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

Centocor Ortho Biotech

Status and phase

Completed

Phase 2

Conditions

Prostate Cancer

Treatments

Drug: Carlumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00992186

CNTO888PCR2001

CR015907

2009-011251-48

Details and patient eligibility

About

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).

Full 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.

Enrollment

46 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

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