Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
NCT ID: NCT01429064
Last Updated: 2017-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
76 participants
INTERVENTIONAL
2011-06-30
2015-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ODM-201
ODM-201
ODM-201 administered orally daily
Interventions
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ODM-201
ODM-201 administered orally daily
Eligibility Criteria
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Inclusion Criteria
* Successful completion of study protocol 3104001
* Response or stable disease in study 3104001 at week 12
Exclusion Criteria
* Not able to swallow the study drug
18 Years
MALE
No
Sponsors
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Orion Corporation, Orion Pharma
INDUSTRY
Responsible Party
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Principal Investigators
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Karim Fizazi
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Locations
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The Urology Center of Colorado
Wheat Ridge, Colorado, United States
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States
Cleveland Clinic
Cleveland, Ohio, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Klinika onkologie a radioterapie LFUK a FN
Hradec Králové, , Czechia
East-Tallinn Central Hospital
Tallinn, , Estonia
Helsinki University Central Hospital
Helsinki, , Finland
Kuopio University Hospital
Kuopio, , Finland
Oulu University Hospital
Oulu, , Finland
Tampere University Hospital
Tampere, , Finland
Turku University Hospital
Turku, , Finland
Saint Louis Hospital
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Queen Elizabeth Hospital
Birmingham, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Christie Hospital
Manchester, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Countries
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References
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Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.
Fizazi K, Massard C, Bono P, Kataja V, James N, Tammela TL, Joensuu H, Aspegren J, Mustonen M. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naive Prostate Cancer: Results from Extended Follow-up of the ARADES Trial. Eur Urol Focus. 2017 Dec;3(6):606-614. doi: 10.1016/j.euf.2017.01.010. Epub 2017 Feb 27.
Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.
Other Identifiers
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3104002
Identifier Type: -
Identifier Source: org_study_id
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