Clinical trial NCT01429064: Safety and Tolerability of ODM-201 in Castrate Resistant Prostate Cancer; Extension Study to Study 3104001
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2011-09-05
Enrollment: 76
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: From first dose of study treatment up to 4 weeks after last dose of study treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Wheat Ridge
country: United States
facility: The Urology Center of Colorado
state: Colorado
city: Norwich
country: United States
facility: Eastern CT Hematology and Oncology Associates
state: Connecticut
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Hradec Králové
country: Czech Republic
facility: Klinika onkologie a radioterapie LFUK a FN
city: Tallinn
country: Estonia
facility: East-Tallinn Central Hospital
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital
city: Kuopio
country: Finland
facility: Kuopio University Hospital
city: Oulu
country: Finland
facility: Oulu University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Turku
country: Finland
facility: Turku University Hospital
city: Paris
country: France
facility: Saint Louis Hospital
city: Villejuif
country: France
facility: Institut Gustave Roussy
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Cardiff
country: United Kingdom
facility: Velindre Cancer Centre
city: Manchester
country: United Kingdom
facility: Christie Hospital
city: Oxford
country: United Kingdom
facility: Churchill Hospital
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Karim Fizazi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shore ND, Tammela TL, Massard C, Bono P, Aspegren J, Mustonen M, Fizazi K. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Chemotherapy-naive and CYP17 Inhibitor-naive Patients: Follow-up from the ARADES and ARAFOR Trials. Eur Urol Focus. 2018 Jul;4(4):547-553. doi: 10.1016/j.euf.2017.01.015. Epub 2017 Feb 14.
citation: Fizazi K, Massard C, Bono P, Kataja V, James N, Tammela TL, Joensuu H, Aspegren J, Mustonen M. Safety and Antitumour Activity of ODM-201 (BAY-1841788) in Castration-resistant, CYP17 Inhibitor-naive Prostate Cancer: Results from Extended Follow-up of the ARADES Trial. Eur Urol Focus. 2017 Dec;3(6):606-614. doi: 10.1016/j.euf.2017.01.010. Epub 2017 Feb 27.
citation: Fizazi K, Massard C, Bono P, Jones R, Kataja V, James N, Garcia JA, Protheroe A, Tammela TL, Elliott T, Mattila L, Aspegren J, Vuorela A, Langmuir P, Mustonen M; ARADES study group. Activity and safety of ODM-201 in patients with progressive metastatic castration-resistant prostate cancer (ARADES): an open-label phase 1 dose-escalation and randomised phase 2 dose expansion trial. Lancet Oncol. 2014 Aug;15(9):975-85. doi: 10.1016/S1470-2045(14)70240-2. Epub 2014 Jun 25.