YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy

June 6, 2012 updated by: Astellas Pharma Inc
The purpose of this study is to determine if patients who take YM598 in addition to mitoxantrone and prednisone (standard therapy) experience improvement in the pain associated with prostate cancer metastases in the bone.

Study Overview

Status

Status

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

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.

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

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

  • Australia
      • Canberra, Australia
        • Department of Medical Oncology, The Canberra Hospital
      • Concord, Australia
        • Department of Medical Oncology, Concord Hospital Medical Centre
      • Herston, Australia
        • Division of Oncology Ward, Royal Brisbane Hospital
      • St Leonards, Australia
        • Department of Clinical Oncology, Royal North Shore Hospital
      • Sydney, Australia
        • Cancer Care Centre, St. George Hospital
      • Waratah, Australia
        • Department of Medical Oncology, Newcastle Mater Hospital
      • Wollongong, Australia
        • Southern Medical Day Care Centre
      • Woodville, Australia
        • Queen Elizabeth Hospital, Clinical Hematology & Oncology
  • Belgium
      • Bruxelles, Belgium
        • Cliniques Universitaires St-Luc, Service d'Urologie
      • Charleroi, Belgium
        • Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie
  • France
      • Angers, France
        • Centre Paul Papin
      • Creteil, France
        • Service d'Urologie, Hôpital Henri Mondor
      • Lyon, France
        • Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot
      • Paris, France
        • Service d' Urologie CHU, Hopital Bichat
  • Germany
      • Berlin, Germany
        • Krankenhause am Urban, Urologie Dieffenfachstr
      • Essen, Germany
        • Dept Urology University of Essen
      • Hannover, Germany
        • Urologische Klinik der MHH
      • Mannheim, Germany
        • Klinikum Mannheim Urology
  • Ireland
      • Dublin, Ireland
        • Mater Misericordiae Hospital
  • Netherlands
      • Utrecht, Netherlands
        • Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie
  • Poland
      • Krakow, Poland
        • Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie
      • Krakow, Poland
        • Oddzial Chemioterapii
      • Lodz, Poland
        • Klinika Chemioterapii AM
      • Opole, Poland
        • Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii
      • Tarnow, Poland
        • Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow
      • Warsaw, Poland
        • Szpital CSK WAMl, Klinika Okologii
      • Warszawa, Poland
        • Klinika Nowotworow Ukladu
  • Spain
      • Barcelona, Spain
        • Hospital Clinic i Provincial, Servicio de Oncologia
      • Barcelona, Spain
        • Hospital General Vall d'Hebron, Servicio de Oncología
      • Getafe (Madrid), Spain
        • Hospital Universitario de Getafe, Servicio de Urologia, Crta
      • Madrid, Spain
        • Hospital Universitario Príncipe de Asturias, Servicio de Urología
      • Valencia, Spain
        • Instituto Valenciano de Oncologia, Servicio de Oncologia
  • United Kingdom
      • Devon, United Kingdom
        • Department of Urological Research, Derriford Hospital
      • London, United Kingdom
        • Clinical Research Centre, St George's Hospital, Urology Division
      • London, United Kingdom
        • Department of Urology, St Bartholomew's Hospital
      • London, United Kingdom
        • Imperial College School of Medicine, Dept Cancer Medicine
      • Surrey, United Kingdom
        • Royal Surrey County Hospital
      • Surrey, United Kingdom
        • Department of Urology, East Surrey Hospital
      • West Sussex, United Kingdom
        • St Richard's Hospital
  • United States
    • Alaska
      • Anchorage, Alaska, United States
        • Alaska Clinical Research Center, LLC
    • California
      • San Bernardino, California, United States
        • San Bernardino Urological Associates
      • Torrance, California, United States
        • Western Clinical Research, Inc.
    • Florida
      • Gainesville, Florida, United States
        • Shands Hospital
      • Miami, Florida, United States
        • Sylvester Comprehensive Cancer Center
    • Georgia
      • Atlanta, Georgia, United States
        • Georgia Urology,PA Research Institute
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago, Section of Hematology/Oncology
      • Chicago, Illinois, United States
        • University of Illinois, Department of Urology
    • Indiana
      • South Bend, Indiana, United States
        • Michiana Hematology/Oncology
    • Louisiana
      • Gretna, Louisiana, United States
        • The Urologic Institute of New Orleans
    • Michigan
      • Detroit, Michigan, United States
        • Henry Ford Hospital
    • Missouri
      • St. Louis, Missouri, United States
        • Washington University School of Medicine
    • Tennessee
      • Memphis, Tennessee, United States
        • Memphis Cancer Center
    • Washington
      • Seattle, Washington, United States
        • Virginia Mason Medical Center

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

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: Double

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.
Astellas Pharma Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Astellas Pharma US, 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 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.
June 1, 2004

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).
November 4, 2002

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.
November 5, 2002

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.
November 6, 2002

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 7, 2012

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 6, 2012

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, 2012

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.
  • 598-CL-008

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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