Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001

Prostate Cancer Clinical Trial

Official title:

Safety and Tolerability of ODM-201 in Patients With Castrate Resistant Prostate Cancer: Open, Non-randomised, Uncontrolled, Multicentre, Extension Study to Study 3104001

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01429064
• Other study ID #: 3104002
• Status: Completed
• Phase: Phase 2
• First received: September 1, 2011
• Last updated: January 11, 2016
• Start date: June 2011
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• 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 Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent

• Successful completion of study protocol 3104001

• Response or stable disease in study 3104001 at week 12

Exclusion Criteria:

• New serious concurrent medical condition

• Not able to swallow the study drug

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

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
Estonia	East-Tallinn Central Hospital	Tallinn
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	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	The Urology Center of Colorado	Wheat Ridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Orion Corporation, Orion Pharma

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		until disease progression, an expected average of 6 months	Yes
Secondary	Response in prostate specific antigen (PSA) and in soft and bone tissues		until disease progression, an expected average of 6 months	No