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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00048659




Registration number
NCT00048659
Ethics application status
Date submitted
4/11/2002
Date registered
6/11/2002
Date last updated
7/06/2012

Titles & IDs
Public title
YM598 Added to Mitoxantrone/Prednisone to Control Pain in Metastatic Prostate Cancer Patients No Longer Responding to Hormone Therapy
Scientific title
Secondary ID [1] 0 0
598-CL-008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hormone-Refractory Prostate Cancer 0 0
Prostatic Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - YM598

Treatment: Drugs: YM598


Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes

Eligibility
Key inclusion criteria
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Department of Medical Oncology, The Canberra Hospital - Canberra
Recruitment hospital [2] 0 0
Department of Medical Oncology, Concord Hospital Medical Centre - Concord
Recruitment hospital [3] 0 0
Division of Oncology Ward, Royal Brisbane Hospital - Herston
Recruitment hospital [4] 0 0
Department of Clinical Oncology, Royal North Shore Hospital - St Leonards
Recruitment hospital [5] 0 0
Cancer Care Centre, St. George Hospital - Sydney
Recruitment hospital [6] 0 0
Department of Medical Oncology, Newcastle Mater Hospital - Waratah
Recruitment hospital [7] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [8] 0 0
Queen Elizabeth Hospital, Clinical Hematology & Oncology - Woodville
Recruitment postcode(s) [1] 0 0
- Canberra
Recruitment postcode(s) [2] 0 0
- Concord
Recruitment postcode(s) [3] 0 0
- Herston
Recruitment postcode(s) [4] 0 0
- St Leonards
Recruitment postcode(s) [5] 0 0
- Sydney
Recruitment postcode(s) [6] 0 0
- Waratah
Recruitment postcode(s) [7] 0 0
- Wollongong
Recruitment postcode(s) [8] 0 0
- Woodville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alaska
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Louisiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Washington
Country [12] 0 0
Belgium
State/province [12] 0 0
Bruxelles
Country [13] 0 0
Belgium
State/province [13] 0 0
Charleroi
Country [14] 0 0
France
State/province [14] 0 0
Angers
Country [15] 0 0
France
State/province [15] 0 0
Creteil
Country [16] 0 0
France
State/province [16] 0 0
Lyon
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
Germany
State/province [18] 0 0
Berlin
Country [19] 0 0
Germany
State/province [19] 0 0
Essen
Country [20] 0 0
Germany
State/province [20] 0 0
Hannover
Country [21] 0 0
Germany
State/province [21] 0 0
Mannheim
Country [22] 0 0
Ireland
State/province [22] 0 0
Dublin
Country [23] 0 0
Netherlands
State/province [23] 0 0
Utrecht
Country [24] 0 0
Poland
State/province [24] 0 0
Krakow
Country [25] 0 0
Poland
State/province [25] 0 0
Lodz
Country [26] 0 0
Poland
State/province [26] 0 0
Opole
Country [27] 0 0
Poland
State/province [27] 0 0
Tarnow
Country [28] 0 0
Poland
State/province [28] 0 0
Warsaw
Country [29] 0 0
Poland
State/province [29] 0 0
Warszawa
Country [30] 0 0
Spain
State/province [30] 0 0
Barcelona
Country [31] 0 0
Spain
State/province [31] 0 0
Getafe (Madrid)
Country [32] 0 0
Spain
State/province [32] 0 0
Madrid
Country [33] 0 0
Spain
State/province [33] 0 0
Valencia
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Devon
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Surrey
Country [37] 0 0
United Kingdom
State/province [37] 0 0
West Sussex

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Astellas Pharma Inc
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Astellas Pharma US, Inc.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00048659
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00048659