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NCT02960022PHASE2Recruiting

A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Astellas Pharma Global Development, Inc.

Start Date

12/22/2016

Completion Date

7/31/2029

Summary

The purpose of this study is to collect long term safety data in subjects who are continuing to derive clinical benefit from treatment with Enzalutamide from the subjects participation in an enzalutamide clinical study sponsored by Astellas or Medivation (i.e., parent study) which has completed, at a minimum, the primary analysis or the study specified evaluation period.

Detailed Description

Subjects must continue on the treatment regimen that the subject was receiving in the prior study. Dose changes of any of the prior therapies subjects were receiving on the previous protocol are allowed after medical monitor approval. The day 1 visit for this study should coincide with the last treatment visit for the study the subject will be enrolling from (≤ 7 days post last visit of parent study) unless the subject is on treatment suspension. The subjects will be followed according to the local institution's standard of care and will be required to return to the institution every 24 weeks (± 7 days) to review adverse events (AEs), collect concomitant medications and confirm that no discontinuation criteria are met. At each visit and at every 12 weeks (IP only visit) subjects are to return all dispensed study drug and to receive more study drug if applicable. All AEs (new and ongoing from the study the subject is enrolling from) and Serious Adverse Events (SAEs) (including death), will be collected from the time the subject signs the consent form until the end of study visit. After the marketing approval in South Korea, this study continued as "post marketing clinical study" in South Korea. In the rest of the countries which participated in this study, this study continued as clinical study.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Subject must currently be receiving enzalutamide or assigned to receive enzalutamide (if on treatment suspension) for prostate cancer in a study sponsored by Astellas or Medivation and, based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible. * Subject is able to continue on the treatment regimen that they were receiving or were assigned to receive in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dose change in Androgen deprivation therapy (ADT) or dropping of a combination therapy) approval from a medical monitor is required prior to enrollment. * Subject is able to swallow enzalutamide capsules and comply with study requirements. * Subject and female partner who is of childbearing potential must continue to use 2 forms of birth control, of which 1 must be highly effective and 1 must be a barrier method throughout the study and for 3 months after final enzalutamide administration. * Subject agrees to avoid sperm donation during the study and for at least 3 months after final enzalutamide administration. * Subject agrees not to participate in another interventional study while on treatment. Canada Specific: * Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent and privacy language as per national regulations (e.g., Health Insurance Portability and Accountability Act authorization for the United States sites) must be obtained from the subject prior to any study-related procedures. * Subject must currently be receiving enzalutamide for breast cancer in a study sponsored by Astellas or Medivation/Pfizer and based on the investigator's assessment, benefit from continued treatment. Subjects participating in investigator-initiated trials are not eligible. * Subject is able to continue on the treatment regimen that they were receiving in the prior study. If in the investigator's assessment, a change is needed to the subject's regimen (e.g., dropping of a combination therapy) approval from a medical monitor is required prior to enrollment. * Subject is able to swallow enzalutamide capsules and comply with study requirements. * Subject is either: * Of nonchildbearing potential: * postmenopausal (defined as no spontaneous menses for at least 12 months prior to Day 1 with follicle stimulating hormone (FSH) \> 40 IU/L at Day 1 for women \< 55 years of age), * documented surgically sterile or status post hysterectomy (at least 1 month prior to Day 1), * Or, if of childbearing potential, * must have a negative urine pregnancy test at Day 1 before the first dose of study drug is administered, * must use 2 acceptable methods of birth control starting at Day 1 and through 6 months after the final study drug administration, * must not donate ova starting at first administration of study intervention and throughout 6 months after final study intervention administration. The 2 acceptable methods of birth control are as follows or per local guidelines where these require additional description of contraceptive methods: * A barrier method (e.g., condom by a male partner) is required; AND * One of the following is required: * Placement of an intrauterine device (IUD) or intrauterine system (IUS); * Additional barrier method including occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository; * Vasectomy or other surgical castration at least 6 months before Day 1. * The subject must not be breastfeeding at Day 1 or during the study period, and for 6 months after the final study drug administration. * Subject agrees not to participate in another interventional study while on treatment. Exclusion Criteria: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which subject is enrolling from. * Subject requires treatment with or plans to use either of the following: * New systemic therapy for subjects cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment. * Investigational therapy other than enzalutamide. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data. Canada Specific: Subject will be excluded from participation if any of the following apply: * Subject met any of the discontinuation criteria or whose cancer progressed on the current enzalutamide clinical study in which they are enrolling from. * Subject requires treatment with or plans to use any of the following: * New systemic therapy for their cancer (palliative radiation therapy is allowed). The treatment with agents administered during previous studies which was stopped and then restarted during this study does not represent new treatment. * Investigational therapy other than enzalutamide. * Subject is currently participating in an investigator-initiated interventional trial and receiving enzalutamide. * Subject has any concurrent disease, infection, or comorbid condition that interferes with the ability of the subject to participate in the study, which places the subject at undue risk or complicates the interpretation of data in the opinion of the investigator.

