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

Who is this study for? Adult patients with prostate cancer
What treatments are being studied? Enzalutamide+Abiraterone acetate+Prednisone
Status: Recruiting
Location: See all (232) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Alaska
Site US10052
COMPLETED
Anchorage
Arizona
Site US10011
COMPLETED
Tucson
California
Site US10009
COMPLETED
Los Angeles
Site US10040
COMPLETED
Los Angeles
Site US10067
RECRUITING
Orange
Site US10008
COMPLETED
San Bernardino
Site US10042
COMPLETED
San Diego
Site US10028
COMPLETED
Stanford
Colorado
Site US10001
COMPLETED
Aurora
Site US10017
COMPLETED
Denver
Washington, D.c.
Site US10050
COMPLETED
Washington D.c.
Florida
Site US10049
COMPLETED
Daytona Beach
Site US10048
WITHDRAWN
Jacksonville
Illinois
Site US10002
ACTIVE_NOT_RECRUITING
Chicago
Springfield Clinic, LLP
ACTIVE_NOT_RECRUITING
Springfield
Indiana
Site US10007
COMPLETED
Jeffersonville
Kansas
University of Kansas Medical Center
ACTIVE_NOT_RECRUITING
Kansas City
Site US10066
ACTIVE_NOT_RECRUITING
Lenexa
Maryland
Site US10029
COMPLETED
Towson
Missouri
Site US10032
COMPLETED
St Louis
North Carolina
Site US10030
COMPLETED
Chapel Hill
Site US10062
ACTIVE_NOT_RECRUITING
Charlotte
Site US10020
WITHDRAWN
Concord
Site US10031
TERMINATED
Greensboro
Eastern Urological Associates
COMPLETED
Greenville
Site US10046
COMPLETED
Winston-salem
Nebraska
Nebraska Medical Hospital
ACTIVE_NOT_RECRUITING
Omaha
Site US10023
ACTIVE_NOT_RECRUITING
Omaha
New Jersey
Site US10004
ACTIVE_NOT_RECRUITING
Hackensack
New York
Site US10024
ACTIVE_NOT_RECRUITING
Garden City
Site US10055
COMPLETED
New York
Site US10059
COMPLETED
New York
Hudson Valley Urology, PC
ACTIVE_NOT_RECRUITING
Poughkeepsie
Site US10053
COMPLETED
Syracuse
Ohio
Site US10035
COMPLETED
Cincinnati
Oregon
Site US10022
COMPLETED
Springfield
Pennsylvania
Site US10027
COMPLETED
Lancaster
Site US10005
ACTIVE_NOT_RECRUITING
Pittsburgh
South Carolina
Site US10018
ACTIVE_NOT_RECRUITING
Charleston
Carolina Urologic Research Center
ACTIVE_NOT_RECRUITING
Myrtle Beach
Site US10003
WITHDRAWN
Myrtle Beach
Tennessee
Site US10041
ACTIVE_NOT_RECRUITING
Nashville
Texas
Site US10010
ACTIVE_NOT_RECRUITING
Dallas
Site US10034
COMPLETED
Houston
Site US10043
ACTIVE_NOT_RECRUITING
Houston
Virginia
Site US10014
COMPLETED
Norfolk
Site US10015
ACTIVE_NOT_RECRUITING
Virginia Beach
Washington
Site US10038
COMPLETED
Seattle
Virginia Mason Medical Center
ACTIVE_NOT_RECRUITING
Seattle
Wisconsin
Site US10021
ACTIVE_NOT_RECRUITING
Madison
Other Locations
Argentina
Site AR54005
COMPLETED
Buenos Aires
Site AR54008
ACTIVE_NOT_RECRUITING
Buenos Aires
Site AR54003
COMPLETED
Cordorba
Site AR54007
ACTIVE_NOT_RECRUITING
Rosario
Site AR54002
COMPLETED
San Miguel De Tucumán
Site AR54006
ACTIVE_NOT_RECRUITING
San Miguel De Tucumán
