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

NCT ID: NCT00048659

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Completion Date

2004-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hormone-Refractory Prostate Cancer Prostatic Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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YM598

Intervention Type DRUG

Eligibility Criteria

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Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Locations

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Alaska Clinical Research Center, LLC

Anchorage, Alaska, United States

Site Status

San Bernardino Urological Associates

San Bernardino, California, United States

Site Status

Western Clinical Research, Inc.

Torrance, California, United States

Site Status

Shands Hospital

Gainesville, Florida, United States

Site Status

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Site Status

Georgia Urology,PA Research Institute

Atlanta, Georgia, United States

Site Status

University of Chicago, Section of Hematology/Oncology

Chicago, Illinois, United States

Site Status

University of Illinois, Department of Urology

Chicago, Illinois, United States

Site Status

Michiana Hematology/Oncology

South Bend, Indiana, United States

Site Status

The Urologic Institute of New Orleans

Gretna, Louisiana, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Memphis Cancer Center

Memphis, Tennessee, United States

Site Status

Virginia Mason Medical Center

Seattle, Washington, United States

Site Status

Department of Medical Oncology, The Canberra Hospital

Canberra, , Australia

Site Status

Department of Medical Oncology, Concord Hospital Medical Centre

Concord, , Australia

Site Status

Division of Oncology Ward, Royal Brisbane Hospital

Herston, , Australia

Site Status

Department of Clinical Oncology, Royal North Shore Hospital

St Leonards, , Australia

Site Status

Cancer Care Centre, St. George Hospital

Sydney, , Australia

Site Status

Department of Medical Oncology, Newcastle Mater Hospital

Waratah, , Australia

Site Status

Southern Medical Day Care Centre

Wollongong, , Australia

Site Status

Queen Elizabeth Hospital, Clinical Hematology & Oncology

Woodville, , Australia

Site Status

Cliniques Universitaires St-Luc, Service d'Urologie

Brussels, , Belgium

Site Status

Centre Hospitalier Notre Dame et Reine Fabiola, Service d'oncologie

Charleroi, , Belgium

Site Status

Centre Paul Papin

Angers, , France

Site Status

Service d'Urologie, Hôpital Henri Mondor

Créteil, , France

Site Status

Pavillon V, Service d'Urologie et de transplatation, Hôpital Edouard Herriot

Lyon, , France

Site Status

Service d' Urologie CHU, Hopital Bichat

Paris, , France

Site Status

Krankenhause am Urban, Urologie Dieffenfachstr

Berlin, , Germany

Site Status

Dept Urology University of Essen

Essen, , Germany

Site Status

Urologische Klinik der MHH

Hanover, , Germany

Site Status

Klinikum Mannheim Urology

Mannheim, , Germany

Site Status

Mater Misericordiae Hospital

Dublin, , Ireland

Site Status

Universitair Medisch Centrum Utrecht, Dienst Medische Oncologie

Utrecht, , Netherlands

Site Status

Kilinika Chemioterapii, Centrum Onkologii Instytut im M sklodowskiej Curie

Krakow, , Poland

Site Status

Oddzial Chemioterapii

Krakow, , Poland

Site Status

Klinika Chemioterapii AM

Lodz, , Poland

Site Status

Samodzielny Publiczny Zaklad Opieki zdrowotnej, Wojewodzki Osrodek Onkologii

Opole, , Poland

Site Status

Szpital Wojewodzki im Sw Lukasza SP ZOZ Tarnow

Tarnów, , Poland

Site Status

Klinika Nowotworow Ukladu

Warsaw, , Poland

Site Status

Szpital CSK WAMl, Klinika Okologii

Warsaw, , Poland

Site Status

Hospital Clinic i Provincial, Servicio de Oncologia

Barcelona, , Spain

Site Status

Hospital General Vall d'Hebron, Servicio de Oncología

Barcelona, , Spain

Site Status

Hospital Universitario de Getafe, Servicio de Urologia, Crta

Getafe (Madrid), , Spain

Site Status

Hospital Universitario Príncipe de Asturias, Servicio de Urología

Madrid, , Spain

Site Status

Instituto Valenciano de Oncologia, Servicio de Oncologia

Valencia, , Spain

Site Status

Department of Urological Research, Derriford Hospital

Devon, , United Kingdom

Site Status

Clinical Research Centre, St George's Hospital, Urology Division

London, , United Kingdom

Site Status

Department of Urology, St Bartholomew's Hospital

London, , United Kingdom

Site Status

Imperial College School of Medicine, Dept Cancer Medicine

London, , United Kingdom

Site Status

Department of Urology, East Surrey Hospital

Surrey, , United Kingdom

Site Status

Royal Surrey County Hospital

Surrey, , United Kingdom

Site Status

St Richard's Hospital

West Sussex, , United Kingdom

Site Status

Countries

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

Other Identifiers

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598-CL-008

Identifier Type: -

Identifier Source: org_study_id

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