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

• Status: Completed
• Trial end date: 2011-07-01
• Target enrollment: 0
• Participant gender: Male

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor Research & Development, Inc.

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