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

NCT00537381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2013-06-20

Study results available
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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).

Conditions

  • Prostatic Neoplasms

Interventions

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.

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States
  • Austria
  • Belgium
  • Germany
  • India
  • Netherlands
  • Poland
  • Russia
  • South Africa
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00537381 on ClinicalTrials.gov