NCT01429064

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
Completed

Started Jun 2011

Typical duration for phase_2 prostate-cancer

Geographic Reach
6 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

December 22, 2016

Completed
Last Updated

February 20, 2017

Status Verified

January 1, 2017

Enrollment Period

4.4 years

First QC Date

September 1, 2011

Results QC Date

October 28, 2016

Last Update Submit

January 3, 2017

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events

    Adverse events from start of ODM-201 treatment (in ARADES 3104001 study) until end of study visit (in ARADES-EXT 3104002 study). Median duration on study treatment was 11,0 months.

    From first dose of study treatment up to 4 weeks after last dose of study treatment

Study Arms (1)

ODM-201

EXPERIMENTAL
Drug: ODM-201

Interventions

ODM-201DRUG

ODM-201 administered orally daily

ODM-201

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent
  • Successful completion of study protocol 3104001
  • Response or stable disease in study 3104001 at week 12

You may not qualify if:

  • New serious concurrent medical condition
  • Not able to swallow the study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

The Urology Center of Colorado

Wheat Ridge, Colorado, 80211, United States

Location

Eastern CT Hematology and Oncology Associates

Norwich, Connecticut, 06360, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Klinika onkologie a radioterapie LFUK a FN

Hradec Králové, Czechia

Location

East-Tallinn Central Hospital

Tallinn, Estonia

Location

Helsinki University Central Hospital

Helsinki, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Tampere University Hospital

Tampere, Finland

Location

Turku University Hospital

Turku, Finland

Location

Saint Louis Hospital

Paris, France

Location

Institut Gustave Roussy

Villejuif, France

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

Velindre Cancer Centre

Cardiff, United Kingdom

Location

Christie Hospital

Manchester, United Kingdom

Location

Churchill Hospital

Oxford, United Kingdom

Location

Related Publications (3)

  • 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.

    PMID: 28753851DERIVED

  • 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.

    PMID: 28753849DERIVED

  • 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.

    PMID: 24974051DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

darolutamide

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Head of Oncology
Organization
Orion Pharma, Development, R&D
mika.mustonen@orionpharma.com
+358 10 4261

Study Officials

  • Karim Fizazi

    Gustave Roussy, Cancer Campus, Grand Paris

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 5, 2011

Study Start

June 1, 2011

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 20, 2017

Results First Posted

December 22, 2016

Record last verified: 2017-01

Locations

GB(4)CZ(1)ES(1)FR(2)US(4)FI(5)