Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer
NCT ID: NCT01317641
Last Updated: 2017-03-29
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
136 participants
INTERVENTIONAL
2011-03-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ODM-201 Phase I
ODM-201
ODM-201 administered orally daily
ODM-201 Phase II Dose 1
ODM-201
ODM-201 administered orally daily
ODM-201 Phase II Dose 2
ODM-201
ODM-201 administered orally daily
ODM-201 Phase II Dose 3
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
* Histologically confirmed adenocarcinoma of prostate
* Ongoing androgen deprivation therapy with a LHRH analogue or antagonist or bilateral orchiectomy
* Progressive metastatic disease
* Adequate bone marrow, hepatic, and renal function
Exclusion Criteria
* History of other malignancy within the previous 5 years
* Known gastrointestinal disease or procedure that affects the absorption
* Not able to swallow the study drug
18 Years
MALE
No
Sponsors
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Endo Pharmaceuticals
INDUSTRY
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
Urology Health Team PLLC
Ocala, Florida, United States
Chesapeake Urology Research Associates
Baltimore, Maryland, United States
Delaware Valley urology, LLC
Voorhees Township, New Jersey, United States
Brooklyn Urology Research Group
Brooklyn, New York, 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
Fakultni Nemonicnice Olomouc
Olomouc, , Czechia
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
Znojmo, , Czechia
East-Tallinn Central Hospital
Talinn, , 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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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.
Related Links
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Lancet Oncology publication containing study results
PubMed link to the Lancet Oncology publication containing study results
Other Identifiers
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3104001
Identifier Type: -
Identifier Source: org_study_id
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