Study Comparing Orteronel Plus Prednisone in Participants With Chemotherapy-Naive Metastatic Castration-Resistant Prostate Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,560

Participants

Timeline

Start Date

October 1, 2010

Primary Completion Date

January 1, 2014

Study Completion Date

April 7, 2016

Conditions
Prostate Cancer
Interventions
DRUG

Orteronel

Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.

DRUG

Placebo

Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of \<50 ng/dL.

DRUG

Prednisone

Prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of \<50 ng/dL.

Trial Locations (240)

Unknown

Anchorage

Tucson

Duarte

Highland

Orange

Sacramento

San Francisco

Aurora

Denver

Deerfield Beach

Fort Myers

Jacksonville

Orlando

Port Saint Lucie

Jeffersonville

Kansas City

New Orleans

Baltimore

Boston

Lansing

Duluth

Corinth

Columbia

Jefferson City

Omaha

Las Vegas

Hackensack

East Syracuse

New York

Durham

Raleigh

Kettering

Tualatin

Hershey

Lancaster

Philadelphia

Piitsburgh

Charleston

Columbia

Chattanooga

Nashville

Amarillo

Bedford

Dallas

Denton

Tyler

Salt Lake City

Norfolk

Garran

Hobart

Kurralta Park

Nedlands

Perth

Redcliffe

Wodonga

Graz

Linz

Vienna

Minsk

Edegem

Hasselt

Kortrijk

Leuven

Namur

Bairro Nazare - Salvador

Barretos/sp

Belo Horizonte

Campinas

Caxias do Sul

Curitiba

Fortaleza/ce

Ijuí

Joinville

Lajeado - Rs

Piracicaba - Sp

Porto Alegre- Rs

Porto Alegre/rs

Ribeirao Preto - Sp

Rio de Janeiro

Rio de Janeiro Rj

Santo André

São José do Rio Preto

São José dos Campos

São Paulo

Sorocaba - Sp

Plovdiv

Sofia

Varna

Kelowna

Burlington

Hamilton

London

Owen Sound

Toronto

Montreal

Pointe-Claire

Québec

Sherbrooke

Las Condes

Santiago

Temuco

Valparaíso

Santiago de Cali

Hradec Králové

Prague

Joensuu

Oulu

Seinäjoki

Tampere

Angers

Bordeaux

Caen

Créteil

La Roche-sur-Yon

Lyon

Marseille

Nancy

Nantes

Paris

Poitiers

Saint-Etienne

Villejuif

Braunschweig

Dresden

Hamburg

Hanover

Kassel

Kempen

Nürtingen

Tübingen

Wuppertal

Athens

Heraklion Crete

Larissa

Pátrai

Thessaloniki

Kowloon

Shatin

Dublin

Galway

Haifa

Holon

Jerusalem

Petah Tikva

Ramat Gan

Tel Aviv

Ẕerifin

Aviano

Novara

Roma

Torino

Chiba

Fukuoka

Hamamatsu

Hokkaido

Kanazawa

Kita-gun

Maebashi

Mito

Osaka

Sakura

Sayama

Sendai

Shimizucho Sunto-gun

Suntou-gun

Tokyo

Yamagata

Yokohama

Yufu

Riga

Kaunas

Klaipėda

Vilnius

Durango Durango

Mexico City Distrito Federal

Zapopan Jalisco

Amsterdam

Arnhem

Breda

Eindhoven

Heerlen

Nieuwegein

Nijmegen

Rotterdam

Auckland

Christchurch

Dunedin

Takapuna

Tauranga

Lima

Bielsko-Biala

Wroclaw

Liepaja

Lisbon

Porto

San Juan

Bucharest

Cluj-Napoca

Moscow

Saint Petersburg

Singapore

Nitra

Prešov

Trenčín

Žilina

Cape Town

Durban

George

Port Elizabeth

A Coruña

Barcelona

Madrid

Majadahonda

Pamplona

Seville

Valencia

Gothenburg

Stockholm

Uppsala

Aarau

Lausanne

Winterthur

Zurich

Taichung

Taipei

Dnipropetrovsk

Donetsk

Kyiv

Zaporizhzhya

Aberdeen

Belfast

Bristol

Cottingham

Coventry

Glasgow

London

Manchester

Northwood

Preston

Southampton

All Listed Sponsors
lead

Millennium Pharmaceuticals, Inc.

INDUSTRY