defined as greater than or equal to 1-point increase from Baseline.
Time to worsening is defined as the number of days from first dose to the first day of worsening in ECOG score, or death, whichever occurred first.
ECOG is a 5-point scale 0=Fully active, 1=Ambulatory, carry out work of sedentary nature, 2=Ambulatory, capable of all selfcare, 3=Capable of limited selfcare, confined to bed or chair more than 50% of waking hours, 4=Completely disabled, no selfcare, totally confined to bed or chair, 5=Dead.
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Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Centocor Research & Development, Inc., PA, USA Clinical Trial, Centocor Research & Development, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
July 1, 2011
Study Completion (Actual)
July 1, 2011
Study Registration Dates
First Submitted
September 29, 2009
First Submitted That Met QC Criteria
October 8, 2009
First Posted (Estimate)
October 9, 2009
Study Record Updates
Last Update Posted (Estimate)
June 24, 2013
Last Update Submitted That Met QC Criteria
June 18, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR015907
- 2009-011251-48
- CNTO888PCR2001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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