NCT00537381

An Efficacy and Safety Study of Intetumumab (CNTO 95) in Participants With Metastatic Hormone Refractory Prostate Cancer

A Randomized, Double-blind, Multicenter, Phase 2 Study of a Human Monoclonal Antibody to Human av Integrins (CNTO 95) in Combination With Docetaxel for the First-Line Treatment of Subjects With Metastatic Hormone Refractory Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 131 (actual)
• Sponsor: Centocor, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effects of intetumumab when given in combination with docetaxel and prednisone to participants with metastatic (spread of cancer cells from one part of the body to another) hormone-refractory (not responding to treatment) prostate cancer (abnormal tissue that grows and spreads in the body until it kills).

Detailed description

This is a multicenter (when more than one hospital or medical school team work on a medical research study), randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the treatment that the participant receives) study of intetumumab in combination with docetaxel and prednisone for the first-line treatment of participants with metastatic hormone-refractory prostate cancer. There will be 2 study groups. One group will receive intetumumab in combination with docetaxel and prednisone (study treatment) and the other group will receive placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial) matching to intetumumab in combination with docetaxel and prednisone (control treatment). The duration of treatment will be 6 months. Participants who respond to treatment with stable disease or better will receive extended treatment until disease progression (disease worsening) or for an additional 6 months, whichever occurs first. Treatment can be further continued with the sponsor's discretion after receiving 6 months of extended treatment, if participant response to the treatment (with stable disease, partial response, or complete response). Participants who have confirmed progressive disease while receiving study treatment may have their treatment unblinded (participants will know the name of drug which was given to them), if they wish to be considered for alternative treatment. Participants who were receiving the control treatment will be considered to have completed the study treatment, and will have the option to receive alternative treatment. Alternative treatment will either be intetumumab along with docetaxel and prednisone or intetumumab alone. Participants' safety will be monitored throughout the study.

Conditions

• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks.
DRUG	Prednisone	Prednisone 5 mg orally twice daily.
BIOLOGICAL	Intetumumab	Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
DRUG	Placebo	Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-10-01
• Last updated: 2013-06-20
• Results posted: 2013-05-20

Locations

59 sites across 10 countries: United States, Austria, Belgium, Germany, India, Netherlands, Poland, Russia, South Africa, United Kingdom