Prostate CancerPhase 2NCT00992186
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
A Phase 2 study testing Carlumab in people with Prostate Cancer, run by Centocor Research & Development, Inc. at 13 sites in 4 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Carlumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Sep 2009to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United Kingdom5 sites
Study site
Birmingham
Study site
Guildford
Study site
Leeds
Study site
Southampton
Study site
Sutton
United States3 sites
Study site
Ann Arbor, Michigan
Study site
Charleston, South Carolina
Study site
Orange City, Florida
About this study
Official title: 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).
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Carlumab
- Keywords
- Prostate cancer, Infusion, Carlumab, CNTO 888
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarlumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Carlumab | Experimental | Not described Receives: Drug: Carlumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Composite Response
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.
Measured: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
Secondary outcomes (12)
Percentage of Participants With Objective Tumor Response
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.
Measured: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
Progression-Free Survival (PFS)
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.
Measured: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
Overall Survival (OS)
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.
Measured: Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab
Percentage of Participants With Prostate Specific Antigen (PSA) Response
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.
Measured: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response
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.
Measured: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
Percentage of Participants With Pain Response
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.
Measured: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab
Time to Radiologic Response
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.
Measured: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
Duration of Radiologic Response
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.
Measured: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
Minimum Observed Serum Concentration (Cmin)
Measured: 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
Maximum Observed Serum Concentration (Cmax)
The maximum observed analyte concentration was measured.
Measured: 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
Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)
Measured: Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose
Half-life (t1/2)
The time measured for the serum concentration to decrease by one half.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centocor Research & Development, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Centocor Research & Development, Inc., PA, USA Clinical Trial, Study director, Centocor Research & Development, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992186
- Sponsor's protocol ID
- CR015907
- Other IDs
- 2009-011251-48, CNTO888PCR2001, 2009
- Status last verified
- Jun 2013
- First submitted
- 29 Sep 2009
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00992186
- Acronym / sponsor ID
- CR015907
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, Infusion, Carlumab, CNTO 888
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Centocor Research & Development, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 Oct 2009 (estimated)
- Results
- Posted 20 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carlumab | Experimental | Drug: Carlumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarlumabCarlumab 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. | Drug | Carlumab |
Primary outcome
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
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.
12 secondary outcomes
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
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
Overall Survival (OS)
Time frame: Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab
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
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
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
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
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
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Centocor Research & Development, Inc., PA, USA Clinical Trial study director
Centocor Research & Development, Inc.
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carlumab in people with Prostate Cancer, run by Centocor Research & Development, Inc. at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United Kingdom, United States, Belgium, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.