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

This study has been completed.
Endo Pharmaceuticals
Information provided by (Responsible Party):
Orion Corporation, Orion Pharma Identifier:
First received: March 7, 2011
Last updated: October 20, 2014
Last verified: October 2014
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Condition Intervention Phase
Prostate Cancer
Drug: ODM-201
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Orion Corporation, Orion Pharma:

Primary Outcome Measures:
  • Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Pharmacokinetics of ODM-201 and its major metabolite [ Time Frame: 28 days ]
  • Response in prostate specific antigen (PSA) and in soft and bone tissues [ Time Frame: 3 months ]

Enrollment: 136
Study Start Date: March 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ODM-201 Phase I Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 1 Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 2 Drug: ODM-201
ODM-201 administered orally daily
Experimental: ODM-201 Phase II Dose 3 Drug: ODM-201
ODM-201 administered orally daily


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01317641

United States, Colorado
The Urology Center of Colorado
Wheat Ridge, Colorado, United States, 80211
United States, Connecticut
Eastern CT Hematology and Oncology Associates
Norwich, Connecticut, United States, 06360
United States, Florida
Urology Health Team PLLC
Ocala, Florida, United States, 34474
United States, Maryland
Chesapeake Urology Research Associates
Baltimore, Maryland, United States, 21327
United States, New Jersey
Delaware Valley urology, LLC
Voorhees, New Jersey, United States, 08043
United States, New York
Brooklyn Urology Research Group
Brooklyn, New York, United States, 11215
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
Czech Republic
Klinika onkologie a radioterapie LFUK a FN
Hradec Králové, Czech Republic
Fakultni Nemonicnice Olomouc
Olomouc, Czech Republic
Oddeleni Radiacni a Klinicke Onkologie Nemocnice Znojmo
Znojmo, Czech Republic
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
United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Christie Hospital
Manchester, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Sponsors and Collaborators
Orion Corporation, Orion Pharma
Endo Pharmaceuticals
Principal Investigator: Karim Fizazi Gustave Roussy, Cancer Campus, Grand Paris
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Orion Corporation, Orion Pharma Identifier: NCT01317641     History of Changes
Other Study ID Numbers: 3104001
Study First Received: March 7, 2011
Last Updated: October 20, 2014

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on March 24, 2017