Australia
Site AU61014
COMPLETED
Albury
Site AU61006
ACTIVE_NOT_RECRUITING
Ashford
Site AU61019
ACTIVE_NOT_RECRUITING
Ballarat
Site AU61007
COMPLETED
East Bentleigh
Site AU61009
COMPLETED
Malvern
Site AU61021
COMPLETED
Parkville
Site AU61008
COMPLETED
South Brisbane
Site AU61016
ACTIVE_NOT_RECRUITING
St Albans
Site AU61001
COMPLETED
Tweed Heads
Site AU61012
COMPLETED
Wahroonga
Site AU61017
ACTIVE_NOT_RECRUITING
Wahroonga
Site AU61004
ACTIVE_NOT_RECRUITING
Westmead
Austria
Site AT43001
ACTIVE_NOT_RECRUITING
Vienna
Belgium
Site BE32009
ACTIVE_NOT_RECRUITING
Anderlecht
Site BE32004
ACTIVE_NOT_RECRUITING
Brussels
Site BE32005
ACTIVE_NOT_RECRUITING
Ghent
Site BE32011
ACTIVE_NOT_RECRUITING
Ghent
Site BE32007
COMPLETED
Hasselt
Site BE32002
ACTIVE_NOT_RECRUITING
Kortrijk
Site BE32008
COMPLETED
Leuven
Site BE32001
ACTIVE_NOT_RECRUITING
Liège
Site BE32003
COMPLETED
Turnhout
Brazil
Site BR55009
ACTIVE_NOT_RECRUITING
Bahia
Site BR55008
ACTIVE_NOT_RECRUITING
Campinas
Site BR55004
RECRUITING
Ijuí
Site BR55011
ACTIVE_NOT_RECRUITING
Jaú
Site BR55007
ACTIVE_NOT_RECRUITING
Porto Alegre
Site BR55002
ACTIVE_NOT_RECRUITING
Rio Grande
Site BR55010
ACTIVE_NOT_RECRUITING
Santo André
Canada
Site CA15019
ACTIVE_NOT_RECRUITING
Abbotsford
Site CA15001
TERMINATED
Granby
Site CA15020
ACTIVE_NOT_RECRUITING
Greenville
Site CA15003
COMPLETED
Kingston
Site CA15011
ACTIVE_NOT_RECRUITING
Montreal
Site CA15017
ACTIVE_NOT_RECRUITING
Oakville
Site CA15022
ACTIVE_NOT_RECRUITING
Québec
Site CA15021
ACTIVE_NOT_RECRUITING
Toronto
Chile
Site CL56004
ACTIVE_NOT_RECRUITING
Ix Region
Site CL56002
COMPLETED
Santiago
Site CL56005
ACTIVE_NOT_RECRUITING
Santiago
Site CL56007
ACTIVE_NOT_RECRUITING
Santiago
Site CL56001
ACTIVE_NOT_RECRUITING
Viña Del Mar
Site CL56006
ACTIVE_NOT_RECRUITING
Viña Del Mar
China
Site CN86003
ACTIVE_NOT_RECRUITING
Hubei
Site CN86010
ACTIVE_NOT_RECRUITING
Hunan
Site CN86005
ACTIVE_NOT_RECRUITING
Nanjing
Denmark
Site DK45002
ACTIVE_NOT_RECRUITING
Aalborg
Site DK45003
ACTIVE_NOT_RECRUITING
Aarhus
Site DK45001
COMPLETED
Copenhagen
Site DK45004
ACTIVE_NOT_RECRUITING
Herlev
Site DK45006
COMPLETED
Vejle
Finland
Site FL35802
ACTIVE_NOT_RECRUITING
Tampere
Site FL35805
ACTIVE_NOT_RECRUITING
Turku
France
Site FR33021
COMPLETED
Bordeaux
Site FR33008
COMPLETED
La Roche-sur-yon
Site FR33010
COMPLETED
Lille
Site FR33002
COMPLETED
Lyon
Site FR33020
COMPLETED
Montpellier
Site FR33006
COMPLETED
Nîmes
Site FR33003
COMPLETED
Paris
Site FR33017
COMPLETED
Paris
Site FR33001
COMPLETED
Saint-herblain
Site FR33019
COMPLETED
Strasbourg
Site FR33022
COMPLETED
Strasbourg
Site FR33004
COMPLETED
Villejuif
Georgia
Site GE99501
COMPLETED
Tbilisi
Germany
Site DE49010
ACTIVE_NOT_RECRUITING
Bonn
Site DE49001
COMPLETED
Duisburg
Site DE49003
ACTIVE_NOT_RECRUITING
Hamburg
Site DE49013
COMPLETED
Hamburg
