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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00048659
Other study ID # 598-CL-008
Secondary ID
Status Terminated
Phase Phase 2
First received November 4, 2002
Last updated June 6, 2012
Est. completion date June 2004

Study information

Verified date June 2012
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 0
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
YM598


Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma US, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  France,  Germany,  Ireland,  Netherlands,  Poland,  Spain,  United Kingdom, 

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