Interventions

DRUG

enzalutamide

DRUG

abiraterone acetate

DRUG

prednisone

DRUG

Leuprolide acetate

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Conditions

Prostate Cancer

Locations

Site US10052

Anchorage, Alaska 99503

United States

Site US10011

Tucson, Arizona 85741

United States

Site US10040

Los Angeles, California 90024

United States

Site US10009

Los Angeles, California 90048

United States

Site US10067

Orange, California 92868

United States

Site US10008

San Bernardino, California 92404

United States

Site US10042

San Diego, California 92108

United States

Site US10028

Stanford, California 94305

United States

Site US10001

Aurora, Colorado 80045

United States

Site US10017

Denver, Colorado 80211

United States

Site US10050

Washington D.C., District of Columbia 20037

United States

Site US10049

Daytona Beach, Florida 32114

United States

Site US10048

Jacksonville, Florida 32216

United States

Site US10002

Chicago, Illinois 60637

United States

Springfield Clinic, LLP

Springfield, Illinois 62701

United States

Site US10007

Jeffersonville, Indiana 47130

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Site US10066

Lenexa, Kansas 66214-1656

United States

Site US10029

Towson, Maryland 21204

United States

Site US10032

St Louis, Missouri 63110

United States

Nebraska Medical Hospital

Omaha, Nebraska 68114

United States

Site US10023

Omaha, Nebraska 68130

United States

Site US10004

Hackensack, New Jersey 07601

United States

Site US10024

Garden City, New York 11530

United States

Site US10055

New York, New York 10065

United States

Site US10059

New York, New York 10065

United States

Hudson Valley Urology, PC

Poughkeepsie, New York 12601

United States

Site US10053

Syracuse, New York 13210

United States

Site US10030

Chapel Hill, North Carolina 27599

United States

Site US10062

Charlotte, North Carolina 28207

United States

Site US10020

Concord, North Carolina 28025

United States

Site US10031

Greensboro, North Carolina 27403

United States

Eastern Urological Associates

Greenville, North Carolina 27834

United States

Site US10046

Winston-Salem, North Carolina 27157

United States

Site US10035

Cincinnati, Ohio 45212

United States

Site US10022

Springfield, Oregon 97477

United States

Site US10027

Lancaster, Pennsylvania 17604

United States

Site US10005

Pittsburgh, Pennsylvania 15232

United States

Site US10018

Charleston, South Carolina 29414

United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina 29572

United States

Site US10003

Myrtle Beach, South Carolina 29572

United States

Site US10041

Nashville, Tennessee 37232-2765

United States

Site US10010

Dallas, Texas 75231

United States

Site US10034

Houston, Texas 77024

United States

Site US10043

Houston, Texas 77030

United States

Site US10014

Norfolk, Virginia 23502

United States

Site US10015

Virginia Beach, Virginia 23462

United States

Virginia Mason Medical Center

Seattle, Washington 98101

United States

Site US10038

Seattle, Washington 98109

United States

Site US10021

Madison, Wisconsin 53792

United States

Site AR54005

Buenos Aires, Buenos Aires F.D. C1120AAT

Argentina

Site AR54007

Rosario, Santa Fe Province S2000DSV

Argentina

Site AR54008

Buenos Aires,

Argentina

Site AR54003

Cordorba,

Argentina

Site AR54006

San Miguel de Tucumán, T4000IAK

Argentina

Site AR54002

San Miguel de Tucumán,

Argentina

Site AU61014

Albury, New South Wales 2640

Australia

Site AU61001

Tweed Heads, New South Wales 2485

Australia

Site AU61012

Wahroonga, New South Wales 2076

Australia

Site AU61017

Wahroonga, New South Wales 2076

Australia

Site AU61006

Ashford,

Australia

