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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01317641
Other study ID # 3104001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received March 7, 2011
Last updated October 20, 2014
Start date March 2011
Est. completion date July 2013

Study information

Verified date October 2014
Source Orion Corporation, Orion Pharma
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteeFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Institutional Ethical CommitteeFinland: Finnish Medicines AgencyFinland: Ethics CommitteeCzech Republic: State Institute for Drug ControlCzech Republic: Ethics CommitteeUnited States: Institutional Review BoardUnited States: Food and Drug AdministrationEstonia: Research Ethics CommitteeEstonia: The State Agency of Medicine
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
ODM-201
ODM-201 administered orally daily

Locations

Country Name City State
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
Estonia East-Tallinn Central Hospital Talinn
Finland 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
France Saint Louis Hospital Paris
France Institut Gustave Roussy Villejuif
United Kingdom Queen Elizabeth Hospital Birmingham
United Kingdom Velindre Cancer Centre Cardiff
United Kingdom Christie Hospital Manchester
United Kingdom Churchill Hospital Oxford
United States Chesapeake Urology Research Associates Baltimore Maryland
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 Eastern CT Hematology and Oncology Associates Norwich Connecticut
United States Urology Health Team PLLC Ocala Florida
United States Delaware Valley urology, LLC Voorhees New Jersey
United States The Urology Center of Colorado Wheat Ridge Colorado

Sponsors (2)

Lead Sponsor Collaborator
Orion Corporation, Orion Pharma Endo Pharmaceuticals

Countries where clinical trial is conducted

United States,  Czech Republic,  Estonia,  Finland,  France,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety and tolerability assessed by incidence of adverse events, vital signs, 12-lead ECG, laboratory assessments and physical examination 3 months Yes
Secondary Pharmacokinetics of ODM-201 and its major metabolite 28 days No
Secondary Response in prostate specific antigen (PSA) and in soft and bone tissues 3 months No
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