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RECRUITING

NCT02960022

PHASE2

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

Sponsor: Astellas Pharma Global Development, Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

900

Start Date

2016-12-22

Completion Date

2029-07-31

Last Updated

2025-12-17

Healthy Volunteers

Conditions

Prostate Cancer

Interventions

DRUG

enzalutamide

Subjects will receive enzalutamide orally once daily at the same time each day.

DRUG

abiraterone acetate

Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

DRUG

prednisone

Subjects enrolling from study 9785-CL-0011 or MDV3100-10 (PLATO) study may receive abiraterone acetate once daily and prednisone twice daily, in addition to enzalutamide

DRUG

Leuprolide acetate

Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily

Inclusion Criteria: * Subject must currently be receiving enzalutamide 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 the subject was receiving 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.

Locations (241)

Site US10052

Anchorage, Alaska, United States

Site US10011

Tucson, Arizona, United States

Site US10040

Los Angeles, California, United States

Site US10009

Los Angeles, California, United States

Site US10067

Orange, California, United States

Site US10008

San Bernardino, California, United States

Site US10042

San Diego, California, United States

Site US10028

Stanford, California, United States

Site US10001

Aurora, Colorado, United States

Site US10017

Denver, Colorado, United States

Site US10050

Washington D.C., District of Columbia, United States

Site US10049

Daytona Beach, Florida, United States

Site US10048

Jacksonville, Florida, United States

Site US10002

Chicago, Illinois, United States

Springfield Clinic, LLP

Springfield, Illinois, United States

Site US10007

Jeffersonville, Indiana, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Site US10066

