CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 131 enrolled
Drug / intervention
Docetaxel +3 moredrug
Likely dose
Docetaxel 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00537381
NCT00537381Phase 2Completed

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

Centocor, Inc.·interventional·Posted Oct 1, 2007·Updated Jun 20, 2013

In Brief

A Phase 2 clinical trial evaluating Docetaxel, Prednisone, and 2 other interventions for Prostatic Neoplasms. Completed, enrolled 131 participants across 59 sites in 10 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Germany, India, Netherlands, Poland, Russia, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2007
Enrollment StartMay 1, 2007
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 18.8 years ago

Interventions

Docetaxeldrug

Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks.

Prednisonedrug

Prednisone 5 mg orally twice daily.

Intetumumabbiological

Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.

Placebodrug

Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.