Site DE49006
ACTIVE_NOT_RECRUITING
Mannheim
Site DE49004
COMPLETED
Nürtingen
Site DE49007
COMPLETED
Waldshut-tiengen
Hong Kong Special Administrative Region
Site HK85202
ACTIVE_NOT_RECRUITING
Hong Kong
Israel
Site IL97206
RECRUITING
Haifa
Site IL97205
ACTIVE_NOT_RECRUITING
Jerusalem
Site IL97202
COMPLETED
Peth Tikva
Site IL97204
COMPLETED
Ramat Gan
Site IL97203
COMPLETED
Tzrifin Beer Yakov
Italy
Site IT39001
COMPLETED
Arezzo
Site IT39011
ACTIVE_NOT_RECRUITING
Candiolo
Site IT39004
ACTIVE_NOT_RECRUITING
Cremona
Site IT39008
ACTIVE_NOT_RECRUITING
Faenza (ra)
Site IT39002
COMPLETED
Forlì
Site IT39005
COMPLETED
Roma
Site IT39009
ACTIVE_NOT_RECRUITING
Toscana
Site IT39006
ACTIVE_NOT_RECRUITING
Trento
Japan
Nippon Medical School Hospital
ACTIVE_NOT_RECRUITING
Bunkyo-ku
Chiba cancer center
ACTIVE_NOT_RECRUITING
Chiba
Harasanshin hospital
ACTIVE_NOT_RECRUITING
Fukuoka
Kyushu University Hospital
COMPLETED
Higashiku
Kagawa University Hospital
ACTIVE_NOT_RECRUITING
Kida-gun
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
COMPLETED
Koutou-ku
Kyoto University hospital
ACTIVE_NOT_RECRUITING
Kyoto
Gunma University Hospital
ACTIVE_NOT_RECRUITING
Maebashi
Niigata University Medical and Dental Hospital
COMPLETED
Niigata
Osaka Metropolitan University Hospital
ACTIVE_NOT_RECRUITING
Osaka
Toho University Sakura Medical Center
ACTIVE_NOT_RECRUITING
Sakura-shi
Kindai University Hospital
ACTIVE_NOT_RECRUITING
Sayama
Yamaguchi University Hospital
ACTIVE_NOT_RECRUITING
Ube
Yokohama City University Medical Center
ACTIVE_NOT_RECRUITING
Yokohama
Malaysia
Site MY60001
COMPLETED
Kuching
Netherlands
Site NL31010
ACTIVE_NOT_RECRUITING
Amsterdam
Site NL31009
ACTIVE_NOT_RECRUITING
Den Helder
Site NL31004
ACTIVE_NOT_RECRUITING
Maastricht
Site NL31011
ACTIVE_NOT_RECRUITING
Rotterdam
New Zealand
Site NZ64002
ACTIVE_NOT_RECRUITING
Auckland
Site NZ64005
ACTIVE_NOT_RECRUITING
Dunedin
Site NZ64001
ACTIVE_NOT_RECRUITING
Hamilton
Norway
Site NO47001
ACTIVE_NOT_RECRUITING
Stavanger
Poland
Site PL48002
ACTIVE_NOT_RECRUITING
Gdansk
Site PL48001
ACTIVE_NOT_RECRUITING
Mysłowice
Site PL48004
COMPLETED
Pozman
Site PL48005
ACTIVE_NOT_RECRUITING
Słupsk
Site PL48003
ACTIVE_NOT_RECRUITING
Wroclaw
Republic of Korea
Site KR82008
ACTIVE_NOT_RECRUITING
Busan
Site KR82005
COMPLETED
Seongnam-si
Site KR82012
ACTIVE_NOT_RECRUITING
Seongnam-si
Site KR82001
ACTIVE_NOT_RECRUITING
Seoul
Site KR82002
ACTIVE_NOT_RECRUITING
Seoul
Site KR82003
COMPLETED
Seoul
Site KR82004
COMPLETED
Seoul
Site KR82007
ACTIVE_NOT_RECRUITING
Seoul
Site KR82009
ACTIVE_NOT_RECRUITING
Seoul
Site KR82011
ACTIVE_NOT_RECRUITING
Seoul
Republic of Moldova
Site MD37301
ACTIVE_NOT_RECRUITING
Chisinau
Romania
Site RO40003
ACTIVE_NOT_RECRUITING
Bucharest
Site RO40001
ACTIVE_NOT_RECRUITING
Cluj-napoca
Site RO40004
ACTIVE_NOT_RECRUITING
Cluj-napoca