Lenexa, Kansas, United States

Site US10029

Towson, Maryland, United States

Site US10032

St Louis, Missouri, United States

Nebraska Medical Hospital

Omaha, Nebraska, United States

Site US10023

Omaha, Nebraska, United States

Site US10004

Hackensack, New Jersey, United States

Site US10024

Garden City, New York, United States

Site US10055

New York, New York, United States

Site US10059

New York, New York, United States

Hudson Valley Urology, PC

Poughkeepsie, New York, United States

Site US10053

Syracuse, New York, United States

Site US10030

Chapel Hill, North Carolina, United States

Site US10062

Charlotte, North Carolina, United States

Site US10020

Concord, North Carolina, United States

Site US10031

Greensboro, North Carolina, United States

Eastern Urological Associates

Greenville, North Carolina, United States

Site US10046

Winston-Salem, North Carolina, United States

Site US10035

Cincinnati, Ohio, United States

Site US10022

Springfield, Oregon, United States

Site US10027

Lancaster, Pennsylvania, United States

Site US10005

Pittsburgh, Pennsylvania, United States

Site US10018

Charleston, South Carolina, United States

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Site US10003

Myrtle Beach, South Carolina, United States

Site US10041

Nashville, Tennessee, United States

Site US10010

Dallas, Texas, United States

Site US10034

Houston, Texas, United States

Site US10043

Houston, Texas, United States

Site US10014

Norfolk, Virginia, United States

Site US10015

Virginia Beach, Virginia, United States

Virginia Mason Medical Center

Seattle, Washington, United States

Site US10038

Seattle, Washington, United States

Site US10021

Madison, Wisconsin, United States

Site AR54005

Buenos Aires, Buenos Aires F.D., Argentina

Site AR54007

Rosario, Santa Fe Province, Argentina

Site AR54008

Buenos Aires, Argentina

Site AR54003

Cordorba, Argentina

Site AR54006

San Miguel de Tucumán, Argentina

Site AR54002

San Miguel de Tucumán, Argentina

Site AU61014

Albury, New South Wales, Australia

Site AU61001

Tweed Heads, New South Wales, Australia

Site AU61012

Wahroonga, New South Wales, Australia

Site AU61017

Wahroonga, New South Wales, Australia

Site AU61006

Ashford, Australia

Site AU61019

Ballarat, Australia

Site AU61007

East Bentleigh, Australia

Site AU61009

Malvern, Australia

Site AU61021

Parkville, Australia

Site AU61008

South Brisbane, Australia

Site AU61016

St Albans, Australia

Site AU61004

Westmead, Australia

Site AT43001

Vienna, Austria

Site BE32002

Kortrijk, West-Vlaanderen, Belgium

Site BE32009

Anderlecht, Belgium

Site BE32004

Brussels, Belgium

Site BE32005

Ghent, Belgium

Site BE32011

Ghent, Belgium

Site BE32007

Hasselt, Belgium

Site BE32008

Leuven, Belgium

Site BE32001

Liège, Belgium

Site BE32003

Turnhout, Belgium

Site BR55007

Porto Alegre, Rio Grande do Sul, Brazil

Site BR55009

Bahia, Brazil

Site BR55008

Campinas, Brazil

Site BR55004

Ijuí, Brazil

Site BR55011

Jaú, Brazil

Site BR55002

Rio Grande, Brazil

Site BR55010

Santo André, Brazil

Site CA15003

Kingston, Ontario, Canada

Site CA15021

Toronto, Ontario, Canada

Site CA15001

Granby, Quebec, Canada

Site CA15019

Abbotsford British Columbia, Canada

Site CA15020

Greenville, Canada

Site CA15011

Montreal, Canada

Site CA15017

Oakville, Canada

Site CA15022

Québec, Canada

Site CL56006

Viña del Mar, Región de Valparaíso, Chile

Site CL56007

Santiago, RM, Chile

Site CL56005

Santiago, RM, Chile

Site CL56004

IX Region, Chile

Site CL56002

Santiago, Chile

Site CL56001

Viña del Mar, Chile

Site CN86003

Hubei, China

Site CN86010

Hunan, China

Site CN86005

Nanjing, China

Site CZ42004

Olomouc, Czechia

Site CZ42002

Olomouc, Czechia

Site CZ42001

Prague, Czechia

Site CZ42003

Prague, Czechia

Site DK45002

Aalborg, North Denmark, Denmark

Site DK45003

Aarhus, Denmark

Site DK45001

Copenhagen, Denmark

Site DK45004

Herlev, Denmark

Site DK45006

Vejle, Denmark

Site FL35802

Tampere, Finland

Site FL35805

Turku, Finland

Site FR33021

Bordeaux, France

Site FR33008

La Roche-sur-Yon, France

Site FR33010

Lille, France

Site FR33002

Lyon, France

Site FR33020

Montpellier, France

Site FR33006

Nîmes, France

Site FR33003

Paris, France

Site FR33017

Paris, France

Site FR33001

Saint-Herblain, France

Site FR33019

Strasbourg, France

Site FR33022

Strasbourg, France

Site FR33004

Villejuif, France

Site GE99501

Tbilisi, Georgia

Site DE49004

Nürtingen, Baden-Wurttemberg, Germany

Site DE49007

Waldshut-Tiengen, Baden-Wurttemberg, Germany

Site DE49006

Mannheim, DE, Germany

Site DE49001

Duisburg, North Rhine-Westphalia, Germany

Site DE49010

Bonn, Germany

Site DE49003

Hamburg, Germany

Site DE49013

Hamburg, Germany

Site HK85202

Hong Kong, Hong Kong

Site IL97206

Haifa, 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, 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, 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, Japan

Kindai University Hospital

Sayama, Osaka, 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, Japan

Harasanshin hospital

Fukuoka, Japan

Kyoto University hospital

Kyoto, Japan

Niigata University Medical and Dental Hospital

Niigata, Japan

Osaka Metropolitan University Hospital

Osaka, Japan

Site MY60001

Kuching, Malaysia

Site MD37301

Chisinau, Moldova

Site NL31010

Amsterdam, Netherlands

Site NL31009

Den Helder, Netherlands

Site NL31004

Maastricht, Netherlands

Site NL31011

Rotterdam, Netherlands

Site NZ64002

Auckland, New Zealand

Site NZ64005

Dunedin, 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, Poland

Site PL48011

Warsaw, Poland

Site PL48003

Wroclaw, Poland

Site RO40003

Bucharest, Romania

Site RO40001

Cluj-Napoca, Romania

Site RO40004

Cluj-Napoca, Romania

Site RU70008

Ivanovo, Russia

Site RU70001

Moscow, Russia

Site RU70005

Omsk, Russia

Site RU70009

Saint Petersburg, Russia

Site RU70003

Saint Petersburg, Russia

Site RU70006

Saint Petersburg, Russia

Site RS38102

Belgrade, Serbia

Site RS38101

Belgrade, Serbia

Site SK10223

Bratislava, Slovakia

Site SK42109

Košice, Slovakia

Site SK42106

Košice, Slovakia

Site SK42105

Nitra, Slovakia

Site SK42103

Prešov, Slovakia

Site SK42108

Trenčín, Slovakia

Site SK42107

Žilina, Slovakia

Site ZA27001

George, South Africa

Site KR82008

Busan, South Korea

Site KR82012

Seongnam-si, South Korea

Site KR82005

Seongnam-si, South Korea

Site KR82009

Seoul, South Korea

Site KR82007

Seoul, South Korea

Site KR82011

Seoul, 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, Spain

Site ES34003

Barcelona, Spain

Site ES34004

Barcelona, Spain

Site ES34011

Girona, Spain

Site ES34012

Madrid, Spain

Site ES34001

Madrid, Spain

Site ES34008

Madrid, Spain

Site ES34005

Pamplona, Spain

Site ES34014

Salamanca, Spain

Site ES34010

Santiago de Compostela, Spain

Site SE46001

Gothenburg, Sweden

Site SE46003

Umeå, Sweden

Site TW88607

Guishan, Taiwan

Site TW88603

Kaohsiung City, Taiwan

Site TW88601

Kaohsiung City, Taiwan

Site TW88602

Taichung, Taiwan

Site TW88606

Taipei, Taiwan

Site TH66001

Hat Yai, Changwat Songkhla, Thailand

Site TH66002

Bangkok, Thailand

Site TR90002

Beşevler, Ankara, Turkey (Türkiye)

Site UA38004

Dnipro, Ukraine

Site UA38005

Kharkiv, Ukraine

Site UA38001

Kyiv, Ukraine

Site UA38003

Uzhhorod, Ukraine

Site GB44009

Bebington, United Kingdom

Site GB44003

Belfast, United Kingdom

Site GB44004

Bristol, United Kingdom

Site GB44014

Cambridge, United Kingdom

Site GB44005

Cardiff, United Kingdom

Site GB44002

Glasgow, United Kingdom

Site GB44006

London, United Kingdom

Site GB44007

Manchester, United Kingdom

Site GB44008

Northwood, United Kingdom

Site GB44016

Nottingham, United Kingdom

Site GB44001

Sutton, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (241)