The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: A Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Official Title: A Phase 2 Open-label Extension Study for Subjects With Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Study ID: NCT02960022
Brief 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). 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
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, 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, Saint 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, Caba, Argentina
Site AR54007, Rosario, Santa Fé, Argentina
Site AR54003, Cordorba, , Argentina
Site AR54006, San Miguel de Tucuman, , Argentina
Site AR54002, Tucuman, , Argentina
Site AU61014, Albury, New South Wales, Australia
Site AU61001, Tweed Heads, 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 AU61004, Westmead, , Australia
Site AT43001, Vienna, , Austria
Site BE32002, Kortrijk, West-Vlaanderen, Belgium
Site BE32009, Anderlecht, , Belgium
Site BE32004, Brussels, , Belgium
Site BE32005, Gent, , Belgium
Site BE32011, Gent, , Belgium
Site BE32007, Hasselt, , Belgium
Site BE32008, Leuven, , Belgium
Site BE32001, Liege, , 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, Jau, , Brazil
Site BR55002, Rio Grande Do Sul, , Brazil
Site BR55010, Santo Andre, , Brazil
Site CA15003, Kingston, Ontario, Canada
Site CA15021, Toronto, Ontario, Canada
Site CA15001, Granby, Quebec, Canada
Site CA15019, Abbotsford, , Canada
Site CA15020, Greenville, , Canada
Site CA15011, Montreal, , Canada
Site CA15017, Oakville, , Canada
Site CA15022, Quebec, , Canada
Site CL56007, Santiago, RM, Chile
Site CL56005, Santiago, RM, Chile
Site CL56006, Vina Del Mar, Valparaiso, Chile
Site CL56004, IX Region, , Chile
Site CL56002, Santiago, , Chile
Site CL56001, Vina del Mar, , Chile
Site CZ42004, Olomouc, , Czechia
Site CZ42002, Olomouc, , Czechia
Site CZ42003, Praha 2, , Czechia
Site CZ42001, Praha 6, , Czechia
Site DK45002, Aalborg, Nordjylland, 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 FR33008, La Roche sur Yon, , France
Site FR33010, Lille, , France
Site FR33002, Lyon Cedex 3, , France
Site FR33020, Montpellier Cedex, , France
Site FR33006, Nimes, , 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-Württemberg, Germany
Site DE49007, Waldshut-Tiengen, Baden-Württemberg, Germany
Site DE49006, Mannheim, DE, Germany
Site DE49001, Duisburg, NRW, Germany
Site DE49010, Bonn, , Germany
Site DE49003, Hamburg, , Germany
Site DE49013, Hamburg, , Germany
Site HK85202, Hong Kong, , Hong Kong
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, Forli, , Italy
Site IT39005, Roma, , Italy
Site IT39006, Trento, , Italy
Toho University Sakura Medical Center, Sakura-shi, Chiba, Japan
Kyushu University Hospital, Higashi-ku, Fukuoka, Japan
Gunma University Hospital, Maebashi-shi, Gunma, Japan
Kagawa University Hospital, Kida-gun, Kagawa, 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 KR82008, Busan, , Korea, Republic of
Site KR82012, Seongnam-si, , Korea, Republic of
Site KR82005, Seongnam-si, , Korea, Republic of
Site KR82009, Seoul, , Korea, Republic of
Site KR82007, Seoul, , Korea, Republic of
Site KR82011, Seoul, , Korea, Republic of
Site KR82001, Seoul, , Korea, Republic of
Site KR82002, Seoul, , Korea, Republic of
Site KR82003, Seoul, , Korea, Republic of
Site KR82004, Seoul, , Korea, Republic of
Site MY60001, Kuching, , Malaysia
Site MD37301, Chisinau, , Moldova, Republic of
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, Myslowice, , Poland
Site PL48004, Pozman, , Poland
Site PL48005, Slupsk, , Poland
Site PL48003, Wrocław, , Poland
Site RO40003, Bucuresti, , Romania
Site RU70001, Moscow, , Russian Federation
Site RU70001, Moscow, , Russian Federation
Site RU70003, St. Petersburg, , Russian Federation
Site RS38102, Belgrade, , Serbia
Site RS38101, Belgrade, , Serbia
Site SK10223, Bratislava, , Slovakia
Site SK42109, Kosice, , Slovakia
Site SK42106, Kosice, , Slovakia
Site SK42105, Nitra, , Slovakia
Site SK42103, Presov, , Slovakia
Site SK42108, Trencin, , Slovakia
Site SK42107, Zilina, , Slovakia
Site ZA27001, George, , South Africa
Site ES34007, Barcelona, , Spain
Site ES34003, Barcelona, , Spain
Site ES34004, Barcelona, , Spain
Site ES34011, Gerona, , Spain
Site ES34012, Madrid, , Spain
Site ES34001, Madrid, , Spain
Site ES34008, Madrid, , Spain
Site ES34005, Pamplona, , Spain
Site ES34010, Santiago de Compostela, , Spain
Site SE46001, Göteborg, , Sweden
Site SE46003, Umeå, , Sweden
Site TW88607, Gueishan, , Taiwan
Site TW88603, Kaohsiung, , Taiwan
Site TW88601, Kaohsiung, , Taiwan
Site TW88602, Taichung, , Taiwan
Site TW88606, Taipei, , Taiwan
Site TH66001, Hat Yai, Songkla, Thailand
Site TH66002, Bangkok, , Thailand
Site TR90002, Besevler, Ankara, Turkey
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
Name: Associate Medical Director
Affiliation: Astellas Pharma Global Development, Inc.
Role: STUDY_DIRECTOR