Russian Federation
Site RU70008
ACTIVE_NOT_RECRUITING
Ivanovo
Site RU70001
ACTIVE_NOT_RECRUITING
Moscow
Site RU70005
ACTIVE_NOT_RECRUITING
Omsk
Site RU70003
ACTIVE_NOT_RECRUITING
Saint Petersburg
Site RU70006
ACTIVE_NOT_RECRUITING
Saint Petersburg
Site RU70009
ACTIVE_NOT_RECRUITING
Saint Petersburg
Serbia
Site RS38101
ACTIVE_NOT_RECRUITING
Belgrade
Site RS38102
COMPLETED
Belgrade
Slovakia
Site SK10223
ACTIVE_NOT_RECRUITING
Bratislava
Site SK42106
COMPLETED
Košice
Site SK42109
ACTIVE_NOT_RECRUITING
Košice
Site SK42105
ACTIVE_NOT_RECRUITING
Nitra
Site SK42103
ACTIVE_NOT_RECRUITING
Prešov
Site SK42108
ACTIVE_NOT_RECRUITING
Trenčín
Site SK42107
ACTIVE_NOT_RECRUITING
Žilina
South Africa
Site ZA27001
COMPLETED
George
Spain
Site ES34003
ACTIVE_NOT_RECRUITING
Barcelona
Site ES34004
WITHDRAWN
Barcelona
Site ES34007
COMPLETED
Barcelona
Site ES34011
COMPLETED
Girona
Site ES34001
COMPLETED
Madrid
Site ES34008
ACTIVE_NOT_RECRUITING
Madrid
Site ES34012
COMPLETED
Madrid
Site ES34005
COMPLETED
Pamplona
Site ES34014
ACTIVE_NOT_RECRUITING
Salamanca
Site ES34010
ACTIVE_NOT_RECRUITING
Santiago De Compostela
Sweden
Site SE46001
COMPLETED
Gothenburg
Site SE46003
ACTIVE_NOT_RECRUITING
Umeå
Taiwan
Site TW88607
ACTIVE_NOT_RECRUITING
Guishan
Site TW88601
COMPLETED
Kaohsiung City
Site TW88603
ACTIVE_NOT_RECRUITING
Kaohsiung City
Site TW88602
ACTIVE_NOT_RECRUITING
Taichung
Site TW88606
ACTIVE_NOT_RECRUITING
Taipei
Thailand
Site TH66002
COMPLETED
Bangkok
Site TH66001
ACTIVE_NOT_RECRUITING
Hat Yai
Turkey
Site TR90002
ACTIVE_NOT_RECRUITING
Beşevler
United Kingdom
Site GB44009
COMPLETED
Bebington
Site GB44003
COMPLETED
Belfast
Site GB44004
COMPLETED
Bristol
Site GB44014
ACTIVE_NOT_RECRUITING
Cambridge
Site GB44005
ACTIVE_NOT_RECRUITING
Cardiff
Site GB44002
COMPLETED
Glasgow
Site GB44006
ACTIVE_NOT_RECRUITING
London
Site GB44007
ACTIVE_NOT_RECRUITING
Manchester
Site GB44008
COMPLETED
Northwood
Site GB44016
ACTIVE_NOT_RECRUITING
Nottingham
Site GB44001
ACTIVE_NOT_RECRUITING
Sutton
Contact Information
Primary
Astellas Pharma Global Development
astellas.registration@astellas.com
800-888-7704
Time Frame
Start Date: 2016-12-22
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 900
Treatments
Experimental: enzalutamide
Subjects will receive enzalutamide orally once daily at the same time each day
Experimental: enzalutamide plus abiraterone acetate and 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 once daily
Experimental: Enzalutamide plus leuprolide acetate
Subjects enrolling from study MDV3100-13 (EMBARK) study may receive leuprolide acetate once every 12 weeks in addition to enzalutamide once daily
Sponsors
Collaborators: Pfizer
Leads: Astellas Pharma Global Development, Inc.

This content was sourced from clinicaltrials.gov

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