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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
Infusion
Carlumab
CNTO 888
Lead sponsor: Centocor Research & Development, Inc.
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 46
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Composite Response
timeFrame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
Secondary outcomes:
measure: Percentage of Participants With Objective Tumor Response
timeFrame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
measure: Progression-Free Survival (PFS)
timeFrame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
measure: Overall Survival (OS)
timeFrame: Week 8, 12, every 12 weeks up to 1 year after last dose of carlumab
measure: Percentage of Participants With Prostate Specific Antigen (PSA) Response
timeFrame: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
measure: Percentage of Participants With Urinary Crosslinked N-Telopeptide of Type I Collagen (NTx) Response
timeFrame: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4, 8, 12 after the last dose of carlumab
measure: Percentage of Participants With Pain Response
timeFrame: Up to 2 weeks before first dose, every 4 weeks after first dose, Week 4 after last dose of carlumab
measure: Time to Radiologic Response
timeFrame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
measure: Duration of Radiologic Response
timeFrame: Up to 4 weeks before first dose, every 12 weeks after first dose, Week 12 after last dose of carlumab
measure: Minimum Observed Serum Concentration (Cmin)
timeFrame: 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
measure: Maximum Observed Serum Concentration (Cmax)
timeFrame: 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
measure: Area Under the Serum Concentration Versus Time Curve Between 0 And 14 Days (AUC 0-14d)
timeFrame: Pre-dose, at the end of infusion, 2, 4 hr and 1 week after end of infusion for the first dose
measure: Half-life (t1/2)
timeFrame: 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
Other outcomes:
measure: Time to Worsening in Eastern Cooperative Oncology Group (ECOG) Status Score
timeFrame: Up to 2 weeks before first dose, pre-infusion, Week 4 after last dose of carlumab
Locations:
city: Orange City
country: United States
state: Florida
city: Ann Arbor
country: United States
state: Michigan
city: Charleston
country: United States
state: South Carolina
city: Antwerpen
country: Belgium
city: Bruxelles
country: Belgium
city: Wilrijk
country: Belgium
city: Moscow
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Birmingham
country: United Kingdom
city: Guildford
country: United Kingdom
city: Leeds
country: United Kingdom
city: Southampton
country: United Kingdom
city: Sutton
country: United Kingdom
Study officials:
affiliation: Centocor Research & Development, Inc.
name: Centocor Research & Development, Inc., PA, USA Clinical Trial
role: STUDY_DIRECTOR
References: