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

Sponsor
Astellas Pharma Inc (Industry)
Overall Status
Terminated
CT.gov ID
NCT00048659
Collaborator
Astellas Pharma US, Inc. (Industry)
53

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
Actual Study Completion Date :
Jun 1, 2004

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alaska Clinical Research Center, LLC Anchorage Alaska United States
    2 San Bernardino Urological Associates San Bernardino California United States
    3 Western Clinical Research, Inc. Torrance California United States
    4 Shands Hospital Gainesville Florida United States
    5 Sylvester Comprehensive Cancer Center Miami Florida United States
    6 Georgia Urology,PA Research Institute Atlanta Georgia United States
    7 University of Chicago, Section of Hematology/Oncology Chicago Illinois United States
    8 University of Illinois, Department of Urology Chicago Illinois United States
    9 Michiana Hematology/Oncology South Bend Indiana United States
    10 The Urologic Institute of New Orleans Gretna Louisiana United States
    11 Henry Ford Hospital Detroit Michigan United States
    12 Washington University School of Medicine St. Louis Missouri United States
    13 Memphis Cancer Center Memphis Tennessee United States
    14 Virginia Mason Medical Center Seattle Washington United States
    15 Department of Medical Oncology, The Canberra Hospital Canberra Australia
    16 Department of Medical Oncology, Concord Hospital Medical Centre Concord Australia
    17 Division of Oncology Ward, Royal Brisbane Hospital Herston Australia
    18 Department of Clinical Oncology, Royal North Shore Hospital St Leonards Australia
    19 Cancer Care Centre, St. George Hospital Sydney Australia
    20 Department of Medical Oncology, Newcastle Mater Hospital Waratah Australia
    21 Southern Medical Day Care Centre Wollongong Australia
    22 Queen Elizabeth Hospital, Clinical Hematology & Oncology Woodville Australia
    23 Cliniques Universitaires St-Luc, Service d'Urologie Bruxelles Belgium
    24 Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie Charleroi Belgium
    25 Centre Paul Papin Angers France
    26 Service d'Urologie, Hôpital Henri Mondor Creteil France
    27 Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot Lyon France
    28 Service d' Urologie CHU, Hopital Bichat Paris France
    29 Krankenhause am Urban, Urologie Dieffenfachstr Berlin Germany
    30 Dept Urology University of Essen Essen Germany
    31 Urologische Klinik der MHH Hannover Germany
    32 Klinikum Mannheim Urology Mannheim Germany
    33 Mater Misericordiae Hospital Dublin Ireland
    34 Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie Utrecht Netherlands
    35 Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie Krakow Poland
    36 Oddzial Chemioterapii Krakow Poland
    37 Klinika Chemioterapii AM Lodz Poland
    38 Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii Opole Poland
    39 Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow Tarnow Poland
    40 Szpital CSK WAMl, Klinika Okologii Warsaw Poland
    41 Klinika Nowotworow Ukladu Warszawa Poland
    42 Hospital Clinic i Provincial, Servicio de Oncologia Barcelona Spain
    43 Hospital General Vall d'Hebron, Servicio de Oncología Barcelona Spain
    44 Hospital Universitario de Getafe, Servicio de Urologia, Crta Getafe (Madrid) Spain
    45 Hospital Universitario Príncipe de Asturias, Servicio de Urología Madrid Spain
    46 Instituto Valenciano de Oncologia, Servicio de Oncologia Valencia Spain
    47 Department of Urological Research, Derriford Hospital Devon United Kingdom
    48 Clinical Research Centre, St George's Hospital, Urology Division London United Kingdom
    49 Department of Urology, St Bartholomew's Hospital London United Kingdom
    50 Imperial College School of Medicine, Dept Cancer Medicine London United Kingdom
    51 Department of Urology, East Surrey Hospital Surrey United Kingdom
    52 Royal Surrey County Hospital Surrey United Kingdom
    53 St Richard's Hospital West Sussex United Kingdom

    Sponsors and Collaborators

    • Astellas Pharma Inc
    • Astellas Pharma US, Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00048659
    Other Study ID Numbers:
    • 598-CL-008
    First Posted:
    Nov 6, 2002
    Last Update Posted:
    Jun 7, 2012
    Last Verified:
    Jun 1, 2012

    Study Results

    No Results Posted as of Jun 7, 2012