Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

Completed · Phase 1/Phase 2

Conditions studied: Prostate Cancer

In brief

The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Key facts

Study ID

NCT01317641

Run by

Orion Corporation, Orion Pharma

People needed

136

Starts

2011-03-01

Expected to finish

2013-07-01

Last updated by the study team

2017-03-29

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent
• 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

You may not qualify if…

• Known metastases in the brain
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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