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

June 12, 2013 updated by: Centocor, Inc.

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria
      • Wels N/A, Austria
      • Wien, Austria
  • Belgium
      • Antwerpen, Belgium
      • Brasschaat, Belgium
      • Brussel, Belgium
      • Doornik, Belgium
      • Haine-Saint-Paul, La Louviere, Belgium
      • Leuven, Belgium
      • Liÿge, Belgium
      • Ottignies, Belgium
      • Roeselare, Belgium
      • Wilrijk, Belgium
  • Germany
      • Aschaffenburg, Germany
      • Berlin, Germany
      • Freiburg, Germany
      • Kirchheim, Germany
      • Köln, Germany
      • Marburg, Germany
      • München, Germany
      • Tübingen, Germany
  • India
      • Ahmedabad, India
      • Bangalore, India
      • Chennai, India
      • Mumbai, India
      • New Delhi, India
      • Pune, India
  • Netherlands
      • Apeldoorn, Netherlands
      • Den Haag, Netherlands
      • Leiden, Netherlands
      • Maastricht, Netherlands
      • Nijmegen, Netherlands
  • Poland
      • Bydgoszcz, Poland
      • Gdansk, Poland
      • Inowroclaw, Poland
      • Koscierzyna, Poland
      • Lodz, Poland
      • Lublin, Poland
  • Russian Federation
      • Ekaterinburg, Russian Federation
      • Moscow, Russian Federation
      • Moscow N/A, Russian Federation
      • Moscow Region, Russian Federation
      • St Petersburg, Russian Federation
      • St-Petersburg Leningrad, Russian Federation
      • Voronezh, Russian Federation
      • Yaroslavl, Russian Federation
  • South Africa
      • Johannesburg Gauteng, South Africa
      • Pretoria, South Africa
      • Pretoria Gauteng, South Africa
  • United Kingdom
      • Cambridge, United Kingdom
      • Leicester, United Kingdom
      • Lincoln, United Kingdom
      • London, United Kingdom
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • California
      • Los Angeles, California, United States
      • San Bernardino, California, United States
    • Kansas
      • Wichita, Kansas, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • South Carolina
      • Charleston, South Carolina, United States
      • N Charleston, South Carolina, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria

  • 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
  • Have progressive hormone-refractory disease after orchiectomy or gonadotropin-releasing hormone analog and/or antiandrogen treatment within 6 months prior to the first study agent administration Exclusion Criteria
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Docetaxel + Prednisone + Placebo
Matching 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.
Drug: Docetaxel
Docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks.
Drug: Prednisone
Prednisone 5 mg orally twice daily.
Drug: Placebo
Placebo matching to intetumumab, as intravenous infusion every week for initial 6 weeks, then every 3 weeks.
Experimental: Docetaxel + Prednisone + Intetumumab
Intetumumab 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.
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.
Other Names:
  • CNTO 95

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Best Overall Response (OR)
Time Frame: Baseline up to 6 months after last dose of study treatment, assessed up to 551 days
Number of participants with best OR is based on assessment of confirmed complete response (CR) or confirmed partial response (PR). Confirmed CR is defined as disappearance of all target lesions. Confirmed PR is defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
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
Time Frame: Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
The PSA response is defined as at least a 50 percent decrease in PSA below the baseline value, confirmed by a second PSA value greater than or equal to 6 weeks later. A participant was considered to be a PSA responder if and only if the response occurs prior to PSA progression (increase of at least 25 percent and an increase of 5 nanogram per milliliter from the lowest observed PSA value since initiation of treatment, to be confirmed greater than or equal to 3 weeks later).
Baseline up to 6 months after last dose of study treatment or early withdrawal, assessed up to 601 days
Overall Survival
Time Frame: Baseline until death (up to 887 days)
Overall Survival is defined as the time from the date of randomization to death due to any cause. For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
Baseline until death (up to 887 days)
Percent Change From Baseline in 'C-telopeptide of Type I Collagen (CTx)' Marker Concentration
Time Frame: Baseline, Week 6, 7, 10 and 13
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Baseline, Week 6, 7, 10 and 13
Percent Change From Baseline in 'N-telopeptide of Type I Collagen (NTx)' Marker Concentration
Time Frame: Baseline, Week 6, 7, 10 and 13
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Baseline, Week 6, 7, 10 and 13
Percent Change From Baseline in 'Vascular Endothelial Growth Factor (VEGF)' Marker Concentration
Time Frame: Baseline, Week 6, 7, 10 and 13
Percent change = marker concentration at time of measurement minus baseline value divided by baseline value multiplied by 100.
Baseline, Week 6, 7, 10 and 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centocor, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 27, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 1, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR013249
  • C1034T08 (Other Identifier: Centocor, Inc.)
  • 2006-005766-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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