Site AU61019

Ballarat, 3350

Australia

Site AU61007

East Bentleigh, 3165

Australia

Site AU61009

Malvern,

Australia

Site AU61021

Parkville,

Australia

Site AU61008

South Brisbane,

Australia

Site AU61016

St Albans, 3021

Australia

Site AU61004

Westmead, 2145

Australia

Site AT43001

Vienna, 1090

Austria

Site BE32002

Kortrijk, West-Vlaanderen 8500

Belgium

Site BE32009

Anderlecht, 1070

Belgium

Site BE32004

Brussels, B-1090

Belgium

Site BE32005

Ghent, 9000

Belgium

Site BE32011

Ghent, 9000

Belgium

Site BE32007

Hasselt,

Belgium

Site BE32008

Leuven, 3000

Belgium

Site BE32001

Liège, 4000

Belgium

Site BE32003

Turnhout, 2300

Belgium

Site BR55007

Porto Alegre, Rio Grande do Sul 90430-090

Brazil

Site BR55009

Bahia, 41253-190

Brazil

Site BR55008

Campinas,

Brazil

Site BR55004

Ijuí, 98700-000

Brazil

Site BR55011

Jaú,

Brazil

Site BR55002

Rio Grande, 90610-000

Brazil

Site BR55010

Santo André, 09060-650

Brazil

Site CA15003

Kingston, Ontario K7L 3J7

Canada

Site CA15021

Toronto, Ontario M4N 3M5

Canada

Site CA15001

Granby, Quebec J2G 8Z9

Canada

Site CA15019

Abbotsford British Columbia, V2S 3N5

Canada

Site CA15020

Greenville, L6R 3J7 27834

Canada

Site CA15011

Montreal,

Canada

Site CA15017

Oakville, L6H 3P1

Canada

Site CA15022

Québec, QC / G1S 4L8

Canada

Site CL56007

Santiago, RM 7500787

Chile

Site CL56005

Santiago, RM 75009

Chile

Site CL56006

Viña del Mar, Valparaiso 2520598

Chile

Site CL56004

IX Region,

Chile

Site CL56002

Santiago,

Chile

Site CL56001

Viña del Mar,

Chile

Site CN86003

Hubei, 430030

China

Site CN86010

Hunan, 410013

China

Site CN86005

Nanjing,

China

Site CZ42004

Olomouc, 775 20

Czechia

Site CZ42002

Olomouc, 779 00

Czechia

Site CZ42001

Prague, 16000

Czechia

Site CZ42003

Prague,

Czechia

Site DK45002

Aalborg, North Denmark 9000

Denmark

Site DK45003

Aarhus, 8200

Denmark

Site DK45001

Copenhagen, 2100

Denmark

Site DK45004

Herlev, 2730

Denmark

Site DK45006

Vejle, 7100

Denmark

Site FL35802

Tampere,

Finland

Site FL35805

Turku, 20521

Finland

Site FR33021

Bordeaux, 33076

France

Site FR33008

La Roche-sur-Yon, 85925

France

Site FR33010

Lille, 59037

France

Site FR33002

Lyon, 69003

France

Site FR33020

Montpellier, 34298

France

Site FR33006

Nîmes, 30029

France

Site FR33003

Paris,

France

Site FR33017

Paris,

France

Site FR33001

Saint-Herblain,

France

Site FR33019

Strasbourg, 67000

France

Site FR33022

Strasbourg, 67098

France

Site FR33004

Villejuif,

France

Site GE99501

Tbilisi, GE- 0186

Georgia

Site DE49004

Nürtingen, Baden-Wurttemberg 72622

Germany

Site DE49007

Waldshut-Tiengen, Baden-Wurttemberg 79761

Germany

Site DE49006

Mannheim, DE 68167

Germany

Site DE49001

Duisburg, North Rhine-Westphalia 47179

Germany

Site DE49010

Bonn, 53111

Germany

Site DE49003

Hamburg, 22081

Germany

Site DE49013

Hamburg,

Germany

Site HK85202

Hong Kong,

Hong Kong

Site IL97206

Haifa, 3109601

Israel

Site IL97205

Jerusalem,

Israel

Site IL97202

Peth Tikva,

Israel

Site IL97204

Ramat Gan,

Israel

Site IL97203

Tzrifin Beer Yakov,

Israel

Site IT39008

Faenza (RA), Emilia-Romagna 48018

Italy

Site IT39001

Arezzo,

Italy

Site IT39011

Candiolo,

Italy

Site IT39004

Cremona,

Italy

Site IT39002

Forlì,

Italy

Site IT39005

Roma,

Italy

Site IT39009

Toscana,

Italy

Site IT39006

Trento, 38122

Italy

Toho University Sakura Medical Center

Sakura-shi, Chiba

Japan

Kyushu University Hospital

Higashiku, Fukuoka

Japan

Gunma University Hospital

Maebashi, Gunma

Japan

Kagawa University Hospital

Kida-gun, Kagawa-ken

Japan

Yokohama City University Medical Center

Yokohama, Kanagawa 232-0024

Japan

