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
3 other identifiers
interventional
131
10 countries
59
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2007
59 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 27, 2007
CompletedFirst Posted
Study publicly available on registry
October 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
May 20, 2013
CompletedJune 20, 2013
June 1, 2013
2.5 years
September 27, 2007
March 28, 2013
June 12, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS)
The PFS was assessed as median number of days from baseline until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Secondary Outcomes (6)
Number of Participants With Best Overall Response (OR)
Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Number of Participants With Prostate Specific Antigen (PSA) Response
Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
Overall Survival
Baseline until death (up to 887 days)
Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Baseline, Week 6, 7, 10 and 13
Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Baseline, Week 6, 7, 10 and 13
- +1 more secondary outcomes
Study Arms (2)
Docetaxel + Prednisone + Placebo
ACTIVE COMPARATORMatching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m\^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Docetaxel + Prednisone + Intetumumab
EXPERIMENTALIntetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
Interventions
Docetaxel 75 mg/m\^2 as intravenous infusion every 3 weeks.
Prednisone 5 mg orally twice daily.
Intetumumab 10 mg/kg as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
Eligibility Criteria
You may qualify if:
- Confirmed cancer of the prostate
- Evidence of metastatic disease
- Have a life expectancy greater than 12 weeks
- Have at least 4 weeks from previous major surgery to date of first study agent given
You may not qualify if:
- Have known Central Nervous System metastases (cancerous tumors that have spread to the brain from somewhere else in the body)
- Had prior systemic non-hormonal therapy for hormone refractory prostate cancer
- Have known Human Immunodeficiency Virus (HIV, a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) seropositivity or known hepatitis B or C infection
- Have planned major surgery during the study
- Have taken any over-the-counter (medicine that can be bought without a prescription) or herbal treatment for prostate cancer within 4 weeks prior to the first study treatment administration
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centocor, Inc.lead
Study Sites (59)
Unknown Facility
Birmingham, Alabama, United States
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Los Angeles, California, United States
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San Bernardino, California, United States
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Wichita, Kansas, United States
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Shreveport, Louisiana, United States
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Charleston, South Carolina, United States
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North Charleston, South Carolina, United States
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Graz, Austria
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Vienna, Austria
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Wels, Austria
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Antwerp, Belgium
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Brasschaat, Belgium
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Brussels, Belgium
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Haine-Saint-Paul, La Louviere, Belgium
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Leuven, Belgium
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Liÿge, Belgium
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Ottignies, Belgium
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Roeselare, Belgium
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Tournai, Belgium
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Wilrijk, Belgium
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Aschaffenburg, Germany
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Berlin, Germany
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Cologne, Germany
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Freiburg im Breisgau, Germany
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Kirchheim, Germany
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Marburg, Germany
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München, Germany
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Tübingen, Germany
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Ahmedabad, India
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Bangalore, India
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Chennai, India
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Mumbai, India
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New Delhi, India
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Pune, India
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Apeldoorn, Netherlands
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Leiden, Netherlands
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Maastricht, Netherlands
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Nijmegen, Netherlands
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The Hague, Netherlands
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Bydgoszcz, Poland
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Gdansk, Poland
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Inowrocław, Poland
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Kościerzyna, Poland
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Lodz, Poland
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Lublin, Poland
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Moscow, Russia
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Moscow Region, Russia
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Saint Petersburg, Russia
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St-Petersburg Leningrad, Russia
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Voronezh, Russia
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Yaroslavl, Russia
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Yekaterinburg, Russia
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Johannesburg Gauteng, South Africa
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Pretoria, South Africa
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Pretoria Gauteng, South Africa
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Cambridge, United Kingdom
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Leicester, United Kingdom
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Lincoln, United Kingdom
Unknown Facility
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Treatment with intetumumab/placebo was permanently discontinued after a planned, preliminary review of interim analysis data. Therefore, study treatment with intetumumab was not completed for some participants.
Results Point of Contact
- Title
- Senior Director
- Organization
- Janssen Research & Development, L.L.C.
Study Officials
- STUDY DIRECTOR
Centocor, Inc. Clinical Trial
Centocor, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2007
First Posted
October 1, 2007
Study Start
May 1, 2007
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
June 20, 2013
Results First Posted
May 20, 2013
Record last verified: 2013-06