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



Status:Recruiting
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:2/4/2013
Start Date:March 2011
Contact:V Mononen
Phone:+358 10 4261

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Safety and Pharmacokinetics of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Multiple Dose Escalation Study With a Randomised Phase II Expansion Component


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


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
6
sites
823 82nd Parkway, Suite B
Myrtle Beach, South Carolina 29572
(843) 449-1010 ext.268
Carolina Urologic Research Center Carolina Urologic Research Center (CURC) has been recognized both nationally and...
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Myrtle Beach, SC
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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2777 Mile High Stadium Circle
Denver, Colorado 80204
303-783-2773
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Denver, CO
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Mt. Laurel, New Jersey 08054
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Mt. Laurel, NJ
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Norwich, CT
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Virginia Beach, Virginia 23462
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Virginia Beach, VA
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