Kindai University Hospital

Sayama, Osaka 589-8511

Japan

Nippon Medical School Hospital

Bunkyo-ku, Tokyo

Japan

The Cancer Institute Hospital of Japanese Foundation for Cancer Research

Koutou-ku, Tokyo

Japan

Yamaguchi University Hospital

Ube, Yamaguchi

Japan

Chiba cancer center

Chiba, 260-8717

Japan

Harasanshin hospital

Fukuoka, 812-0033

Japan

Kyoto University hospital

Kyoto, 606-8507

Japan

Niigata University Medical and Dental Hospital

Niigata, 951-8520

Japan

Osaka Metropolitan University Hospital

Osaka,

Japan

Site MY60001

Kuching, 93586

Malaysia

Site MD37301

Chisinau,

Moldova

Site NL31010

Amsterdam, 1066 CX

Netherlands

Site NL31009

Den Helder,

Netherlands

Site NL31004

Maastricht, 6229

Netherlands

Site NL31011

Rotterdam, 3045 PM

Netherlands

Site NZ64002

Auckland, V2S 3N5

New Zealand

Site NZ64005

Dunedin, 9016

New Zealand

Site NZ64001

Hamilton,

New Zealand

Site NO47001

Stavanger,

Norway

Site PL48002

Gdansk,

Poland

Site PL48001

Mysłowice,

Poland

Site PL48004

Pozman,

Poland

Site PL48005

Słupsk, 76-200

Poland

Site PL48011

Warsaw, 04-073

Poland

Site PL48003

Wroclaw, 54-144

Poland

Site RO40003

Bucharest, 50659

Romania

Site RO40001

Cluj-Napoca, 400015

Romania

Site RO40004

Cluj-Napoca, 400015

Romania

Site RU70008

Ivanovo, 153040

Russia

Site RU70001

Moscow, 125284

Russia

Site RU70005

Omsk,

Russia

Site RU70009

Saint Petersburg, 191104

Russia

Site RU70003

Saint Petersburg,

Russia

Site RU70006

Saint Petersburg,

Russia

Site RS38102

Belgrade, 11040

Serbia

Site RS38101

Belgrade, 11080

Serbia

Site SK10223

Bratislava,

Slovakia

Site SK42109

Košice, 04001

Slovakia

Site SK42106

Košice, 04191

Slovakia

Site SK42105

Nitra, 949 01

Slovakia

Site SK42103

Prešov, 080 01

Slovakia

Site SK42108

Trenčín, 91101

Slovakia

Site SK42107

Žilina,

Slovakia

Site ZA27001

George, 6529

South Africa

Site KR82008

Busan, 49241

South Korea

Site KR82012

Seongnam-si, 013620

South Korea

Site KR82005

Seongnam-si,

South Korea

Site KR82009

Seoul, 03080

South Korea

Site KR82007

Seoul, 06351

South Korea

Site KR82011

Seoul, 138-736

South Korea

Site KR82001

Seoul,

South Korea

Site KR82002

Seoul,

South Korea

Site KR82003

Seoul,

South Korea

Site KR82004

Seoul,

South Korea

Site ES34007

Barcelona, 08036

Spain

Site ES34003

Barcelona,

Spain

Site ES34004

Barcelona,

Spain

Site ES34011

Girona, 17007

Spain

Site ES34012

Madrid, 28006

Spain

Site ES34001

Madrid, 28034

Spain

Site ES34008

Madrid,

Spain

Site ES34005

Pamplona,

Spain

Site ES34014

Salamanca,

Spain

Site ES34010

Santiago de Compostela, 15706

Spain

Site SE46001

Gothenburg, 41345

Sweden

Site SE46003

Umeå, 90185

Sweden

Site TW88607

Guishan, 33305

Taiwan

Site TW88603

Kaohsiung City, 81362

Taiwan

Site TW88601

Kaohsiung City,

Taiwan

Site TW88602

Taichung, 40447

Taiwan

Site TW88606

Taipei, 10002

Taiwan

Site TH66001

Hat Yai, Changwat Songkhla 90110

Thailand

Site TH66002

Bangkok, 10330

Thailand

Site TR90002

Beşevler, Ankara 06500

Turkey (Türkiye)

Site UA38004

Dnipro, 49005

Ukraine

Site UA38005

Kharkiv, 61037

Ukraine

Site UA38001

Kyiv, 02125

Ukraine

Site UA38003

Uzhhorod, 88000

Ukraine

Site GB44009

Bebington,

United Kingdom

Site GB44003

Belfast,

United Kingdom

Site GB44004

Bristol, BS28HW

United Kingdom

Site GB44014

Cambridge,

United Kingdom

Site GB44005

Cardiff, CF4 4XN

United Kingdom

Site GB44002

Glasgow,

United Kingdom

Site GB44006

London,

United Kingdom

Site GB44007

Manchester, M20 4BX

United Kingdom

Site GB44008

Northwood,

United Kingdom

Site GB44016

Nottingham, NG5 1PB

United Kingdom

Site GB44001

Sutton,

United Kingdom